CTTI

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

SHARE TO:

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:

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

2026 CTTI Patient Summit May 29, 2026
Assessing U.S. Clinical Trials Site Capacity and Readiness for Public Health Emergencies August 13, 2025
The State of Clinical Trials: Charting the Path to 2030 June 17, 2025
Optimizing Data Quality and Flexibility in Clinical Trials Expert Meeting February 28, 2025
Use of Central IRBs for Multi-center Clinical Trials October 10, 2024
Workshop on Quality Risk Management: Making Clinical Trials Fit for Purpose October 10, 2024
Workshop on Quality Risk Management: Understanding What Matters October 10, 2024

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 Agenda

Detailed, General Summary

Meeting Presentations:

Introduction to the Clinical Trials Transformation Initiative (CTTI) by Judith M. Kramer
Origin of the Project, "Use of Central IRBs for Multi-center Clinical Trials" by Jane Perlmutter*
Results of Literature Review by Devon Check*
Early Interviews with Experts by Kathryn Flynn*
Interviews to Obtain Feedback on Proposed Solutions - Rational for "Considerations Document" by Kevin Weinfurt*

*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

Meeting Presentations:

WELCOMING REMARKS

Introduction by Robert J. Temple

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

Monitoring Workstream #3 Key Findings by Briggs Morrison
Learning from Quality by Design in the Manufacturing Sector by Fergus Sweeney
Principles of Quality Risk Managementby Beat Widler

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

Regulatory Agencies and Quality in Clinical Trials Risk Adaptive Approach by Kathleen Meeley
Regulatory Agencies and Quality in Clinical Trials by Pierre Henri Bertoye
What we can do to Ensure the Quality by Tomoko Osawa
CDER Perspective: Challenges in Clinical Trials and the Path Forward by Ann Meeker-O'Connell

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

Building Quality into Clinical Development: The Academic Perspective

Quality in clinical trials: What really matters? by Rory Collins
Building Quality into Clinical Development: ASCEND-HF as a Case Example by Adrian Hernandez and Craig Reist

Building Quality into Clinical Development: The Pharmaceutical Industry Perspective

Building Quality into Clinical Trials – A Pilot with the FDA by David Nickerson
Medical Quality by Design: The Journey Continues by Jeff Kasher
Workshop on Quality Risk Management Making Trials Fit for Purpose by Andrew Lee
Facilitated Clinical Reviews – An Approach For Better Quality Protocols by Craig Wozniak
Risk Based Approach – Case Study by Andy Lawton
Clinical Trial Quality by Design Case Study − A Small Company Experience by Lynn Seely

Building Quality into Clinical Development: Outsourcing

CRO Point of View by Regina Freunscht
Building Quality into Clinical Development: Outsourcing by Ken Getz

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:

Principles Document

Meeting Presentations:

Introduction by Pamela Tenaerts

SESSION I: Landscape, Rationale And Principles

Quality Risk Assessment and Quality by Design in Clinical Research by Martin Landray
How US Regulatory Requirements Contribute to Study Quality by James Saviola
European Perspective on Quality by Angeles Alonso Garcia
Current issues in device development and approval – Industry perspective by Ted Lystig
Current issues in device development and approval – Academic perspective by Laura Mauri
Payor perspective on quality by Louis Jacques

SESSION II: Real‐World Examples

CoreValve U.S. Pivotal Trial by Ted Lystig
TASTE: Thrombus aspiration during ST-‐segment elevation myocardial infarction - A multi-center, prospective, registry based randomized clinical trial by Roxana Mehran
SAFE-PCI: The Study of Access Site for Enhancement of Percutaneous Coronary Intervention for Women by Sunil Rao

SESSION III: Providing Guidance

Principles Document Review by Ann Meeker-O’Connell

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.

The Use of Antibacterial Drugs Developed via Streamlined Approaches for Serious Infections Where There is Unmet Need: Understanding Patient and Physician Perspectives and Considerations to Take Forward

MARCH 01, 2016

CTTI Project: Unmet Need

Meeting Objectives

Present perspectives from patients, caregivers and physicians on antibacterial drugs developed using streamlined approaches
Identify focus group themes and discuss topics which should be further explored or where draft recommendations could be made
Obtain feedback to improve labeling, risk communication, public understanding and stewardship

Meeting Location:

Sheraton Silver Spring Hotel, Silver Spring, MD

Meeting Materials:

Meeting Presentations:

Introduction to the Clinical Trials Transformation Initiative and the ABDD Program by Pamela Tenaerts
Project Overview and Scope by Jamie Roberts
Current Landscape and Pipeline of Antibacterial Products by Vance Fowler
Streamlined Development Approaches by Joseph Toerner
Findings: Perspectives of Patients, Caregivers and Healthy People by Diane Bloom
Findings: Perspectives of Providers and Investigators by Thomas Holland
Focus Group Themes and Questions for Consideration by Stephen Mikita
Closing by Pamela Tenaerts, Rosemary Tiernan & Jamie Roberts

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.

The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies

JANUARY 13, 2021

CTTI Project: Clinical Trial Issues Related to COVID-19

Meeting Overview:

CTTI hosted The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit on Wed., Jan. 13. The summit, conducted as a webinar and moderated by Pamela Tenaerts, CTTI, included a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; and panel discussions moderated by Ester Krofah, FasterCures, and Mark McClellan, Duke-Margolis Center for Health Policy. The panel focused on solutions related to scaling master protocols, including:

Overcoming barriers to starting up sites
Increasing participants at existing sites
Using the COVID experience to inform our preparedness for future pandemics

The public summit also addressed the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and findings of a pre-summit survey that offered best practices and insights from those involved in COVID-19 treatment master protocols, specifically those setting up new sites and recruiting participants at existing sites.

This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, a Center of the Milken Institute.

Meeting Location:

Virtual Meeting