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The role of adaptive trial designs in drug development

François Curtin1,2,3, Stephane Heritier4

  • 1a Division of Clinical Pharmacology and Toxicology , University of Geneva , Geneva , Switzerland.

Expert Review of Clinical Pharmacology
|April 25, 2017
PubMed
Abstract

Insights

Adaptive trial design offers a flexible approach to clinical trials, speeding up drug development decisions. This method enhances efficiency and is poised to shape the future of pharmaceutical research.

Area of Science:

  • Pharmaceutical Science
  • Clinical Trial Methodology
  • Biostatistics

Background:

  • Drug development is lengthy and expensive.
  • Adaptive trial design introduces flexibility to improve efficiency.
  • Faster decision-making is crucial for new drug development.

Purpose of the Study:

  • To review adaptive trial design methodologies.
  • To present statistical concepts and implementations across clinical trial phases.
  • To discuss regulatory guidance and future prospects.

Main Methods:

  • Review of adaptive design approaches.
  • Explanation of key statistical concepts.
  • Examples from recent clinical trials and regulatory documents.

Main Results:

  • Adaptive trial design accelerates drug development.
  • Methodological approaches and statistical concepts are detailed.
  • Regulatory guidance from US and European authorities is presented.

Conclusions:

  • Adaptive trial design is a rapidly evolving and important approach.
  • Risks, such as type 1 error, are now well-controlled.
  • Adaptive trial design will significantly influence future drug development.
Keywords:
Adaptive trial designclinical trialdrug development phasesinterim analysisregulatory processtype I error

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