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Perspectives on statistical strategies for the regulatory biomarker qualification process
Suzanne B Hendrix1, Robin Mogg2, Sue Jane Wang3
1Pentara Corporation, UT 84109, USA.
Biomarkers in Medicine
|May 26, 2021
Summary
Biomarker qualification needs a statistical strategy to align evidence with its intended use, identify data gaps, and plan research. This framework aids researchers in organizing data and evaluating evidence for biomarker qualification.
Area of Science:
- Biostatistics
- Biomarker Development
- Regulatory Science
Background:
- Biomarker qualification is crucial for medical product development, ensuring reliable use in clinical trials and diagnostics.
- Existing approaches often lack a structured statistical framework for evaluating the evidence supporting a biomarker's intended use.
- A clear statistical strategy is needed to bridge the gap between available data and the requirements for biomarker qualification.
Purpose of the Study:
- To outline a step-by-step statistical strategy for biomarker qualification.
- To provide a framework for assessing evidence and identifying data gaps for biomarker qualification.
- To guide researchers in organizing data and evaluating evidentiary criteria for specific biomarker contexts of use (COU).
Main Methods:
- Detailed step-by-step procedural outline for accumulating, interpreting, and analyzing biomarker data.
- Illustrative examples of a qualified enrichment biomarker and a safety biomarker undergoing qualification.
- Statistical perspective on evaluating evidentiary criteria, paralleling clinical considerations.
Main Results:
- A structured approach to biomarker qualification is presented, emphasizing statistical rigor.
- The framework facilitates the identification of necessary data and research to support qualification.
- Examples demonstrate the practical application of the statistical strategy for different biomarker types.
Conclusions:
- The proposed statistical strategy provides a robust framework for biomarker qualification.
- This approach aids in organizing evidence, identifying gaps, and planning research for biomarker approval.
- It supports regulatory decision-making by providing a clear statistical perspective on biomarker evidence.
Keywords:
analysis plancontext of usediagnosisenrichmentprognosisqualificationrisk/benefitsafetystatisticalvalidationMore Related Videos
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