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DIA/FDA Advancing Complex Innovative Clinical Trial Designs to Efficiently Deliver Medicines to Patients

Session 2: CID - Master Protocols

Session Chair(s)

Zoran Antonijevic, MSc

Zoran Antonijevic, MSc

  • Vice President, Statistical Consulting
  • Abond CRO Inc., United States
Min Lin, MD, PhD

Min Lin, MD, PhD

  • Statistical Science Director
  • Astrazeneca, United States
Rui (Sammi) Tang

Rui (Sammi) Tang

  • Vice President, Global Head of Biometrics
  • Servier Pharmaceuticals, United States
Master Protocols test multiple therapies in one indication, one therapy for multiple indications, or both. They also allow for discontinuation or addition of treatment arms and the concept known as platform trial. Master Protocols can significantly improve the efficiency of drug development when appropriately designed and implemented. In this session we will discuss how to manage Master Protocols design and implementation complexities. We will present one case study and then follow-up with novel approaches that focus on the confirmatory stage of development.
Learning Objective :

At the conclusion of this session, participants should be able to:

  • Understand essential elements of Master Protocols
  • Recognize opportunities for application of Mater Protocols
  • Understand and apply new approaches and trends in design of Master Protocols

Speaker(s)

James Travis, PhD

Speaker

James Travis, PhD

  • Mathematical Statistician, OB, OTS, CDER
  • FDA, United States
Michael Proschan, PhD

Design and Analysis of Treatment Trials of Ebola Virus Disease

Michael Proschan, PhD

  • Mathematical Statistician
  • NIAID/NIH, United States
Lisa LaVange, PhD

Speaker

Lisa LaVange, PhD

  • Professor and Chair, Department of Biostatistics
  • University of North Carolina At Chapel Hill, United States
Vladimir Dragalin, PhD

Complex Innovative Design for a Basket Trial

Vladimir Dragalin, PhD

  • Vice President, Scientific Fellow
  • Janssen R&D, at Johnson & Johnson, United States
Nora E Carbine

Panelist

Nora E Carbine

  • Georgetown Breast Cancer Advocate
  • Georgetown Lombardi Cancer Center , United States

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Additional Information

Complex Innovative Clinical Trial Designs Resource Kit

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Recent Regulatory Efforts on Complex Innovative Clinical Trial Design
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