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Biomarkers in early-phase trials: fundamental issues
Laura M Yee1, Tracy G Lively1, Lisa M McShane1
1Division of Cancer Treatment & Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, MD, 20850, USA.
Abstract:
Biomarkers are frequently being included in early-phase clinical trials. This article is meant to introduce clinical investigators to the fundamentals of choosing a biomarker test for use in an early phase trial. Steps to consider are briefly outlined including defining the role of the biomarker in the early phase trial; selecting a fit-for-purpose biomarker test and laboratory; describing the test procedures; carrying out analytical validation testing appropriate for the research objectives and the risk involved in the trial; implementing the test in the trial; and planning for the future. Examples illustrate analytical validation approaches in the context of typical biomarker roles. The importance of collaboration between clinical investigators and laboratory researchers is emphasized.
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