On coenrollment in clinical resuscitation studies: review and experience from randomized trials.
BACKGROUND
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.
Nichol
G
G
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
Powell
J L
JL
Emerson
S
S
D016887:Cardiopulmonary Resuscitation / Q000379:methods* / Q000401:mortality; D003422:Critical Care / Q000379:methods; D016638:Critical Illness / Q000401:mortality / Q000628:therapy; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D007258:Informed Consent; D007362:Intensive Care Units; D008297:Male; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D014481:United States