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Global Clinical Trial Disclosure and Data Transparency Conference
Session 4: Disclosure of Innovative Trial Designs: Adaptive Designs and Master Protocol
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
Innovative Clinical Trial Designs and Considerations for Disclosure
Michelle Detry, PhD
- Director, Adaptive Trial Execution & Senior Statistical Scientist
- Berry Consultants LLC, United States
Registering Master Protocols
Deborah A. Zarin, DrMed, MD
- Faculty, Harvard Medical Center; Program Director
- MRCT Center, United States
Patient Perspective: Patient Interest in Trials and How These Trials Make Sense to Patients
- Patient Advocates In Research (PAIR), United States
Preconference Short Courses
Check out our 2019 Program!