Original Articles

Journal of General Internal Medicine

, Volume 17, Issue 9, pp 689-695

First online:

Physicians’ preferences for active-controlled versus placebo-controlled trials of new antihypertensive drugs

  • Scott D. HalpernAffiliated withCenter for Clinical Epidemiology and BiostatisticsCenter for BioethicsCenter for Education and Research on Therapeutics Email author 
  • , Peter A. UbelAffiliated withLeonard Davis Institute of Health EconomicsAnn Arbor Veterans Affairs Medical Center, University of Michigan School of MedicineDivision of General Internal Medicine, University of Michigan School of Medicine
  • , Jesse A. BerlinAffiliated withCenter for Clinical Epidemiology and BiostatisticsCenter for Education and Research on Therapeutics
  • , Raymond R. TownsendAffiliated withDepartment of Medicine, University of Pennsylvania School of Medicine
  • , David A. AschAffiliated withCenter for Clinical Epidemiology and BiostatisticsCenter for BioethicsLeonard Davis Institute of Health Economicsthe Center for Health Equity Research and Promotion, Philadelphia Veterans Affairs Medical Center

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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