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Adaptive clinical trial designs for simultaneous testing of matched diagnostics and therapeutics

Howard I Scher1, Shelley Fuld Nasso, Eric H Rubin

  • 1Department of Medicine, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College, New York, New York, USA. scherh@mskcc.org

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|November 3, 2011
PubMed

Insights

This study introduces an adaptive phase III clinical trial design to identify patient subpopulations for targeted cancer therapies. This approach enables matched diagnostics and therapeutics, advancing personalized medicine in oncology.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Biomarker Development

Background:

  • Developing targeted anticancer drugs requires predictive biomarkers and matched diagnostics.
  • Current methods face challenges in identifying suitable patient populations for novel therapeutics.
  • Personalized medicine necessitates integrated diagnostic and therapeutic development strategies.

Purpose of the Study:

  • To present a novel adaptive phase III clinical trial design.
  • To enable the identification of target patient populations early in the trial.
  • To facilitate the concurrent evaluation of experimental therapeutics within identified subpopulations.

Main Methods:

  • Utilizing an adaptive design for phase III clinical trials.
  • Incorporating subpopulation analysis within the trial structure.
  • Integrating biomarker and diagnostic development with therapeutic evaluation.

Main Results:

  • The proposed design allows for the identification of a suitable target population during the trial.
  • It enables the efficacy of an experimental therapeutic to be evaluated within this specific population.
  • The adaptive approach streamlines the development of matched diagnostics and therapeutics.

Conclusions:

  • Adaptive phase III trial designs can significantly improve oncology drug development.
  • This methodology supports the advancement of personalized medicine by enabling matched diagnosis and treatment.
  • The proposed design offers a pathway for more efficient development of targeted anticancer therapies.

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