Spitzer Ernest, Fanaroff Alexander C, Gibson C Michael, Seltzer Jonathan, McFadden Eugene, Ali Maria, Wilson Matthew, Menon Venu, Mehran Roxana, Held Claes, Mahaffey Kenneth W, Lopes Renato D
Department of Cardiology and Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands; Cardialysis, Clinical Trial Management and Core Laboratories, Rotterdam, The Netherlands.
Cardiovascular Outcomes Quality and Evaluative Research Center, Leonard Davis Institute for Health Economics, and Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA.
Am Heart J. 2022 Jun;248:120-129. doi: 10.1016/j.ahj.2022.03.005. Epub 2022 Mar 13.
Randomized clinical trials are the gold standard to assess the causal relationship between an intervention and subsequent outcomes, also known as clinical endpoints. In order to limit bias, central clinical events committees (CEC) are established to ensure consistent event reporting across participating centers, as well as complete and accurate ascertainment of endpoints. However, defining independence is challenging.
This consensus statement was generated by teleconferences and electronic communications among clinical research organizations from the United States, Europe and Australia. This document does not constitute regulatory guidance.
An independent CEC is defined when the adjudicators are not primarily involved in designing, funding, sponsoring, organizing, conducting, analyzing or regulating the clinical trial for which they serve as an adjudicator, beyond their role as CEC member. Moreover, independence requires absence of conflicts of interest with the steering committee, sponsor, grant giver, manufacturer, coordinating center, other independent committees, core laboratories, medical monitor, safety physician, participating clinical sites, statistician or data manager, regulatory agencies or authorities, which could influence (or be perceived to influence) a member's objectivity in evaluating trial data. Such conflicts of interest include financial benefits, directing or advisory role (paid or unpaid), decision-making position, as well as being a direct relative. An independent adjudicator has no other role within a clinical trial.
This consensus statement presents a standardized definition of an independent CEC to be considered by clinical research organizations, manufacturers, and investigators. In addition, it provides recommendations on best practices for implementation of an independent CEC.
随机临床试验是评估干预措施与后续结果（即临床终点）之间因果关系的金标准。为了限制偏倚，设立了中央临床事件委员会（CEC），以确保各参与中心的事件报告一致，并确保终点的完整准确判定。然而，定义独立性具有挑战性。
本共识声明由美国、欧洲和澳大利亚的临床研究组织通过电话会议和电子通信生成。本文件不构成监管指南。
当裁决者除作为CEC成员的角色外，不主要参与其担任裁决者的临床试验的设计、资助、赞助、组织、实施、分析或监管时，CEC被定义为独立的。此外，独立性要求与指导委员会、赞助商、资助者、制造商、协调中心、其他独立委员会、核心实验室、医学监查员、安全医师、参与临床站点、统计学家或数据管理员、监管机构或当局不存在利益冲突，这些利益冲突可能影响（或被认为会影响）成员在评估试验数据时的客观性。此类利益冲突包括经济利益、指导或咨询角色（有偿或无偿）、决策职位以及直系亲属关系。独立裁决者在临床试验中没有其他角色。
本共识声明提出了临床研究组织、制造商和研究者应考虑的独立CEC的标准化定义。此外，它还提供了关于实施独立CEC的最佳实践建议。
