CLICK HERE for a list of meeting participants.
CLICK HERE for the meeting agenda.
CLICK HERE for the Executive Summary.
CLICK HERE for the detailed, general summary.

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 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 Management by 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.