Publications

Expert Meetings

Quality
  • All
  • Quality By Design
  • Informing ICH E6 Renovation
  • Diversity
  • Analysis of ClinicalTrials.gov
  • Engaging Stakeholders in Trial Design
  • Recruitment
  • Pregnancy Testing
  • State of Clinical Trials
  • COVID 19
  • Measuring Trials Transformation
Investigators and Sites
  • All
  • Investigator Community
  • Investigator Qualification
  • Study Start-Up
Digital Health Trials
  • All
  • Planning Decentralized Trials
  • Developing Novel Endpoints
  • Selecting and Testing Digital Health Technology
  • Testing a Digital Health Technology
  • Managing Data
  • Delivering an Investigational Product
  • Supporting Sites
  • Interacting with Regulators
Novel Trial Designs
  • All
  • Real World Data
  • Master Protocol Studies
  • Trials in Clinical Practice
  • ABDD HABP/VABP
  • ABDD Peds Trials
  • ABDD Streamlining HABP/VABP
  • ABDD Unmet Need
  • Registry Trials
  • Electronic Healthcare Data
  • Large Simple Trials
  • Sentinel IMPACT-AFib
  • Using Disease Progression Modeling to Advance Trial Design and Decision Making
Ethics and HRP
  • All
  • Single IRB
  • Informed Consent
  • Safety Reporting
  • Data Monitoring Committees
Patient Engagement
  • All
  • Patient Group Engagement
  • Patient Engagement Collaborative

How Much Evidence Is Enough? Research Sponsor Experiences Seeking Regulatory Acceptance of Digital Health Technology-Derived Endpoints

June 8, 2023
Publication: Digital Biomarkers
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Developing Novel EndpointsPublicationsRelated: Developing Novel Endpoints

Enhancing Diversity and Inclusion in Clinical Trials

January 11, 2023
Publication: Journal of Clinical Pharmacology & Therapeutics
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
DiversityPublicationsRelated: Diversity

Lipid-lowering Treatment Among Older Patients with Atherosclerotic Cardiovascular Disease

December 20, 2022
Publication: Journal of the American Geriatrics Society
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Electronic Healthcare DataPublicationsRelated: Electronic Healthcare Data

Stakeholders’ views on the most and least helpful aspects of the ICH E6 GCP guideline and their aspirations for the revision of ICH E6(R2)

October 31, 2022
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Informing ICH E6 RenovationPublications

Mobilizing the Clinical Trial Ecosystem to Drive Adoption of Master Protocols

September 9, 2022
Publication: Society for Clinical Trials (SCT)
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Master Protocol StudiesPublicationsRelated: Master Protocol Studies

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants – A Randomized Clinical Trial

May 31, 2022
Publication: JAMA Network Open
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Electronic Healthcare DataPublicationsRelated: Sentinel IMPACT-AFibSentinel IMPACT-AFib

PROPHETIC EU: Prospective Identification of Pneumonia in Hospitalized Patients in the Intensive Care Unit in European and United States Cohorts

May 9, 2022
Publication: Open Forum Infectious Disease
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD HABP/VABPPublicationsRelated: ABDD HABP/VABP

High-Intensity Statin Use Among Patients With Atherosclerosis in the U.S.

May 5, 2022
Publication: Journal of the American College of Cardiology
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Electronic Healthcare DataPublications

Stakeholders’ recommendations for revising Good Clinical Practice

June 21, 2021
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Informing ICH E6 RenovationPublicationsRelated: Informing ICH E6 Renovation

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance

May 21, 2021
Publication: Ethics & Human Research
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Single IRBSingle IRB

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

February 12, 2021
Publication: JMIR mHealth Uhealth
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Managing DataPublicationsRelated: Managing DataRelated: Selecting and Testing Digital Health TechnologyRelated: Testing a Digital Health TechnologySelecting and Testing Digital Health TechnologyTesting a Digital Health Technology

Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

January 3, 2021
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsReal World DataRelated: Real World Data

Assessing the Financial Value of Patient Engagement

December 10, 2020
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Patient Group Engagement

Prospective Identification of Pneumonia in Hospitalized Patients in the ICU

December 1, 2020
Publication: CHEST Journal
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD HABP/VABPPublicationsRelated: ABDD HABP/VABP

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

September 29, 2020
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Patient Group EngagementPublicationsRelated: Patient Group Engagement

More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant

August 13, 2020
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Investigator QualificationPublicationsRelated: Investigator Qualification

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

July 3, 2020
Publication: Preprints.org
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Publications

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

June 22, 2020
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRegistry TrialsRelated: Registry Trials

Consensus on Language for Advance Informed Consent in Health Care–Associated Pneumonia Clinical Trials Using a Delphi Process

May 22, 2020
Publication: JAMA Network Open
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD HABP/VABPPublicationsRelated: ABDD HABP/VABP

Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials

March 7, 2020
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Investigator CommunityPublicationsRelated: Investigator Community

Hospital-acquired Pneumonia and Ventilator-associated Pneumonia in Children: A Prospective Natural History and Case-Control Study

March 2, 2020
Publication: The Pediatric Infectious Disease Journal
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD HABP/VABPPublicationsRelated: ABDD HABP/VABP

Improving the Quality Conduct and Efficiency of Clinical Trials with Training: Recommendations for Preparedness and Qualification of Investigators and Delegates

February 1, 2020
Publication: Contemporary Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Investigator QualificationPublicationsRelated: Investigator Qualification

Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

December 10, 2019
Publication: Therapeutic Innovation and Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Planning Decentralized TrialsPublicationsRelated: Interacting with RegulatorsRelated: Planning Decentralized Trials

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

November 6, 2019
Publication: Digital Biomarkers
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Managing DataPublicationsRelated: Managing DataRelated: Selecting and Testing Digital Health TechnologyRelated: Testing a Digital Health TechnologySelecting and Testing Digital Health TechnologyTesting a Digital Health Technology

Improving and sustaining the site investigator community: Recommendations from the Clinical Trials Transformation Initiative

October 17, 2019
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Investigator CommunityPublicationsRelated: Investigator Community

Patient preferences for using mobile technologies in clinical trials

September 11, 2019
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Selecting and Testing Digital Health TechnologySelecting and Testing Digital Health Technology

Resources to assist in the transition to a single IRB model for multisite clinical trials

September 1, 2019
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Single IRBSingle IRB

A systematic review of feasibility studies promoting the use of mobile technologies in clinical research

June 6, 2019
Publication: npj Digital Medicine
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Selecting and Testing Digital Health TechnologySelecting and Testing Digital Health Technology

FDA Catalyst–using FDA’s Sentinel Initiative for large scale pragmatic randomized trials

February 1, 2019
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Electronic Healthcare DataPublicationsRelated: Electronic Healthcare Data

Assessment of the Perceived Acceptability of an Early Enrollment Strategy Using Advance Consent in Health Care–Associated Pneumonia

December 14, 2018
Publication: JAMA Network Open
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD HABP/VABPPublicationsRelated: ABDD HABP/VABP

Acceptability of an early enrollment strategy using advanced consent in healthcare-associated pneumonia: a qualitative descriptive study

December 4, 2018
Publication: JAMA Network Open
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD HABP/VABPPublicationsRelated: ABDD HABP/VABP

Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process

August 12, 2018
Publication: PLoS ONE
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Pregnancy TestingPublicationsRelated: Pregnancy Testing

Pediatric Antibacterial and Antifungal Trials From 2007 to 2017

August 1, 2018
Publication: Pediatrics
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Peds TrialsPublicationsRelated: ABDD Peds Trials

Participant Summary: Site Investigator Perceptions of Mobile Clinical Trials – Summary of Interview Findings

March 27, 2018
Publication: Clinical Trials Transformation Initiative
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Managing DataPublicationsRelated: Managing DataRelated: Selecting and Testing Digital Health TechnologyRelated: Testing a Digital Health TechnologySelecting and Testing Digital Health TechnologyTesting a Digital Health Technology

Participant Summary: Investigator Qualification Summary of Interview Findings

March 27, 2018
Publication: Clinical Trials Transformation Initiative
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Investigator QualificationPublicationsRelated: Investigator Qualification

Participant Summary: Value of Patient Group Engagement Activities Summary of Interview Findings

March 27, 2018
Publication: Clinical Trials Transformation Initiative
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Patient Group EngagementPublicationsRelated: Patient Group Engagement

Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI’s survey of investigators

March 1, 2018
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Peds TrialsPublicationsRelated: ABDD Peds Trials

Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative

February 21, 2018
Publication: Contemporary Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRecruitmentRelated: Recruitment

Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010–2016: A Systematic Literature Review

February 21, 2018
Publication: Digital Biomarkers
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Developing Novel EndpointsPublicationsRelated: Developing Novel Endpoints

The Clinical Trials Transformation Initiative. One Decade of Impact. One Vision Ahead.

February 16, 2018
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Publications

Advancing Pediatric Antibacterial Drug Development: A Critical Need to Reinvent our Approach

February 8, 2018
Publication: Journal of the Pediatric Infectious Diseases Society
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Peds TrialsPublicationsRelated: ABDD Peds Trials

Perceived Barriers to Pediatrician and Family Practitioner Participation in Pediatric Clinical Trials: Findings from the Clinical Trials Transformation Initiative

December 10, 2017
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Peds TrialsPublicationsRelated: ABDD Peds Trials

Parents’ perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

December 10, 2017
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Peds TrialsPublicationsRelated: ABDD Peds Trials

Cost Drivers of a Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase 3 Clinical Trial

August 17, 2017
Publication: Clinical Infectious Diseases
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD HABP/VABPPublicationsRelated: ABDD HABP/VABP

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials

August 1, 2017
Publication: Therapeutic Innovation & Regulatory Science (TIRS)
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Patient Group EngagementPublicationsRelated: Patient Group Engagement

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative

May 13, 2017
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Data Monitoring CommitteesNewsPublicationsRelated: Data Monitoring Committees

Sponsors’ and investigative staffs’ perceptions of the current investigational new drug safety reporting process in oncology trials

March 26, 2017
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Safety ReportingSafety Reporting

One and done: Reasons principal investigators conduct only one FDA-regulated drug trial

March 8, 2017
Publication: Contemporary Clinical Trials Communications
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Investigator CommunityPublicationsRelated: Investigator Community

Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project

December 15, 2016
Publication: JMIR Cancer
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Safety ReportingSafety Reporting

Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees

December 13, 2016
Publication: JAMA
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Data Monitoring CommitteesPublicationsRelated: Data Monitoring Committees

Understanding the functions and operations of data monitoring committees: Survey and focus group findings

November 25, 2016
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Data Monitoring CommitteesPublicationsRelated: Data Monitoring Committees

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis

November 10, 2016
Publication: BMJ Open
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Unmet NeedPublicationsRelated: ABDD Unmet Need

Improving Conduct and Feasibility of Clinical Trials to Evaluate Antibacterial Drugs to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

August 1, 2016
Publication: Clinical Infectious Diseases
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Streamlining HABP/VABPPublicationsRelated: ABDD Streamlining HABP/VABP

How Public–Private Collaborations Are Driving Solutions to the Antibacterial Drug Development Crisis

August 1, 2016
Publication: Clinical Infectious Diseases
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Streamlining HABP/VABPPublicationsRelated: ABDD Streamlining HABP/VABP

Facilitating Antibacterial Drug Development in a Time of Great Need

August 1, 2016
Publication: Clinical Infectious Diseases
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Streamlining HABP/VABPPublicationsRelated: ABDD Streamlining HABP/VABP

Streamlining Safety Data Collection in Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Trials: Recommendations of the Clinical Trials Transformation Initiative Antibacterial Drug Development Project Team

August 1, 2016
Publication: Clinical Infectious Diseases
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Streamlining HABP/VABPPublicationsRelated: ABDD Streamlining HABP/VABP

Participant Summary: IMPACT-AF: Formative Research Summary

July 5, 2016
Publication: Clinical Trials Transformation Initiative
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Electronic Healthcare DataPublicationsRelated: Electronic Healthcare Data

Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

June 17, 2016
Publication: Contemporary Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Informed ConsentPublicationsRelated: Informed Consent

Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

May 18, 2016
Publication: PLoS ONE
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Barriers to Change in the Informed Consent Process: A Systematic Literature Review

May 17, 2016
Publication: IRB: Ethics & Human Research
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Informed ConsentPublicationsRelated: Informed Consent

Enhancing clinical evidence by proactively building quality into clinical trials

April 21, 2016
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsQuality By DesignRelated: Quality By Design

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

March 11, 2016
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Investigator QualificationPublicationsRelated: Investigator Qualification

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey

October 14, 2015
Publication: PLoS ONE
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Patient Group EngagementPublicationsRelated: Patient Group Engagement

The FDA’s Final Rule on Expedited Safety Reporting: Statistical Considerations

October 9, 2015
Publication: Statistics in Biopharmaceutical Research
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Safety ReportingSafety Reporting

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

September 11, 2015
Publication: Annals of the American Thoracic Society
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
ABDD Unmet NeedPublicationsRelated: ABDD Unmet NeedRelated: State of Clinical TrialsState of Clinical Trials

Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey

September 3, 2015
Publication: Applied Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRecruitmentRelated: Recruitment

Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

July 15, 2015
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Informed ConsentPublicationsRelated: Informed Consent

Compliance with Results Reporting at ClinicalTrials.gov

March 12, 2015
Publication: New England Journal of Medicine
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

The Clinical Trials Transformation Initiative: innovation through collaboration

October 31, 2014
Publication: Nature Reviews Drug Discovery
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsState of Clinical Trials

Clinical Trials in Peripheral Vascular Disease: Pipeline and Trial Designs: An Evaluation of the ClinicalTrials.gov Database

September 19, 2014
Publication: Circulation
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND

May 1, 2014
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Safety ReportingSafety Reporting

The Imperative of Overcoming Barriers to the Conduct of Large, Simple Trials

April 9, 2014
Publication: JAMA
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Large Simple TrialsPublicationsRelated: Large Simple Trials

Mini-Sentinel and Clinical Trials Transformation Initiative: Developing approaches to conducting randomized trials using the mini-sentinel distributed database

February 28, 2014
Publication: Mini-sentinel.org
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
Electronic Healthcare DataPublicationsRelated: Electronic Healthcare Data

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

January 30, 2014
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Safety ReportingSafety Reporting

The Landscape of Clinical Trials in Nephrology: A Systematic Review of ClinicalTrials.gov

December 9, 2013
Publication: American Journal of Kidney Diseases
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

November 7, 2013
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Safety ReportingSafety Reporting

Using ClinicalTrials.gov to Understand the State of Clinical Research in Pulmonary, Critical Care, and Sleep Medicine

October 16, 2013
Publication: AnnalsATS
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

The State of Infectious Diseases Clinical Trials: A Systematic Review of ClinicalTrials.gov

October 16, 2013
Publication: PLoS ONE
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

An Analysis of Registered Clinical Trials in Otolaryngology from 2007 to 2010

October 9, 2013
Publication: Otolaryngology -- Head and Neck Surgery
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Portfolio of Clinical Research in Adult Cardiovascular Disease as Reflected in ClinicalTrials.gov

September 26, 2013
Publication: JAHA
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature

May 10, 2013
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Single IRBSingle IRB

Participants’ Perspectives on Safety Monitoring in Clinical Trials

May 3, 2013
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Safety ReportingSafety Reporting

Characteristics of Oncology Clinical Trials: Insights from a Systematic Analysis of ClinicalTrials.gov

April 29, 2013
Publication: JAMA Internal Medicine
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Are current clinical trials in diabetes addressing important issues in diabetes care?

February 26, 2013
Publication: Diabetologia
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Using Central IRBs for Multicenter Clinical Trials in the United States

January 30, 2013
Publication: PLoS ONE
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Single IRBSingle IRB

Cycle Time Metrics for Multisite Clinical Trials in the United States

January 4, 2013
Publication: Therapeutic Innovation & Regulatory Science
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: Study Start-UpStudy Start-Up

Clinical Trials: Rethinking How We Ensure Quality

November 1, 2012
Publication: Drug Information Journal
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsQuality By DesignRelated: Quality By Design

Status of the Pediatric Clinical Trials Enterprise: An Analysis of the US ClinicalTrials.gov Registry

October 1, 2012
Publication: Pediatrics
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

May 2, 2012
Publication: JAMA
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical Trials

The Database for Aggregate Analysis of ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical Specialty

March 16, 2012
Publication: PLoS ONE
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Impediments to Clinical Research in the United States

March 1, 2012
Publication: Clinical Pharmacology & Therapeutics
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

Monitoring the Quality of Conduct of Clinical Trials: A Survey of Current Practices

June 1, 2011
Publication: Clinical Trials
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsQuality By DesignRelated: Quality By Design

The Clinical Trials Transformation Initiative (CTTI)

April 1, 2011
Publication: Annali dell'Istituto Superiore di Sanità
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

The ClinicalTrials.gov Results Database – Update and Key Issues

March 3, 2011
Publication: The New England Journal of Medicine
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials

The Clinical Trials Transformation Initiative (CTTI): Challenging the Status Quo (link unavailable)

December 1, 2009
Publication: Monitor
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsState of Clinical Trials

Rethinking Randomized Clinical Trials for Comparative Effectiveness Research: The Need for Transformational Change

August 4, 2009
Publication: Annals of Internal Medicine
Quality By Design
Informing ICH E6 Renovation
Analysis of ClinicalTrials.gov
Diversity
Recruitment
Pregnancy Testing
State of Clinical Trials
Engaging Stakeholders in Trial Design
Measuring Trials Transformation
Investigator Community
Investigator Qualification
Site Metrics
Developing Novel Endpoints
Selecting and Testing Digital Health Technology
Testing a Digital Health Technology
Managing Data
Supporting Sites
Planning Decentralized Trials
Delivering an Intervention
Real World Data
Master Protocol Studies
Pragmatic Trials
ABDD HABP/VABP Studies
ABDD Peds Trials
ABDD Streamlining HABP/VABP Trials
ABDD Unmet Need
Registry Trials
Electronic Healthcare Data
Large Simple Trials
Sentinel IMPACT-AFib
Disease Progression Modeling
Single IRB
Safety Reporting
Data Monitoring Committees
Patient Group Engagement
PublicationsRelated: State of Clinical TrialsState of Clinical Trials