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Updated: Feb 24, 2026

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Critical Review of Umbrella, Basket, and Platform Designs for Oncology Clinical Trials

Richard Simon1

  • 1R Simon Consulting, Potomac, Maryland.

Clinical Pharmacology and Therapeutics
|August 11, 2017
PubMed

Insights

New companion diagnostics for cancer drugs, based on genomic alterations, are changing clinical trial designs. This review examines novel biomarker-based trial objectives and lessons learned from completed studies.

Area of Science:

  • Oncology
  • Genomics
  • Clinical Pharmacology

Background:

  • The advent of targeted cancer therapies linked to specific oncogene alterations necessitates a re-evaluation of traditional clinical trial frameworks.
  • Companion diagnostics, identifying patients with targetable genomic alterations, are central to precision medicine in oncology.

Purpose of the Study:

  • To critically review innovative clinical trial designs for biomarker-driven cancer drug development.
  • To elucidate the objectives and evaluate the outcomes of novel trial designs in the context of precision oncology.

Main Methods:

  • Systematic review of contemporary clinical trial designs incorporating biomarker strategies.
  • Analysis of completed trials that have implemented these novel designs to assess their practical application and impact.

Main Results:

  • Identified several emerging clinical trial designs tailored for biomarker-based drug development.
  • Evaluation of completed trials revealed insights into the feasibility, efficiency, and challenges associated with these new designs.

Conclusions:

  • The integration of companion diagnostics is fundamentally reshaping cancer drug development paradigms.
  • Further research and adaptation of trial designs are crucial for optimizing the development of targeted cancer therapies.

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