Publications

Home Briefing Room Publications

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

in Clinical Trials

CTTI Project: Electronic Healthcare Data

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

in JAMA Network Open

CTTI Project: HABP/VABP Studies

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

in PLoS ONE

CTTI Project: Pregnancy Testing

Pediatric Antibacterial and Antifungal Trials From 2007 to 2017

in Pediatrics

CTTI Project: Peds Trials

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

in Contemporary Clinical Trials

CTTI Project: Recruitment

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

in Digital Biomarkers

CTTI Project: Novel Endpoints

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

in Clinical Trials

CTTI Project: Patient Groups & Clinical Trials

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

in Journal of the Pediatric Infectious Diseases Society

CTTI Project: Peds Trials

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

in Contemporary Clinical Trials Communications

CTTI Project: Peds Trials

Parents' Perceived Obstacles to Pediatric Clinical Trial Participation: Findings from the Clinical Trials Transformation Initiative

in Contemporary Clinical Trials Communications

CTTI Project: Peds Trials

Assessing the Financial Value of Patient Engagement

in Therapeutic Innovation & Regulatory Science (TIRS)

CTTI Project: Patient Groups & Clinical Trials

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

in Therapeutic Innovation & Regulatory Science (TIRS)

CTTI Project: Patient Groups & Clinical Trials

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative

in Clinical Trials

CTTI Project: Data Monitoring Committees (DMCs)

To view the original recommendations document referenced in this publication, click here.

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

in Clinical Trials

CTTI Project: Safety Reporting

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

in Contemporary Clinical Trials Communications

CTTI Project: Investigator Community

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

in JMIR Cancer

CTTI Project: Safety Reporting

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

in JAMA

CTTI Project: Data Monitoring Committees (DMCs)

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

in Clinical Trials

CTTI Project: Data Monitoring Committees (DMCs)

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

in BMJ Open

CTTI Project: 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 Antibacteri

in Clinical Infectious Diseases

CTTI Project: Streamlining HABP/VABP Trials

This peer-reviewed publication is part of the supplement, Facilitating Antibacterial Drug Development in a Time of Great Need, released in Clinical Infectious Diseases.

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

in Clinical Infectious Diseases

CTTI Project: Streamlining HABP/VABP Trials

This peer-reviewed publication is part of the supplement, Facilitating Antibacterial Drug Development in a Time of Great Need, released in Clinical Infectious Diseases.

Facilitating Antibacterial Drug Development in a Time of Great Need

in Clinical Infectious Diseases

CTTI Project: Streamlining HABP/VABP Trials

This peer-reviewed supplement in the journal Clinical Infectious Diseases features collaborative and innovative approaches by CTTI and others to address this pressing public health concern and speed new treatments to patients. The supplement includes 8 articles and was developed in parallel with the release of our Streamlining HABP/VABP Trials Recommendations.

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

in Clinical Infectious Diseases

CTTI Project: Streamlining HABP/VABP Trials

This peer-reviewed publication is part of the supplement, Facilitating Antibacterial Drug Development in a Time of Great Need, released in Clinical Infectious Diseases.

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

in Contemporary Clinical Trials

CTTI Project: Informed Consent

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

in PLoS ONE

CTTI Project: State of Clinical Trials

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

in IRB: Ethics & Human Research

CTTI Project: Informed Consent

Enhancing clinical evidence by proactively building quality into clinical trials

in Clinical Trials

CTTI Project: Quality by Design

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

in Therapeutic Innovation & Regulatory Science

CTTI Project: Investigator Qualification

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

in PLoS ONE

CTTI Project: Patient Groups & Clinical Trials

*CLICK HERE to download the SPSS dataset for this publication. 

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

in Statistics in Biopharmaceutical Research

CTTI Project: Safety Reporting

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

in Annals of the American Thoracic Society

CTTI Project: State of Clinical Trials

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

in Applied Clinical Trials

CTTI Project: Recruitment

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

in Clinical Trials

CTTI Project: Informed Consent

Compliance with Results Reporting at ClinicalTrials.gov

in New England Journal of Medicine

CTTI Project: State of Clinical Trials

*Click here to view the the dataset used for this manuscript. (The first worksheet in this Excel file contains the description and data dictionary; the second worksheet contains the data for the 13,327 studies and all of the variables used in the analysis.)

The Clinical Trials Transformation Initiative: innovation through collaboration

in Nature Reviews Drug Discovery

CTTI Project: State of Clinical Trials

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

in Circulation

CTTI Project: State of Clinical Trials

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

in Therapeutic Innovation & Regulatory Science

CTTI Project: Safety Reporting

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

in JAMA

CTTI Project: Large Simple Trials

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

in Mini-sentinel.org

CTTI Project: Electronic Healthcare Data

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

in Therapeutic Innovation & Regulatory Science

CTTI Project: Safety Reporting

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

in American Journal of Kidney Diseases

CTTI Project: State of Clinical Trials

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

in Therapeutic Innovation & Regulatory Science

CTTI Project: Safety Reporting

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

in AnnalsATS

CTTI Project: State of Clinical Trials

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

in PLoS ONE

CTTI Project: State of Clinical Trials

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

in Otolaryngology -- Head and Neck Surgery

CTTI Project: State of Clinical Trials

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

in JAHA

CTTI Project: State of Clinical Trials

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

in Clinical Trials

CTTI Project: Single IRB

Participants’ Perspectives on Safety Monitoring in Clinical Trials

in Clinical Trials

CTTI Project: Safety Reporting

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

in JAMA Internal Medicine

CTTI Project: State of Clinical Trials

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

in Diabetologia

CTTI Project: State of Clinical Trials

Using Central IRBs for Multicenter Clinical Trials in the United States

in PLoS ONE

CTTI Project: Single IRB

Cycle Time Metrics for Multisite Clinical Trials in the United States

in Therapeutic Innovation & Regulatory Science

CTTI Project: Site Metrics

Clinical Trials: Rethinking How We Ensure Quality

in Drug Information Journal

CTTI Project: Quality by Design

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

in Pediatrics

CTTI Project: State of Clinical Trials

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

in JAMA

CTTI Project: State of Clinical Trials

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

in PLoS ONE

CTTI Project: State of Clinical Trials

*The Editorial Board of the 2013 IMIA Yearbook of Medical Informatics lists this publication as one of the best papers published in 2012 in the Clinical Research Informatics subfield of Medical Informatics

Impediments to Clinical Research in the United States

in Clinical Pharmacology & Therapeutics

CTTI Project: State of Clinical Trials

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

in Clinical Trials

CTTI Project: Quality by Design

The Clinical Trials Transformation Initiative (CTTI)

in Annali dell'Istituto Superiore di Sanità

CTTI Project: State of Clinical Trials

The ClinicalTrials.gov Results Database - Update and Key Issues

in The New England Journal of Medicine

CTTI Project: State of Clinical Trials

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

in Monitor

CTTI Project: State of Clinical Trials

The Monitor was a private ACRP publication and this article is not publicly available at this time.

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

in Annals of Internal Medicine

CTTI Project: State of Clinical Trials