Data Safety Monitoring Boards: Overview of Structure and Role in Spinal Cord Injury Studies

IF 2.4 Q1 REHABILITATION
Andrew R. Blight, James D. Guest, James Hamer, Jane T.C. Hsieh, Linda Jones, David S.K. Magnuson, Kimberley Pfleeger
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引用次数: 0

Abstract

This paper provides an overview of the history, composition, organization, responsibilities, and regulatory requirements of Data Safety Monitoring Boards (DSMB), with particular reference to the context of clinical trials in spinal cord injury. It is intended to help potential members of such boards and those undertaking the design of new clinical trials to understand the important role of the DSMB in safeguarding the integrity of complex trials, promoting safety, and countering potential bias. An independent DSMB helps to protect research subjects by providing study oversight and serves as an additional step to assure that clinical trials are performed to existing and appropriate standards. The DSMB must meet on a regular schedule, diligently evaluate all the information it receives, and report in a timely and decisive manner. Members must be free of significant conflicts of interest throughout the study and be adequately trained and experienced to serve their roles within the group. DSMB service can be a valuable learning experience and a gratifying opportunity to participate in advancing medicine and helping to maintain and improve the standards of research.
数据安全监测委员会:脊髓损伤研究中的结构和作用概述
本文概述了数据安全监控委员会(DSMB)的历史、组成、组织、职责和监管要求,特别是在脊髓损伤临床试验方面。本文旨在帮助此类委员会的潜在成员和承担新临床试验设计的人员了解 DSMB 在保障复杂试验的完整性、提高安全性和消除潜在偏见方面的重要作用。独立的 DSMB 通过提供研究监督来帮助保护研究对象,同时也是确保临床试验按照现有的适当标准进行的额外步骤。DSMB 必须定期召开会议,认真评估收到的所有信息,并及时果断地提交报告。成员必须在整个研究过程中没有重大利益冲突,并接受过充分的培训,经验丰富,能够胜任小组内的工作。DSMB 服务是一次宝贵的学习经历,也是一次参与医学进步、帮助维持和提高研究标准的令人欣慰的机会。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
3.20
自引率
3.40%
发文量
33
期刊介绍: Now in our 22nd year as the leading interdisciplinary journal of SCI rehabilitation techniques and care. TSCIR is peer-reviewed, practical, and features one key topic per issue. Published topics include: mobility, sexuality, genitourinary, functional assessment, skin care, psychosocial, high tetraplegia, physical activity, pediatric, FES, sci/tbi, electronic medicine, orthotics, secondary conditions, research, aging, legal issues, women & sci, pain, environmental effects, life care planning
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