G Nichol1, J L Powell, S Emerson. 1. University of Washington-Harborview Center for Prehospital Emergency Care, Department of Medicine and University of Washington Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA 98104, USA. nichol@u.washington.edu
Abstract
CONTEXT: Patients with acute life-threatening illness are candidates for enrollment in multiple trials. Whether patients are enrolled in multiple trials has implications for patient safety, trial enrollment duration, and study validity. OBJECTIVE: We review issues related to coenrollment and propose guidelines for when it should be allowed. RESULTS: There is no regulatory prohibition on coenrollment of patients in more than one study. Randomized trials of interventions for a variety of clinical conditions have allowed coenrollment without any reported deleterious impact on either study. Guidelines for coenrollment are proposed.
CONTEXT: Patients with acute life-threatening illness are candidates for enrollment in multiple trials. Whether patients are enrolled in multiple trials has implications for patient safety, trial enrollment duration, and study validity. OBJECTIVE: We review issues related to coenrollment and propose guidelines for when it should be allowed. RESULTS: There is no regulatory prohibition on coenrollment of patients in more than one study. Randomized trials of interventions for a variety of clinical conditions have allowed coenrollment without any reported deleterious impact on either study. Guidelines for coenrollment are proposed.
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