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Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest global requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.


Session 4: Disclosure of Innovative Trial Designs: Adaptive Designs and Master Protocol

Session Chair(s)

Tabassum "Tab" Y. Hoda

Tabassum "Tab" Y. Hoda

  • Senior Manager, Clinical Trials Disclosure
  • Amgen, Inc., 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)

Michelle  Detry, PhD

Innovative Clinical Trial Designs and Considerations for Disclosure

Michelle Detry, PhD

  • Director, Adaptive Trial Execution & Senior Statistical Scientist
  • Berry Consultants, United States
Deborah A. Zarin, DrMed, MD

Registering Master Protocols

Deborah A. Zarin, DrMed, MD

  • Faculty, Harvard Medical Center; Program Director
  • MRCT Center, United States
Deborah E. Collyar

Patient Perspective: Patient Interest in Trials and How These Trials Make Sense to Patients

Deborah E. Collyar

  • President
  • Patient Advocates In Research (PAIR), United States