Expert Meetings

2026 CTTI Patient Summit

Posted on by Hannah Faulkner

April 28, 2026

On April 28, 2026, patients, caregivers, and advocates gathered for the CTTI Patient Summit to discuss perspectives on the use of AI in clinical trials, the reuse of patient data, and opportunities to strengthen patient engagement in clinical research.

Access the materials below to learn more about the discussions and key themes that emerged during the Summit.

Patient Summit Resources: 

Summit Recordings:

Welcome and Opening Remarks

Fireside Chat: Patient perceptions of the risks of and comfort with the use of AI in clinical trials

Fireside Chat: Perspectives on patient data reuse beyond the original trial

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Recent Expert Meetings

Assessing U.S. Clinical Trials Site Capacity and Readiness for Public Health Emergencies​

July 30-31, 2025

CTTI Project: Watchtower

MEETING OBJECTIVE:

  • Gather perspectives on what information should be included in a framework to assess site capacity and capabilities to support a coordinated response to future public health emergencies.

Meeting Location:

Virtual

Meeting Materials:

Meeting Agenda
Meeting Summary
Presentation Set Day 1
Presentation Set Day 2

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Recent Expert Meetings

The State of Clinical Trials: Charting the Path to 2030

MAY 22, 2025

CTTI Project: State of Clinical Trials

Meeting Objectives:

  • Create shared understanding of how the clinical trials enterprise is performing
  • Advance solutions to catalyze trial efficiency, in line with CTTI’s Transforming Trials 2030 vision
  • Identify individual and collective actions to ensure a thriving trials enterprise moving forward

Meeting Location:

The Westin Downtown Washington, D.C.

Meeting Materials:

Meeting Agenda

List of meeting attendees

Full Presentation Set

Executive Summary

 

The views and opinions expressed in these presentations are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Optimizing Data Quality and Flexibility in Clinical Trials Expert Meeting

February 26, 2025

CTTI Project: Optimizing Data Quality and Flexibility in Clinical Trials

MEETING OBJECTIVES: 

  • Evaluate the benefits and feasibility of offering flexible operational approaches to support participant needs & preferences
  • Discuss how flexible operational approaches might affect data quality
  • Explore solutions for mitigating the errors that matter to data quality

Meeting Location:

Marriott Capitol Hill | Burnham Room
175 L St NE, Washington, D.C.

Meeting Materials:

Meeting Agenda

Meeting Summary

List of meeting attendees

Full Presentation Set

 

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Recent Expert Meetings

Use of Central IRBs for Multi-center Clinical Trials

APRIL 25, 2012 TO APRIL 26, 2012

CTTI Project: Single IRB

Meeting Background:

The willingness of institutions to defer full local institutional review board (IRB) review and approval to a central IRB in multi-center trials continues to vary, despite a 2006 U.S. Food and Drug Administration (FDA) guidance and a more recent endorsement by the U.S. Office for Human Research Protections recommending this approach. The goal of the CTTI project is to identify potential solutions to address barriers to the adoption of central IRBs for multi-center clinical trials.

Meeting Objectives:

  • Present research findings from the CTTI project entitled, Use of Central IRBs for Multi-center Clinical Trials
  • Discuss research findings among experts present at the meeting
  • Solicit additional feedback to refine proposed solutions

Meeting Location:

Hilton Washington DC/Rockville Executive Meeting Center, Rockville, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Workshop on Quality Risk Management: Making Clinical Trials Fit for Purpose

AUGUST 23, 2011 TO AUGUST 24, 2011

CTTI Project: Quality by Design

Meeting Background:

At an expert meeting held in October 2010 for the CTTI monitoring project, representatives from a broad cross-section of the clinical trial enterprise—including regulators, government sponsors of clinical research, academicians, industry representatives, patient advocates, clinical investigators, and other interested parties—discussed clinical trial monitoring as one component of an overall quality framework. Panelists and participants agreed that an enlightened approach to ensuring trial quality is needed. Such an approach would apply risk management principles to clinical trials by prospectively identifying critical trial deliverables and important risks to each and then tailoring protocol design and delivery to mitigate those risks. To implement this change, participants agreed that all stakeholders in the clinical trial process must modify their view of risk and have a common understanding of Quality by Design and quality risk management principles. This workshop is the first in a planned series intended to develop Quality by Design and quality risk management principles applicable broadly to clinical trials and development programs, as well as to identify and share best practices for implementing these principles.

Meeting Objectives:

  • Develop Quality by Design concepts for the clinical trial process
  • Define consensus principles of quality risk management as applied in the drug development lifecycle and in conjunction with Quality by Design concepts
  • Review case studies of Quality by Design and quality risk management approaches applied in commercial and academic clinical trial settings, including tools and methodologies and potential best practices
  • Discuss methods for evaluating the success of Quality by Design and quality risk management approaches in enhancing the quality and efficiency of clinical development
  • Identify mechanisms to disseminate principles and best practices identified during the workshop to a broad array of stakeholders.

Meeting Location:

Hyatt Regency Bethesda, Bethesda, Maryland

Meeting Materials:

Executive Summary

Detailed, General Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

WELCOMING REMARKS

SESSION I: PRINCIPLES FOR BUILDING QUALITY INTO CLINICAL TRIAL DEVELOPMENT
Session Facilitators: Leslie and Peter (lead)

SESSION II: REGULATORS' PANEL
Session Facilitators: Fergus and Leslie (lead)

SESSION III: CASE STUDIES
Session Facilitators: Peter (lead), Fergus, and Ann

Building Quality into Clinical Development: The Academic Perspective

Building Quality into Clinical Development: The Pharmaceutical Industry Perspective

Building Quality into Clinical Development: Outsourcing

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Workshop on Quality Risk Management: Understanding What Matters

JANUARY 29, 2014 TO JANUARY 30, 2014

CTTI Project: Quality by Design

Meeting Background:

This meeting continued the CTTI workshop series, conducted to evaluate, and allow participants to practice, application of Quality by Design (QbD) principles to clinical trials. The January 2014 workshop focused specifically on applying QbD principles in medical device and diagnostic trials.

Quality by Design emphasizes building quality into a process from the beginning. Applied in clinical development, this approach prospectively examines the design and objectives of trials and identifies “critical to quality” factors (e.g. key data and trial processes such as randomization). Understanding what aspects of a trial are “critical to quality” is essential to subsequently identifying and managing important and likely risks to trial quality. These risks can be managed through modifying trial design, tailoring its implementation, and providing sensible, risk-based oversight. These approaches also have the potential to improve clinical trial efficiency. Focusing on critical aspects of a trial could substantially reduce the burden of clinical trial conduct by relieving sponsors of a perceived obligation to mitigate every potential risk posed by a trial, especially for those activities that minimally affect data quality and human subject protection.

Meeting Objectives:

  • Develop understanding of risk-based Quality by Design for clinical trials, from general principles, real-‐world examples, and hypothetical case studies
  • Gain confidence in the application of such concepts to clinical trials
  • Identify obstacles to the adoption of this approach
  • Identify opportunities for dissemination of these principles and practices to a broad array of stakeholders

Meeting Location:

DoubleTree, Bethesda, MD

Meeting Materials:

Meeting Summary

Principles Document

Meeting Agenda

List of meeting attendees

Meeting Presentations:

SESSION I: Landscape, Rationale And Principles

SESSION II: Real‐World Examples

SESSION III: Providing Guidance

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Real-World Data and Evidence in the Evaluation of Medical Products

JUNE 12, 2018 TO JUNE 13, 2018

CTTI Project: Real-World Data

Meeting Scope:

  • Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
  • Real-World Evidence (RWE) is the clinical evidence regarding the usage, and potential benefits and risks, of a medical project derived from analysis of RWD.
  • The focus of this meeting and project is to explore the appropriate use of electronic health records and payment claims (RWD) in randomized clinical trials (RCTs) to generate RWE to support regulatory decision-making.

Meeting Objectives:

  • Present findings from evidence gathering activities.
  • Identify barriers and potential solutions to generating RWE for regulatory submissions from these RWD sources.
  • Describe what recommendations and resources CTTI should develop to equip change agents to increase appropriate use of RWD in RCTs, including to support regulatory submissions.

Meeting Location:

DoubleTree by Hilton Hotel Bethesda-Washington DC 8120 Wisconsin Ave., Bethesda, MD 20814

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Introduction to the Clinical Trials Transformation Initiative (CTTI) by Pamela Tenaerts
  2. Issue, Project Overview, and Meeting Objectives by Gerrit Hamre
  3. Qualitative Interview Findings by Jack Sheehan
  4. Use of RWD in Pre-Study Planning and Study Set Up Session Introduction by Jane Perlmutter
  5. Use of RWD in Pre-Study Planning & Study Set up: Health Plan Perspective by Kevin Haynes
  6. Use of RWD in Pre-Study Planning & Study Set up: Manufacturer Perspective by Ben Gutierrez
  7. Using the Cystic Fibrosis Patient Registry to Support Clinical Trials Planning by Aliza Fink
  8. Use of RWD in Study Recruitment and Enrollment: EHR Enabled Platform by James Hamrick
  9. Patient & Site Identification Using an EMR Data System by David Thompson
  10. Real-World Treatment Responses in Advanced NSCLC Patient Subgroups by Michael Lu
  11. Real World Data Use in Embedded Pragmatic Clinical Trials by Sarah Leatherman
  12. Use of Real-World Data within ADAPTABLE, The Aspirin Study by Brad Hammill
  13. Day One Recap and Discussion of Priority Insights by Khair ElZarrad

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Patient Groups and Clinical Trials Expert Meeting

JANUARY 21, 2015 TO JANUARY 22, 2015

CTTI Project: Patient Group Engagement

Meeting Objectives

  • Define consensus principles of Patient Group engagement from the 3-way (Industry, Patient Group, and Academia) stakeholder perspectives using case studies of success and barriers
  • Share evidence and key findings from a 3-way stakeholder assessment of Patient Group engagement in the Clinical Trial process
  • Gain understanding of the FDA Rules of Engagement and various Conflict of Interest (COI) issues
  • Solicit feedback on evidence to inform recommendations that can further enhance the value to industry, academia and patient groups of mutually beneficial partnerships that engage the patient groups as fully as possible in the complete spectrum of the clinical research enterprise
  • Solicit feedback on benchmarking, metrics, and value of patient engagement in clinical trials for research sponsors

Meeting Location:

Fairmont Hotel, Washington, DC

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

DAY 1 – JANUARY 21 , 2015

DAY 2 – JANUARY 22 , 2015

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Stakeholder Perceptions of the Use of Mobile Technology in Clinical Trials

JANUARY 09, 2018 TO JANUARY 10, 2018

CTTI Project: Digital Health Trials

Meeting Objectives:

  • Present findings from CTTI evidence gathering activities examining the perspectives of investigators and potential research participants on the use of mobile technology for collection of objective data in clinical trials.
  • Discuss how this and additional evidence presented may be used to provide direction to the research enterprise for the appropriate utilization of mobile technology in clinical trials.
  • Identify products that CTTI should develop to equip the clinical trials enterprise to address the barriers, preferences, and needs of investigative site personnel and potential research participants in regulatory submission trials using mobile technology.

Meeting Location:

Hyatt Regency Bethesda 1 Bethesda Metro Center, Bethesda, MD 20814

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  1. Welcome and Background by Annemarie Forrest
  2. Keynote Presentation by John Wilbanks
  3. Findings from the MCT Stakeholder Perceptions Survey of Potential Clinical Trial Participants by Angie Botto-van Bemden, Cindy Geoghegan, and Les Jordan
  4. Key Considerations for Patient Engagement in Clinical Trials by Suzanne Schrandt
  5. Ethical and Privacy Considerations of Mobile Technology by Camille Nebeker
  6. Findings from MCT Stakeholder Perceptions Investigator Interviews by Bill Wood

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.