Expert Meetings

2026 CTTI Patient Summit

Posted on by Hannah Faulkner

April 28, 2026

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

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.

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.

Scientific and Technological Issues Surrounding the Use of Mobile Devices in Clinical Trials

JUNE 15, 2017 TO JUNE 16, 2017

CTTI Project: Digital Health Trials

Meeting Objectives

  • Present findings from evidence gathering activities
  • Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile devices for objective data capture in clinical trials. Specifically,
    • possible solutions to key data challenges
    • scientific and technological considerations
  • Identify the change agents who will drive adoption of mobile devices for capturing objective data in clinical trials, including for the purposes of regulatory submission
  • Describe what products CTTI should develop to equip change agents to include mobile devices for data capture in clinical trials, including for the purposes of regulatory submission

Meeting Location:

DoubleTree by Hilton Hotel Crystal City 300 Army Navy Drive | Arlington, VA

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

1. The CTTI MCT Mobile Devices Project and Meeting Goals by Jennifer Goldsack
2. Human Adaptation to Information: A Challenge for the Next Decade by Robert Califf
3. Mobile Clinical Trials and CDRH's Regulation of Devices by Dharmesh Patel
4. Recommendations from CTTI’s MCT Novel Endpoints Project by Jennifer Goldsack
5. Presentation of Evidence on Data Challenges (Panel Presentation)
6. Presentation of Evidence on Scientific and Technological Issues (Panel Presentation)

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.

Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials

NOVEMBER 12, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The goal of this meeting is to seek practical solutions to streamline the operational processes and build efficiencies for data collection in HABP/VABP trials.

Meeting Location:

Arlington, Virginia

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

  • Introduction by Pamela Tenaerts

Session 1: Challenges in data collection for HABP/VABP trials

Session 1 Goal: Understanding the issues surrounding data collection in HABP/VABP trials

Session 1 Focus: Why reducing excessive non-critical data collection in HABP/VABP trials would improve data quality, and benefit investigators, sponsors, reviewers, and patients

Session 2: Regulatory requirements for AE data collection in registration trials

Session 2 Goal: Discuss different regulatory requirements and the challenges of meeting these requirements for data collection for HABP/VABP registration trials that are globally conducted, and evaluate whether future work is needed to harmonize approach to AE collection

Session 2 Focus: AE collection and adjudication of relatedness and seriousness; Reporting of SAE’s and SUSARS and evaluation

Session 3: Strategies to simplify data collection using a QbD approach

Session 3 Goal: To simplify the recording, monitoring, and review to make HABP/VABP trials more feasible and economical

Session 3 Focus: Reduction in the amount of data collected by identifying data that are critical to quality and those that may be essential to determine the benefit/risk of the treatment for registration, and those may be less informative

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.