Clinical Decisionmaking

Misconceptions about cancer clinical trials occur often among patients and researchers

Both patients and physician investigators often have misconceptions about cancer clinical trials in which they participate. Efforts are needed to educate them, says Steven Joffe, M.D., of the Dana-Farber Cancer Institute. In a study supported by the Agency for Healthcare Research and Quality (National Research Service Award training grant T32 HS00063), Dr. Joffe and colleagues analyzed responses to a standard questionnaire from 207 adult cancer patients who had recently enrolled in a clinical trial at one of three hospitals. They also surveyed the physician who obtained each patient's consent. On average, physicians spent much time discussing the trial with potential participants, most of whom took several days to consider their participation.

Ninety percent of the cancer patients were satisfied with the informed consent process, and most considered themselves to be well informed about the clinical trial. Yet, many did not recognize nonstandard treatment (74 percent), the potential for incremental risk from participation (63 percent), the unproven nature of the treatment to be the best one for their cancer (70 percent), the uncertainty of benefits to self (29 percent), or that clinical trials are done mainly to benefit future patients (25 percent). Most cancer patients in phase III trials (48 of 53) were aware that they were being randomly assigned to treatment, but fewer phase I participants (22 of 50) knew that their trial involved dose-escalation to assess a medication's toxic effects.

Unfortunately, many physicians shared some of the same misconceptions as participants. For example, only 46 percent of physician/investigators recognized that the main reason for clinical trials is benefit to future patients. After all, many physicians encourage patients to enroll in these trials because they believe a trial offers them the best therapeutic option at that point. Also, up to one-third of providers were uncertain whether clinical trials always use nonstandard treatments or procedures, whether the treatments assessed are by definition unproven, and whether the trials involve some incremental risk or discomfort.

More details are in "Quality of informed consent in cancer clinical trials: A cross-sectional survey," by Dr. Joffe, E. Francis Cook, D.Sc., Paul D. Cleary, Ph.D., and others, in the November 24, 2001 issue of the Lancet 358, pp. 1772-1777.

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