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  • Opinion
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The ethical use of mandatory research biopsies

Abstract

Increasingly, clinical trials incorporate translational research questions aimed at identifying biomarkers of response or resistance to agents under investigation. Biomarker assays can require tissue samples to be collected through a research biopsy before therapy, during treatment, or at the time of tumor progression. Such biopsy samples will generally not provide a direct benefit to the patient and, given the risks associated with any surgical procedure, ethical concerns have been raised when the participant's enrollment on a clinical trial depends on their consent to undergo a research biopsy. In this Perspectives article, we present the rationale for mandatory research biopsies and offer suggestions for standardization to ensure that high-quality, patient-centered, clinical trials continue to be designed with scientific and ethical rigor.

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All authors contributed to researching the data for the article, discussions of the content, writing the article and editing the manuscript before submission.

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Correspondence to Eric P. Winer.

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All authors receive grant support from Genentech.

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Olson, E., Lin, N., Krop, I. et al. The ethical use of mandatory research biopsies. Nat Rev Clin Oncol 8, 620–625 (2011). https://doi.org/10.1038/nrclinonc.2011.114

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