• IRB: ETHICS & HUMAN RESEARCH

Presurgical Trials: Ethical Pitfalls of a Novel Research Method

Abstract: Presurgical trials use a novel research design in which cancer patients receive an investigational drug in the interval between their diagnostic biopsy and their surgical resection. Such trials involve administering a drug without therapeutic intent and then measuring the change in a biomarker in the patient’s tissue. This novel design poses special challenges for the protection of human subjects in three areas: weakening of true informed consent due to therapeutic misconception, interference with potentially curative cancer therapy by participation in the trial, and inability to produce generalizable, clinically relevant knowledge to justify the risks human subjects undertake by participating. This article examines the problems that such trials face in these three areas and provides suggestions for managing ethical challenges in the design, monitoring, and implementation of these trials to ensure that research subjects in them are adequately protected.

Key words: presurgical trials, therapeutic misconception, surrogate end point, clinical trials, cancer, surgery