Physicians’ preferences for active-controlled versus placebo-controlled trials of new antihypertensive drugs Authors
Cite this article as: Halpern, S.D., Ubel, P.A., Berlin, J.A. et al. J GEN INTERN MED (2002) 17: 689. doi:10.1046/j.1525-1497.2002.11024.x Abstract OBJECTIVE: To evaluate physicians’ preferences for referring patients to, and using information from, active-controlled trials (ACTs) versus placebo-controlled trials (PCTs) of new antihypertensive drugs. DESIGN AND SETTING: Nationwide mailed survey, with telephone contact of nonresponders to assess nonresponse bias. PARTICIPANTS: One thousand two hundred primary care physicians randomly selected from the American Medical Association’s Master File. Of 1,154 physicians eligible to respond, 651 (56.4%) returned completed questionnaires. MEASUREMENTS AND MAIN RESULTS: We measured physicians’ stated willingness to encourage hypertensive patients to enroll in ACTs and PCTs of new antihypertensive drugs, their views of the relative merits of ACTs versus PCTs, their stated willingness to prescribe new drugs tested in ACTs or PCTs, and their views regarding the overall justifiability of the 2 designs. Physicians were significantly more likely to indicate they would encourage their patients to enroll in ACTs than in PCTs ( P<.0001). Physicians thought ACTs provided more valuable information for their practices, were more likely to lead to a public health benefit, offered enrolled patients greater opportunity for personal benefit, and were less likely to expose enrolled patients to unnecessary risks (all P<.0001). Physicians were more likely to prescribe new drugs that had been compared in ACTs ( P<.0001), and viewed ACTs as a more justifiable method for testing new antihypertensive drugs ( P<.0001). There was no evidence of nonresponse bias for these main results. CONCLUSIONS: Although PCTs remain the standard method for testing new antihypertensive drugs, physicians strongly prefer ACTs. Using ACTs to test new antihypertensive drugs may enhance the efficiency of patient recruitment and more strongly influence physicians’ prescribing practices. Key words clinical trials placebo-controlled trials antihypertensive drugs physicians’ preferences ethics
This work was supported by an unrestricted grant from Merck and Company to the Leonard Davis Institute of Health Economics.
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