From the NIH: The Misguided Ethics of Crossover Trials

Contemp Clin Trials. 2013 Dec 20. pii: S1551-7144(13)00200-0. doi: 10.1016/j.cct.2013.12.003. [Epub ahead of print]

The Misguided Ethics of Crossover Trials.

Prasad V¹, Grady C².

Author information

• ¹Medical Oncology Branch, National Cancer Institute, National Institutes of Health, 10 Center Dr. 10/12N226, Bethesda, MD 20892. Electronic address: vinayak.prasad@nih.gov.
• ²Department of Bioethics, National Institutes of Health, 10 Center Dr. 10/1C118, Bethesda MD 20892. Electronic address: CGrady@cc.nih.gov.

Abstract

Crossover is increasingly favored in trials of cancer therapies; even those that seek to establish the basic efficacy of novel drugs. Crossover is done in part for trial recruitment, but also out of a sense of doing the right thing-offering the investigational agent to more patients. In this paper, we argue that this ethical feeling-that crossover is a preferred trial choice-is misguided. In seeking to sate the desires of participants, we might undermine a trial's ability to answer a meaningful clinical question. When a trial is incapable of answering a question, it becomes unethical. Using a crossover strategy in oncology clinical trials can make trials less ethical, not more.