背景:科学完整性计划需要针对随机临床试验(RCT)的具体建议。
目的:通过国际多方利益相关者共识,为RCT完整性准备一套声明。
方法:共识是通过多国家多学科利益相关者团体的组成和参与而形成的;有关RCT完整性的55项系统评价的证据综合;匿名的两轮修改的Delphi调查,共识阈值基于多数意见的平均百分比;以及,最后的共识发展会议。
结果:代表来自5大洲的15个国家的30个利益相关者,伦理学家,方法学家,统计学家,消费者代表,行业代表,系统审稿人,资助机构小组成员,监管专家,作者,期刊编辑,解决诚信问题的同行评审员和顾问。德尔菲调查回复率为86.7%(26/30利益相关者)。共有111份声明(73份利益相关者提供,46系统审查产生,8由两者支持)在最初的长列表中,在协商一致回合中提供了8项额外声明。通过协商一致,最终集合并81份声明(49份利益相关者提供,41系统审查产生,9由两者支持)。整个RCT生命周期由一组陈述涵盖,包括一般方面(n=6),设计和批准(n=11),行为和监测(n=19),方案和结果报告(n=20),出版后关注(n=12),以及未来的研究和发展(n=13)。
结论:这一多方利益相关者共识声明的实施有望提高RCT的完整性。
BACKGROUND: Science integrity initiatives require specific recommendations for randomised clinical trials (RCT).
OBJECTIVE: To prepare a set of statements for RCT integrity through an international multi-stakeholder
consensus.
METHODS: The
consensus was developed via multi-country multidisciplinary stakeholder group composition and engagement; evidence synthesis of 55 systematic reviews concerning RCT integrity; anonymised two-round modified Delphi survey with
consensus threshold based on the average percent of majority opinions; and, a final
consensus development meeting.
RESULTS: There were 30 stakeholders representing 15 countries from 5 continents including trialists, ethicists, methodologists, statisticians, consumer representative, industry representative, systematic reviewers, funding body panel members, regulatory experts, authors, journal editors, peer-reviewers and advisors for resolving integrity concerns. Delphi survey response rate was 86.7% (26/30 stakeholders). There were 111 statements (73 stakeholder-provided, 46 systematic review-generated, 8 supported by both) in the initial long list, with 8 additional statements provided during the consensus rounds. Through consensus the final set consolidated 81 statements (49 stakeholder-provided, 41 systematic review-generated, 9 supported by both). The entire RCT life cycle was covered by the set of statements including general aspects (n=6), design and approval (n=11), conduct and monitoring (n=19), reporting of protocols and findings (n=20), post-publication concerns (n=12), and future research and development (n=13).
CONCLUSIONS: Implementation of this multi-stakeholder
consensus statement is expected to enhance RCT integrity.