Answers are grounded in this paper and cite their sources.
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.
No takes yet. Share an insight, caveat, or question.
Yee et al. (2018) studied this question.
Synapse has enriched 10 related papers. Consider them for comparative context: