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August 2018

Ethics and the Underreporting of Research Biopsy Findings in Clinical Trials

Author Affiliations
  • 1Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston
  • 2Division of Surgery, Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston
  • 3Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Division of Oncology, Children’s Hospital of Philadelphia, Philadelphia
JAMA Oncol. 2018;4(8):1041-1042. doi:10.1001/jamaoncol.2018.1002

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.