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Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review

L A Renfro1, D J Sargent1

  • 1Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, USA.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|February 9, 2017
PubMed

Insights

New clinical trial designs like platform, basket, and umbrella trials enhance efficiency in cancer research. These adaptive approaches address cancer heterogeneity and limited resources for studying targeted therapies across patient subgroups.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Biostatistics

Background:

  • Cancer is increasingly recognized as heterogeneous, with distinct patient subgroups defined by biomarkers and genetics.
  • Traditional clinical trial models face challenges due to limited funding and the need to study numerous targeted agent-and-target combinations efficiently.
  • The shift towards precision medicine necessitates innovative clinical trial methodologies.

Purpose of the Study:

  • To provide an overview of novel clinical trial designs: platform, basket, and umbrella trials.
  • To discuss the motivations, recommended terminology, and examples of these adaptive trial designs.
  • To highlight the challenges associated with implementing these efficient research approaches.

Main Methods:

  • Review of contemporary clinical trial designs including platform, basket, and umbrella trials.
  • Discussion of the operational efficiencies and adaptive strategies inherent in these designs.
  • Analysis of the application of these trials in the context of precision oncology.

Main Results:

  • Platform, basket, and umbrella trials offer enhanced operational efficiency for studying multiple targeted therapies.
  • These designs facilitate parallel investigation of various agent-and-target combinations across diverse cancer subpopulations.
  • The review outlines recommended terminology and provides illustrative examples of trial applications.

Conclusions:

  • Adaptive clinical trial designs are crucial for advancing precision oncology in an era of limited resources.
  • Platform, basket, and umbrella trials represent a paradigm shift towards more efficient cancer research.
  • Successful implementation requires careful consideration of design, terminology, and operational challenges.

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