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Clinical cancer research today often includes testing the value of biomarkers to direct treatment and for drug development. However, the practical challenges of integration of molecular information into clinical trial protocols are increasingly appreciated. Inherent difficulties include evidence gaps in available biomarker data, a paucity of robust assay methods, and the design of appropriate studies within the constraints of feasible trial operations, and finite resources. Scalable and proportionate approaches are needed to systematically cope with these challenges. Therefore, we assembled international experts from three clinical trials organisations to identify the common challenges and common solutions. We present a practical risk-assessment framework allowing targeting of scarce resources to crucial issues coupled with a library of useful resources and a simple actionable checklist of recommendations. We hope that these practical methods will be useful for running biomarker-driven trials and ultimately help to develop biomarkers that are ready for integration in routine practice.

Original publication

DOI

10.1016/S1470-2045(13)70607-7

Type

Journal article

Journal

Lancet Oncol

Publication Date

04/2014

Volume

15

Pages

e184 - e193

Keywords

Biomarkers, Tumor, Checklist, Clinical Trials as Topic, Consensus, Europe, Humans, National Cancer Institute (U.S.), Neoplasms, Patient Selection, Research Design, Research Support as Topic, Risk Assessment, Risk Factors, Risk Management, Treatment Outcome, United States