title: Is clinical trial registration for simulation-based research necessary?
abstract: Summary statement: The International Committee of Medical Journal Editors requires that all clinical trials be prospectively registered before being considered for publication in their member journals. Clinical trial registries are Web-based databases of clinical trials, providing researchers, journal editors, and reviewers detailed study information to help inform trial results. What is unclear is whether clinical trial registration is required for simulation-based studies, where typically health care providers are the subjects and where the outcomes may be provider based or patient based. In this article, we describe the background and reasoning behind clinical trial registration and discuss whether simulation-based studies should be registered as a prerequisite to publication.
authors.affiliation: From the KidSIM-ASPIRE Simulation Research Program (A.C.), Department of Pediatrics, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada; and Center for Medical Simulation (D.B.R.), Department of Anaesthesia, Critical Care, and Pain Medicine (D.B.R.), Massachusetts General Hospital; and Department of Anaesthesia (D.B.R.), Harvard Medical School, Boston, MA.
authors.forename: Adam
authors.initials: A
authors.lastname: Cheng
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Raemer
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D019992:Databases as Topic; D035081:Editorial Policies; D006801:Humans; D016544:Patient Simulation; D010506:Periodicals as Topic; D011643:Publishing; D012042:Registries