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Invited Commentary
Feb 13, 2012

Placebo-Controlled Trials, Ethics, and the Goals of Comparative Effectiveness ResearchComment on “Lack of Head-to-Head Trials and Fair Control Arms”

Author Affiliations

Author Affiliation: Institute for Clinical and Economic Review, Boston, Massachusetts.

Arch Intern Med. 2012;172(3):244-245. doi:10.1001/archinternmed.2011.1715

Despite a push toward comparative effectiveness research, Estellat and Ravaud1 present evidence that the majority of randomized controlled trials of biologic DMARDs continue to compare new agents with placebos rather than approved active medications. Their data are derived from study protocols listed at ClinicalTrials.gov. The authors found that, among randomized controlled trials completed since 2002 or still ongoing, only 5 (5%) of 91 trials involved a head-to-head comparison of DMARDs. The authors draw particular attention to 63 of these trials involving patients with a potentially high level of active disease who had never been treated with any type of DMARD before. Among these trials, 54 (86%) were designed so that control patients received their current “ineffective” treatment alone or with a placebo added. The authors conclude that most current studies of biologic DMARDs expose patients in control arms to long periods of care with placebos, placing them at risk for deterioration of their condition while producing scientific results of questionable usefulness.

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