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A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Session Chair(s)
Annemarie Forrest, MPH, MS, RN
Research Senior Supervisor/Program Manager, University of Michigan, United States
The Clinical Trials Transformation Initiative (CTTI) and the FDA evaluated methods to prospectively build quality into the scientific and operational design of clinical trials (quality by design). Applying the CTTI quality-by-design recommendations and principles permits organizations to prioritize the most critical aspects of a trial’s quality; identify non-essential activities that can be eliminated to streamline trial conduct and oversight; and develop appropriate plans to define, avoid, mitigate, monitor, and address important errors. This session will provide a brief overview of the CTTI project and recommendations and speakers will describe their experience with implementing a quality-by-design approach in clinical trials.
Learning Objective : Identify recommendations and lessons learned from the CTTI quality by design project; Describe strategies for implementing a quality by design approach to trial design and conduct.
Speaker(s)
Julie Dietrich, MS
Senior Director, Clinical Development, United States
Case Study: How a Large Pharma Company Integrates QbD into Clinical Development
Sabrina Comic-Savic, MD, MPH
Vice President, Quality Assurance, Clinical Project Oversight, Novartis, United States
A Collaborative Approach to Applying QbD in a CV Outcomes Trial: Lessons Learned
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