66th ISI World Statistics Congress

66th ISI World Statistics Congress

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Embracing the Bayesian Paradigm: Innovations and Challenges in Global Drug Development

Organiser

YY
Dr Ying Yuan

Participants

  • YZ
    Yong Zang     (Chair)

  • IJ
    Ick Hoon Jin     (Presenter/Speaker)
  • Bayesian Methodology to Handle Delayed outcomes in Adaptive Clinical Trials

  • SL
    Dr Suyu Liu     (Presenter/Speaker)
  • Is Repeated Bayesian Interim Analysis Consequence-Free?

  • YY
    Dr Ying Yuan     (Presenter/Speaker)
  • Implementing FDA’s Bayesian Methodology Guidance: Strategies for Calibrating Trial Success Criteria

  • FY
    Prof. Fangrong Yan     (Presenter/Speaker)
  • Considerations for the Application of Bayesian Methods in Confirmatory Clinical Trials

    • Conference

    66th ISI World Statistics Congress

    Proposal Description

    Recently, the U.S. Food and Drug Administration (FDA) released a draft guidance on the Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products. Concurrently, the European Medicines Agency (EMA) issued a Concept Paper addressing key issues in utilizing Bayesian methods for clinical trials and regulatory approval. These coordinated actions by major regulatory bodies signal a major paradigm shift, paving the way for Bayesian frameworks to serve as primary analysis and decision-making tools in drug development.
    This session will explore the critical statistical challenges and emerging opportunities arising from this regulatory transition. To provide a comprehensive perspective, we will assemble a diverse panel of experts from academia, industry, and regulatory sectors across the U.S. and Asia—ensuring robust representation across geographic regions and gender. Speakers will share strategic insights and highlight recent statistical innovations designed to overcome practical hurdles and advance the implementation of Bayesian methodology in modern drug development.

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