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No consensus found in attitudes, practices regarding off-protocol therapy

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Results from a nationwide survey showed that although most oncologists discussed off-protocol therapies with patients, there was little agreement about actually providing such treatments.

Researchers collected responses from 146 of 471 oncologists who received an anonymous questionnaire. Overall, 93% of respondents reported discussing with their patients the possibility of obtaining investigational therapies outside of clinical trials, and 81% said they had provided such treatment at least once. Two-thirds said they discussed off-trial protocols at least once per year and 12% said they did so at least once per month.

Academic oncologists were more likely to report providing off-trial protocols than community oncologists (89% vs. 75%). Academic oncologists were also more likely to have discussed off-trial protocols at least once per month and five times per year and more likely to have denied a patient’s request for off-trial protocols at least once per month and five times per year.

In general, respondents were opposed to administering investigational therapies outside of a trial setting, with 61% that indicated patients should be discouraged from off-trial protocols. Only 31% felt that such protocols should be forbidden, however.

When asked if informed consent required telling patients they might have the option of obtaining an investigational treatment outside of a clinical trial if that treatment became commercially available, 53% of respondents said yes and 34% said no.

Fifty-six percent indicated that patients who refused to enroll in a clinical trial had no right to off-trial protocols. Only 26% felt those patients should have that right.

The researchers cautioned against drawing conclusions from these results. They suggested the study results were only “descriptive and hypothesis-generating” and cited the 31% response rate. They added, however, that more responses likely would not have led to more uniformity in attitudes and practices.

J Clin Oncol. 2008;doi:10.1200/JCO.2008.18.1420.