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Competing Commitments in Clinical Trials

Most discussion about clinical care in clinical trials has concerned whether subjects’ care may be compromised by research procedures. The possibility that clinical researchers might give priority to helping their “patients” even if that required deviating from the imperatives of the research protocol has been largely ignored. We conducted an online survey of clinical researchers—including physicians, research nurses, and other research staff—to assess the ways in which clinical trials may be at risk for compromise due to clinical researchers’ attempting to address the clinical needs of subjects. The survey covered recruitment, clinical management while in the trial, and termination decisions. It produced a 72% response rate, and the results showed significant biases. Almost 64% of respondents thought that researchers should deviate from the protocol to improve subjects’ care. Of the 52% of respondents who worked on a trial that prohibited using a medication that they believed to be in a subject’s best medical interest, over 28% reported giving the restricted medication at least once. Of the 69% of respondents who reported having had a patient ineligible to participate in a trial, but for whom they believed the trial would be beneficial, 22% recruited the patient anyway. And of the 36% who said one of their patients had met termination criteria but seemed to benefit medically from the trial, 9% reported that they kept the subject in the trial. These results show that the scientific validity of clinical trials may be compromised by researchers’ desire to act in subjects’ best medical interests.

Key words/concepts: clinical trials, research integrity, research ethics, scientific validity

Most discussion about clinical care in clinical trials has concerned whether subjects’ care may be compromised by research procedures. The possibility that clinical researchers might give priority to helping their “patients” even if that required deviating from the imperatives of the research protocol has been largely ignored. We conducted an online survey of clinical researchers—including physicians, research nurses, and other research staff—to assess the ways in which clinical trials may be at risk for compromise due to clinical researchers’ attempting to address the clinical needs of subjects. The survey covered recruitment, clinical management while in the trial, and termination decisions. It produced a 72% response rate, and the results showed significant biases. Almost 64% of respondents thought that researchers should deviate from the protocol to improve subjects’ care. Of the 52% of respondents who worked on a trial that prohibited using a medication that they believed to be in a subject’s best medical interest, over 28% reported giving the restricted medication at least once. Of the 69% of respondents who reported having had a patient ineligible to participate in a trial, but for whom they believed the trial would be beneficial, 22% recruited the patient anyway. And of the 36% who said one of their patients had met termination criteria but seemed to benefit medically from the trial, 9% reported that they kept the subject in the trial. These results show that the scientific validity of clinical trials may be compromised by researchers’ desire to act in subjects’ best medical interests.

Key words/concepts: clinical trials, research integrity, research ethics, scientific validity

Charles W. Lidz, Paul S. Appelbaum, Steven Joffe, Karen Albert, Jill Rosenbaum, and Lorna Simon, "Competing Commitments in Clinical Trials," IRB:Ethics & Human Research 31, no. 5 (2009):1-6