Biomarkers in early-phase trials: fundamental issues. (20th June 2018)

• Record Type: Journal Article
• Authors: Yee, Laura M; Lively, Tracy G; McShane, Lisa M
• Is Part Of: Bioanalysis. Volume 10:Number 12(2018)
• Page Start: 933
• Page End: 944
• Publication Date: 2018-06-20
• Subjects: analytical validation -- biomarkers -- clinical trials -- drug development -- early-phase trials; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2018-0006
• Languages: English
• ISSNs: 1757-6180

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.