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Adaptive clinical trials and master protocols

Andrew McGarry1, Karl Kieburtz2

  • 1Department of Neurology, Cooper University Healthcare at Rowan University, Camden, NJ, United States.

Handbook of Clinical Neurology
|February 21, 2023
PubMed

Insights

Adaptive clinical trial designs offer greater flexibility and faster safety and efficacy assessments compared to conventional methods. These innovative approaches optimize trial efficiency and data interpretability for medical interventions.

Area of Science:

  • Clinical Trials Methodology
  • Translational Science
  • Drug Development

Background:

  • Randomized, double-blind, placebo-controlled clinical trials are fundamental in medical research.
  • Evolving scientific knowledge necessitates advancements in clinical trial methodologies.
  • Adaptive trial designs represent a significant evolution in clinical trial methodology.

Purpose of the Study:

  • To summarize general designs, advantages, and pitfalls of adaptive clinical trials.
  • To compare adaptive trial designs with conventional clinical trial designs.
  • To review novel seamless designs and master protocols for improving trial efficiency.

Main Methods:

  • Review of adaptive clinical trial designs.
  • Comparison of adaptive and conventional trial designs.
  • Exploration of seamless designs and master protocols.

Main Results:

  • Adaptive designs allow for modifications (e.g., sample size, criteria) based on interim data.
  • These designs can optimize flexibility and expedite safety and efficacy assessments.
  • Seamless designs and master protocols offer potential improvements in trial efficiency and data interpretability.

Conclusions:

  • Adaptive clinical trials enhance the efficiency and flexibility of evaluating medical interventions.
  • Novel approaches like seamless designs and master protocols further optimize clinical trial processes.
  • These advanced methodologies are crucial for accelerating the assessment of new treatments.
Keywords:
Adaptive designsClinical trialsContinual reassessment methodMaster protocolsParkinson's diseaseStatistical hypothesesUmbrella trials

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