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:

• 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