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The Master Protocol Concept.

Mary W Redman1, Carmen J Allegra2

  • 1Clinical Biostatistics, Clinical Research Division, Lead Statistician, SWOG Lung Committee and Lung-MAP trial; Fred Hutchinson Cancer Research Center, Seattle, WA.

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|October 5, 2015
PubMed
Summary
This summary is machine-generated.

Master Protocols enable efficient testing of targeted cancer therapies by leveraging rapid genomic sequencing. These innovative platforms streamline drug development for precision oncology in specific patient groups.

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Area of Science:

  • Biomedical Technology
  • Genomics
  • Oncology

Background:

  • Genomic sequencing costs and timelines have drastically decreased since 2003.
  • Next-generation sequencing facilitates the advancement of precision oncology.
  • Testing numerous targeted agents requires novel therapeutic platforms.

Purpose of the Study:

  • Introduce the Master Protocol concept for therapeutic development.
  • Discuss the advantages and challenges of Master Protocols.
  • Provide an overview of active and developing Master Protocols.

Main Methods:

  • Description of the Master Protocol design.
  • Focus on the Lung Master Protocol (Lung-MAP study).
  • Review of current Master Protocol initiatives.

Main Results:

  • Master Protocols are designed for efficient testing of targeted agents.
  • These platforms address the need for testing in small patient subpopulations.
  • The Lung-MAP study serves as a detailed example.

Conclusions:

  • Master Protocols represent a significant advancement in oncology drug development.
  • The design offers gains in efficiency and effectiveness for targeted therapies.
  • Further exploration of Master Protocols is warranted for precision medicine.