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Session 3: The Art of Implementing and Conducting Platform Trials
Session Chair(s)
Michelle A Detry, PHD
Director, Adaptive Trial Execution & Senior Statistical Scientist, Berry Consultants, LLC, United States
Anne-Marie Duliege
Chief Medical Officer, Pancreatic Cancer Action Network, United States
This session will present the main strategic and operational considerations during the preparation and implementation of platform trials. Platform trials require an intense collaboration among numerous groups that differs from the standard clinical trial infrastructure. Their viewpoints must be integrated to meet the common goal of the platform. The speakers will describe their roles in the design and conduct of various ongoing platform trials, as well as some of the challenges they may face.
Learning Objective : - Understand the role of the various partners required to conduct a platform trial, and their contributions to the value of this trial
- Identify the unique perspectives and operational challenges involved in conducting a platform trial
- Understand the importance of an intense collaboration between the partners to address these challenges and contribute to an optimal conduct of a platform trial
Speaker(s)
Meredith Buxton, PHD, MPH
Chief Executive Officer, Global Coalition For Adaptive Research, United States
Identifying the Right Industry Partners: The Role of the Sponsor
Vincent Picozzi
, Virginia Mason Franciscan Health, United States
Advancing the Science: The Perspective of an Investigator
Ewa Carrier, DrMed
Executive Director, Fibrogen, United States
Advancing the Science: Joining a Platform Trial: the Perspective of the Biopharma Partner
Len Rosenberg, PHD, RPH
, United States
Operational Excellence: The Ultimate Collaboration Between the Sponsor and the CRO
Melanie Quintana, PHD
Director & Senior Statistical Scientist, Berry Consultants, LLC, United States
The Critical Role of the Blinded Statistician: Role and Interactions with the FDA
Sabrina Paganoni, MD, PHD
Assistant Professor, Harvard Medical School, Healey Center for ALS at Mass General, United States
Patients as Research Partners
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