The use of research biopsies in clinical trials is commonplace and will likely increase over time with the need to understand tumor immunity in the microenvironment and to identify new targets for precision medicine. Studies conducted on research biopsy specimens can provide important information regarding patient selection, pharmacodynamic effects, and mechanisms of resistance. Given the potential for knowledge gained from research biopsies, we must ask if we are fulfilling our contract with trial participants who consent to undergo these invasive and potentially risky procedures. The assumption underlying the requirement (mandatory) or request (optional) that a patient undergo a procedure with considerable risk is the expectation that the knowledge gained will justify that risk. If investigators and sponsors do not complete and report analyses based on research biopsies, they fail to live up to their end of this ethical contract.
Overman MJ, Ellis LM, Joffe S. Ethics and the Underreporting of Research Biopsy Findings in Clinical Trials. JAMA Oncol. 2018;4(8):1041–1042. doi:10.1001/jamaoncol.2018.1002
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