Recommendations and Resources

Expert Meetings

Filter Categories
  • All
  • Case Study
  • Recommendation
  • Resource

The Feinstein Institutes for Medical Research at Northwell Improves Investigator Communication through Establishment of Central Office

The Feinstein Institutes for Medical Research at Northwell Health applies CTTI’s Investigator Qualification recommendations

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Case StudyInvestigator Qualification

Recommendations for Decentralized Clinical Trials

Solutions for designing and conducting a decentralized clinical trial

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Recommendation

Figure: Data Availability for FDA Inspection

A figure summarizing the data and supportive information CTTI recommends be made available to FDA inspectors

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Interacting with RegulatorsResource

Table: CTTI Recommended Strategies for Optimizing Data Quality

A table outlining CTTI recommended strategies for optimizing data quality at the point of collection when using a digital health technology

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataResource

Table: Promoting & Protecting Data Integrity

A table outlining CTTI recommended strategies for promoting and protecting data integrity

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataResource

Table: Approaches for Safety Monitoring & Managing Safety Signals when using Digital Health Technologies for Data Capture

A table listing approaches for managing atypical data, including those data captured outside of the intended use of a digital health technology

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataResource

Components of QbD Adoption

A slide outlining the key components of adopting a QbD approach

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Quality By DesignResource

Setting Expectations

A list of tips for implementing a QbD process within your organization

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Quality By DesignResource

Recommendations for Planning for Successful Trial Recruitment

Solutions for moving recruitment planning upstream and parallel to the clinical trial design process to ensure a successful trial

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
RecommendationRecruitment

Decision Tree: Optimizing Your Protocol Design

A decision tool for engaging stakeholders in study design and development

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
RecruitmentResource

How to Monitor Recruitment Process and Performance

A tool to assist in considering how to monitor recruitment process and performance

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
RecruitmentResource

How to Identify and Prioritize Trial Stakeholders

An editable chart that trial designers can use to identify and prioritize the stakeholders they may need to engage to ensure a successful trial

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
RecruitmentResource

Recommendations for Registry Trials

Solutions for assessing and designing registries so that the data meets expectations for FDA review of new products

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
RecommendationRegistry Trials

Framework: Specifications to Consider During Digital Health Technology Selection

A resource highlighting specifications that sponsors should consider during digital health technology selection for each specific trial

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Digital Health TrialsResourceSelecting and Testing Digital Health Technology

Decision Support Tool: Real-Time Data Sharing with Study Participants

A decision tool for trial designers, working with patients, to determine whether outcomes data should be shared with study participants in real-time via a digital health technology

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataResource

Case Study: Feasibility Testing to Promote Successful Inclusion of Digital Health Technologies for Data Capture

An example showing a feasibility study with a cross-over design to support the appropriate selection of digital health technologies for data capture

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSelecting and Testing Digital Health TechnologyTesting a Digital Health Technology

Case Study: Optimizing Data Quality and Participant Privacy

An example detailing an exploratory observational study to collect a variety of digital data from approximately 150 participants

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataResource

Considerations to Support Communication between Institutions and Outside IRBs when Responsibilities are Being Assigned for Multicenter Clinical Trial Protocols

A discussion tool outlining categories of legal and ethical responsibilities of an institution and an IRB in overseeing the conduct of clinical trials in a sIRB model

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSingle IRB

Digital Health Technologies Data Flow Diagram

A diagram outlining the typical passage(s) of data from its collection by a digital health technology through to the composite analysis dataset

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataResource

Quality by Design Metrics Framework

A framework for CROs to identify measures that quantify the outcomes of QbD implementation and guide continuous improvement efforts

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Quality By DesignResource

Quality by Design Maturity Model

A tool for research organizations to assess their current implementation of QbD for clinical trials and to identify a desired future state

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Designed with Quality ApproachQuality By DesignResource

Quality by Design Documentation Tool

A tool for study teams to capture and communicate decisions about what is critical to quality and how the most important risks will be proactively addressed

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Quality By DesignResource

Planning RWD-Supported Recruitment Strategies

A resource for planning a successful and patient-centric RWD-supported recruitment approach

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Real World DataResource

Evaluating Feasibility of RWD-Supported Recruitment

A checklist for discussing eligibility criteria over the course of designing a trial

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Real World DataResource

Single IRB: Institutional Engagement Scenarios

Scenarios that illustrate examples of institutional involvement in research that would be considered engaged, as well as not engaged

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSingle IRB

Single IRB: Institutional Engagement Definitions

A list of engagement terms and definitions used in CTTI’s sIRB recommendations

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSingle IRB

Informed Consent Discussion Tool

A documentation tool for conducting the informed consent process

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Informed ConsentResource

Informed Consent Training Resources

A documentation tool for informed consent trainings

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Informed ConsentResource

Sample Tiered Informed Consent Model

An example outlining the basic structure of a tiered informed consent model

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Informed ConsentResource

Recommendations for Informed Consent

Solutions for conducting the informed consent process and training

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Informed ConsentRecommendation

Single IRB: Resource of Resources Document

A list of educational resources, templates, and tools to facilitate the use of a sIRB for multicenter clinical trials

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSingle IRB

Evaluation Framework for the NIH Single IRB Policy

CTTI’s recommendations to the NIH on its sIRB Policy evaluation framework

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSingle IRB

Use of Single IRBs for Multicenter Clinical Trials Evaluation Checklist

A checklist for evaluating an institutional self-evaluation, an institution/sponsor evaluation of an sIRB, and an sIRB evaluation of an institution

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSingle IRB

CTTI Novel Endpoints Launch Webinar Slides

CTTI Novel Endpoints Launch Webinar Slides...

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Novel EndpointsResource

Case Study: Using Central Labs in Master Protocol Trials

A case study on ALCHEMIST, a set of randomized clinical trials operating under an overarching master protocol sponsored by the
Nation Cancer Institute.

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Master Protocol StudiesResource

Master Protocol Content Development Guide

A guide for developing the written content of a master protocol and sub-protocols

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Master Protocol StudiesResource

Master Protocol References & Resources

A list of references and resources for learning about the concepts of master protocol, adaptive platform trials, basket trials, emerging best practices, and regulatory guidance related to master protocols

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Master Protocol StudiesResource

Master Protocol Studies: Emerging Best Practices to Drive Multi-Stakeholder Collaboration & Mobilization

Four emerging best practices, and correlating CTTI resources, for driving multi-stakeholder collaboration and mobilization during a master protocol study

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Master Protocol StudiesResource

Master Protocol FDA Engagement Tool

A tool sponsors can use to help interact with FDA during the pre-planning and planning stages of a master protocol development

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Master Protocol StudiesResource

Master Protocol Value Proposition Guide

A document outlining key scientifc, operational, and funding considerations that can support early adopters’ efforts to think through the “why” and “how” of developing a master protocol study

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Master Protocol StudiesResource

Master Protocols Operations Partner Assessment

A tool that helps sponsors and operations partners to best prepare for executing core operations functions within the master protocol trial

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Master Protocol StudiesResource

Pregnancy Testing Outcomes Predictor for Clinical Trials

An interactive tool that helps investigators, sponsors, regulators, and others in designing a pregnancy testing plan for a clinical trial by estimating the likelihood of a woman enrolling in the study while pregnant, or becoming pregnant during the study.

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Pregnancy TestingResource

Feasibility Studies Database

A repository of feasibility studies using digital health technologies to capture data in clinical trials that helps researchers to better match appropriate technologies to their trial goals

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceSelecting and Testing Digital Health TechnologyTesting a Digital Health Technology

Digital Health Trials: Recommendations for Delivering an Investigational Product

Recommendations for properly assessing the landscape of applicable laws to take the appropriate steps needed to deliver an intervention to digital health trial participants.

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Delivering an Investigational ProductRecommendation

Digital Health Trials: Recommendations for Managing Data

Recommendations for understanding, planning for, and addressing the new challenges associated with using digital health technologies in clinical trials

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataRecommendation

AACT Database

A publicly available relational database that contains all information (protocol and result data elements) about every study registered in ClinicalTrials.gov.

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
ResourceState of Clinical Trials

Case Study: University of Oxford CTSU

Case Study: University of Oxford CTSU...

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Quality By DesignResource

Philips Offers Best Practices for Inclusion of Digital Health Technologies in Trials, Leading to Better-Prepared Sites and Improved Data Outcomes

Philips Offers Best Practices for Inclusion of Digital Health Technologies in Trials, Leading to Better-Prepared Sites and Improved Data Outcomes...

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Case StudySelecting and Testing Digital Health TechnologyTesting a Digital Health Technology

Digital Health Trials: Recommendations for Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials

Updated recommendations focused on driving novel endpoint use by sponsors and review by regulators for greater acceptance across the clinical trial enterprise

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Developing Novel EndpointsLeveraging All DataRecommendation

Preparing a Digitally-derived Endpoint for Key Endpoint Use

A resource providing sponsors, academics, and operational partners (e.g., technology companies) with
evidentiary considerations to prepare a digitally-derived endpoint for a pivotal trial

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Developing Novel EndpointsLeveraging All DataResource

CTTI Considerations for Advancing the Use of Digital Technologies for Data Capture & Improved Clinical Trials

A resource of considerations for using digital technologies in clinical trials that aligns with CTTI’s Digital Health Trials Program.

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Managing DataResourceSelecting and Testing Digital Health Technology

Randomized, Embedded, Multifactorial Adaptive Platform Trial Case Example: Evaluating Treatment Options for Community-Acquired Pneumonia

A resource providing a case example of embedding clinical trial elements into clinical practice.

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Fully IntegratedResourceTrials in Clinical Practice

From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints

From Ideas to Implementation: ETH Zurich Helps Researchers Leverage Digital Innovation to Build Actionable Endpoints...

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Case StudyDeveloping Novel EndpointsManaging DataSelecting and Testing Digital Health Technology

Increasing Diversity in Clinical Trials

Increasing Diversity in Clinical Trials...

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
DiversityRecommendation

Bristol Myers Squibb (BMS) Co-Hosts Quality by Design Workshop with CTTI to Achieve Quality Culture Aligned with ICH E8(R1)

Bristol Myers Squibb (BMS) Co-Hosts Quality by Design Workshop with CTTI to Achieve Quality Culture Aligned with ICH E8(R1)...

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Case StudyDesigned with Quality ApproachQuality By Design

FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers

FPWR’s Questionnaire Measures Important – But Often Overlooked – Concerns for Prader-Willi Patients and Caregivers...

Resource
Recommendation
Case Study
Recommendations Summary
Quality
Patient Engagement
Investigators and Sites
Digital Health Trials
Novel Clinical Trial Designs
Antibacterial Drug Development
Ethics and Human Research Protection
Case StudyDeveloping Novel EndpointsPatient Group EngagementQuality By Design