Control treatments in biologics trials of rheumatoid arthritis were often not deemed acceptable in the context of care (original) (raw)

Journal of Clinical Epidemiology, 2015

Abstract

Control treatments in randomized controlled trials (RCTs) should not deliberately disadvantage patients. To compare (a) willingness to include versus (b) willingness to prescribe control treatment among physicians randomized to assess, respectively, either (a) enrollment in a trial or (b) appropriateness of control treatment in a care context for the same fictional patient. Physicians were authors of articles about rheumatoid arthritis (RA), involved in RA patient care and used to enrolling patients in trials. Willingness to give control treatment: trial enrollment or control-treatment appropriateness in care context. We derived 3 case vignettes of fictional standard eligible patients for each of 30 RCTs assessing biologics in RA. Physicians were randomly allocated to the "trial" or "care" arm. For each of the 90 fictional patients, physicians assigned to the trial arm were asked if they would enroll the patient in the RCT the patient was derived from. For the same 90 fictional patients, physicians assigned to the care arm were asked if the control treatment of the RCT was appropriate in a context of usual care. Of the 1,779 physicians invited to participate, 151 were randomized. Half of the fictional patients (41/90; 45% [95%CI 37-53%]) would be enrolled in the RCT even though the control-arm treatment of the RCT was not considered appropriate for them in the context of care. This rate differed by type of comparator (55% for non-head-to-head RCTs vs 6% for head-to-head RCTs; adjusted OR (aOR) 23.9 [95%CI 5.5-92.7]) and duration of trial control treatment (56% for ≤ 24 weeks and 15% for > 24 weeks; aOR 10.7 [95%CI 2.8-63.9]) but not patient RA activity (aOR 2.5 [95%CI 1.0-6.6]). Fictional patients, RA only. Control treatments in RCTs of biologics in RA are often deemed not acceptable in the context of usual care, especially those for non-head-to-head RCTs. These findings raise ethical concerns and challenge the choice of the comparator in RCTs.

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