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基于模拟的研究是否需要进行临床试验注册?

Is clinical trial registration for simulation-based research necessary?

作者信息

Cheng Adam, Raemer Daniel B

机构信息

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.

出版信息

Simul Healthc. 2014 Dec;9(6):350-2. doi: 10.1097/SIH.0000000000000064.

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.

摘要

总结声明

国际医学期刊编辑委员会要求所有临床试验在考虑在其成员期刊上发表之前进行前瞻性注册。临床试验注册库是基于网络的临床试验数据库,为研究人员、期刊编辑和审稿人提供详细的研究信息,以帮助了解试验结果。尚不清楚的是,对于基于模拟的研究是否需要进行临床试验注册,在这类研究中,通常医疗保健提供者是受试者,结果可能基于提供者或基于患者。在本文中,我们描述了临床试验注册背后的背景和理由,并讨论基于模拟的研究是否应作为发表的先决条件进行注册。

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