英国国家卫生与临床优化研究所（NIHR）关于新冠大流行及之后远程临床试验交付的英国工作组报告。
A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond.
机构信息
Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
College of Medicine and Health, University of Exeter, Exeter, UK.
出版信息
Trials. 2021 Dec 11;22(1):911. doi: 10.1186/s13063-021-05880-8.
BACKGROUND
Prior to the COVID-19 pandemic, the majority of clinical trial activity took place face to face within clinical or research units. The COVID-19 pandemic resulted in a significant shift towards trial delivery without in-person face-to-face contact or "Remote Trial Delivery". The National Institute of Health Research (NIHR) assembled a Remote Trial Delivery Working Group to consider challenges and enablers to this major change in clinical trial delivery and to provide a toolkit for researchers to support the transition to remote delivery.
METHODS
The NIHR Remote Trial Delivery Working Group evaluated five key domains of the trial delivery pathway: participant factors, recruitment, intervention delivery, outcome measurement and quality assurance. Independent surveys were disseminated to research professionals, and patients and carers, to ascertain benefits, challenges, pitfalls, enablers and examples of good practice in Remote Trial Delivery. A toolkit was constructed to support researchers, funders and governance structures in moving towards Remote Trial Delivery. The toolkit comprises a website encompassing the key principles of Remote Trial Delivery, and a repository of best practice examples and questions to guide research teams.
RESULTS
The patient and carer survey received 47 respondents, 34 of whom were patients and 13 of whom were carers. The professional survey had 115 examples of remote trial delivery practice entered from across England. Key potential benefits included broader reach and inclusivity, the ability for standardisation and centralisation, and increased efficiency and patient/carer convenience. Challenges included the potential exclusion of participants lacking connectivity or digital skills, the lack of digitally skilled workforce and appropriate infrastructure, and validation requirements. Five key principles of Remote Trial Delivery were proposed: national research standards, inclusivity, validity, cost-effectiveness and evaluation of new methodologies.
CONCLUSIONS
The rapid changes towards Remote Trial Delivery catalysed by the COVID-19 pandemic could lead to sustained change in clinical trial delivery. The NIHR Remote Trial Delivery Working Group provide a toolkit for researchers recommending five key principles of Remote Trial Delivery and providing examples of enablers.
背景
在 COVID-19 大流行之前，大多数临床试验活动都是在临床或研究单位面对面进行的。COVID-19 大流行导致临床试验的交付方式发生了重大转变，不再需要面对面的接触，即“远程临床试验交付”。英国国家卫生研究院（NIHR）成立了一个远程临床试验交付工作组，以研究临床试验交付方式发生这一重大转变所面临的挑战和推动因素，并为研究人员提供一个工具包，以支持向远程交付的过渡。
方法
NIHR 远程临床试验交付工作组评估了临床试验交付途径的五个关键领域：参与者因素、招募、干预措施交付、结果测量和质量保证。向研究专业人员以及患者和护理人员分发了独立的调查，以确定远程临床试验交付中的获益、挑战、陷阱、推动因素和良好实践的例子。构建了一个工具包，以支持研究人员、资助者和治理结构向远程临床试验交付转变。该工具包包括一个网站，涵盖了远程临床试验交付的关键原则，以及一个最佳实践例子和问题的存储库，以指导研究团队。
结果
患者和护理人员的调查收到了 47 名受访者的回复，其中 34 名是患者，13 名是护理人员。专业人员的调查收到了来自英格兰各地的 115 个远程临床试验实践的例子。主要潜在获益包括更广泛的覆盖范围和包容性、标准化和集中化的能力、提高效率和患者/护理人员的便利性。挑战包括可能排除缺乏联网或数字技能的参与者、缺乏数字技能劳动力和适当的基础设施、以及验证要求。提出了远程临床试验交付的五项关键原则：国家研究标准、包容性、有效性、成本效益和新方法的评估。
结论
COVID-19 大流行催生出的向远程临床试验交付的快速转变可能会导致临床试验交付方式的持续改变。NIHR 远程临床试验交付工作组为研究人员提供了一个工具包，建议了远程临床试验交付的五项关键原则，并提供了推动因素的例子。
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