CTTI Meetings

Workshop on Quality Risk Management: Understanding What Matters

CTTI Project: Quality by Design

Meeting Location

DoubleTree, Bethesda, MD


CLICK HERE for a list of meeting participants.
CLICK HERE for the meeting agenda.
CLICK HERE for the Principles Document.
CLICK HERE for the meeting summary.

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 Presentations*

SESSION I: Landscape, Rationale And Principles

SESSION II: RealWorld 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.