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New designs for basket clinical trials in oncology

Richard Simon1

  • 1a R Simon Consulting , Potomac , MD , USA.

Journal of Biopharmaceutical Statistics
|September 7, 2017
PubMed

Insights

Human cancer

Area of Science:

  • Oncology and molecular biology

Background:

  • Human cancers exhibit significant molecular heterogeneity, impacting therapeutic strategies.
  • Current cancer drugs target specific molecular alterations within cancer cells.
  • Tumors from the same primary site can possess distinct molecular profiles.

Purpose of the Study:

  • To review clinical trial designs for co-developing therapeutics and predictive biomarkers.
  • To inform the application of these strategies in oncology.

Main Methods:

  • Review of existing clinical trial designs.
  • Analysis of approaches for integrating therapeutic and biomarker development.

Main Results:

  • Identification of various clinical trial designs suitable for co-development.
  • Demonstration of how predictive biomarkers guide therapeutic use.

Conclusions:

  • Novel clinical trial designs are essential to address cancer's molecular heterogeneity.
  • Co-development of therapeutics and predictive biomarkers represents a key strategy in modern oncology.
Keywords:
Basket designcompanion diagnosticenrichment trialpredictive biomarker

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