A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group.
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.
Translational Research, Radiotherapy and Imaging, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium. Electronic address: jacqueline.a.hall@gmail.com.
Jacqueline Anne
JA
Hall
Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Brussels, Belgium; Department of Pathology, GasthuisZusters Antwerp, Wilrijk, Antwerp, Belgium.
Roberto
R
Salgado
Cancer Diagnosis Programme, Division of Cancer Treatment and Diagnosis, US National Cancer Institute, Rockville, MD, USA.
Tracy
T
Lively
Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, Netherlands.
Fred
F
Sweep
Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, UK.
Anna
A
Schuh
D014408:Biomarkers, Tumor / Q000378:metabolism*; D057189:Checklist; D002986:Clinical Trials as Topic / Q000191:economics / Q000379:methods*; D032921:Consensus; D005060:Europe; D006801:Humans; D054547:National Cancer Institute (U.S.) / Q000191:economics; D009369:Neoplasms / Q000378:metabolism* / Q000628:therapy; D018579:Patient Selection; D012107:Research Design; D012109:Research Support as Topic; D018570:Risk Assessment; D012307:Risk Factors; D012308:Risk Management; D016896:Treatment Outcome; D014481:United States
D014408:Biomarkers, Tumor