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    Adaptive Trial Design

    Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Adaptive designs include group sequential, sample-size re-estimation, response-adaptive randomization, and adaptive enrichment. Modifications must be pre-specified to preserve Type I error and trial integrity.

    What this means in practice

    FDA actively encourages well-designed adaptive trials, especially in rare-disease and breakthrough device contexts.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    FDA·2NIH·1
    1. 1
      FDA Adaptive Designs Guidance
      Needs review
      FDAfda.gov
    2. 2
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov
    3. 3
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov

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