A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Annemarie Forrest, MPH, MS, RN
Director of Projects
Clinical Trials Transformation Initiative (CTTI), 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.
Case Study: How a Large Pharma Company Integrates QbD into Clinical Development
Julie Dietrich, MS
Director, Clinical Development
Amgen Inc., United States
A Collaborative Approach to Applying QbD in a CV Outcomes Trial: Lessons Learned
Vice President, Quality Assurance
The Medicines Company, United States