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Related Experiment Videos

Biomarker method validation in anticancer drug development.

J Cummings1, T H Ward, A Greystoke

  • 1Clinical and Experimental Pharmacology, Paterson Institute for Cancer Research, University of Manchester, Manchester, UK. jcummings@picr.man.ac.uk

British Journal of Pharmacology
|September 19, 2007
PubMed
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Biomarker assay validation is crucial for anticancer drug development and clinical trials in Europe. This review discusses current thinking on validation, emphasizing a fit-for-purpose approach tailored to assay type and quantitation level.

Area of Science:

  • Biomarker discovery and development
  • Clinical trial methodology
  • Assay validation principles

Background:

  • Biomarkers are increasingly vital in anticancer drug development, from early research to clinical surrogate endpoints.
  • European Clinical Trials Regulations apply to labs measuring biomarkers in trials, necessitating robust quality assurance and assay validation.
  • Current regulations lack specificity for research labs, highlighting the need for clear validation guidelines.

Purpose of the Study:

  • To review current thinking on biomarker assay validation for clinical trials.
  • To discuss a 'fit for purpose' approach to validation, considering assay type and quantitation.
  • To provide examples illustrating validation principles for protein biomarkers and cell death assays.

Main Methods:

Related Experiment Videos

  • Discussion of current principles in biomarker assay validation.
  • Categorization of biomarker assays into five types based on quantitation.
  • Case studies: absolute quantitation of protein biomarkers via mass spectrometry and M30/M65 ELISA assays for cell death.

Main Results:

  • Validation strategies must align with the biomarker's role (research vs. clinical endpoint) and quantitation level.
  • A staged, 'fit for purpose' validation approach is recommended over rigid adherence to guidelines.
  • Mass spectrometry and ELISA assays serve as examples for validating different biomarker types.

Conclusions:

  • Biomarker assay validation is essential for reliable data in drug development and clinical trials.
  • A flexible, stage-based validation strategy ensures assays are appropriate for their intended use.
  • Adoption of these principles enhances the quality and utility of biomarker data in oncology research.