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Session 4: Disclosure of Innovative Trial Designs: Adaptive Designs and Master Protocol
Session Chair(s)
Tabassum "Tab" Y. Hoda
Senior Manager, Clinical Trials Disclosure
Amgen, United States
Awareness of such Innovative Clinical Trial designs and Master Protocols can be complex and are a challenge in operationalizing for disclosure. These are innovative methods, with no definitive guidance on how trial results should be disclosed in registries, while maintaining a balance between transparency and trial integrity. This session will discuss how the recent FDA guidance documents on Adaptive Designs for Clinical Trials and Master Protocols affect clinical trial disclosure, cover definitions of these methods, provide an overview of how these methods can benefit patients and research, and help to address the gaps while gaining insights from the expert speakers.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify types of Innovative Study Designs e.g. Adaptive study designs and Master Protocols
- Discuss the challenges and key principles in guiding decisions in how to disclose innovative design trials to registries
- Assess the operational challenges and considerations in executing Innovative Trial Designs
Speaker(s)
Innovative Clinical Trial Designs and Considerations for Disclosure
Michelle Detry, PhD
Berry Consultants LLC, United States
Director, Adaptive Trial Execution & Senior Statistical Scientist
Registering Master Protocols
Deborah A. Zarin, DrMed, MD
MRCT Center, United States
Faculty, Harvard Medical Center; Program Director
Patient Perspective: Patient Interest in Trials and How These Trials Make Sense to Patients
Deborah Collyar
Patient Advocates In Research (PAIR), United States
President