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Related Experiment Videos

CBER's Experience With Adaptive Design Clinical Trials.

Min Lin1, Shiowjen Lee1, Boguang Zhen1

  • 11 Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Therapeutic Innovation & Regulatory Science
|September 19, 2018
PubMed
Summary

Adaptive clinical trials offer flexibility but require careful planning. This review of FDA Center for Biologics Evaluation and Research (CBER) submissions highlights statistical and operational challenges for adaptive design proposals.

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Area of Science:

  • Clinical Trials Methodology
  • Regulatory Science
  • Biostatistics

Background:

  • Adaptive clinical trials allow modifications based on interim data.
  • The FDA's 2010 draft guidance spurred interest in adaptive designs.
  • Regulatory submissions for adaptive trials have increased.

Purpose of the Study:

  • To survey adaptive design trial proposals submitted to CBER (2008-2013).
  • To summarize experiences and identify challenges in reviewing adaptive trials.
  • To provide recommendations for developing effective adaptive trial proposals.

Main Methods:

  • Retrospective survey of adaptive design trial proposals.
  • Analysis of submissions within the FDA's Center for Biologics Evaluation and Research (CBER).
Keywords:
FDAadaptive designbiologicsclinical trialsurvey

Related Experiment Videos

  • Review of statistical and operational issues encountered during evaluation.

    • Main Results:

    • Summary of adaptive design proposals reviewed by CBER.
    • Identification of key statistical and operational challenges.
    • Insights into the practical application of adaptive trial designs.

    Conclusions:

    • Adaptive designs present unique statistical and operational hurdles.
    • Recommendations are provided to improve the submission and review process.
    • The most efficient study design, whether adaptive or traditional, should be prioritized.