Ensuring that COVID-19 trials consider ethnicity: the INCLUDE Ethnicity Framework for randomised trials

确保 COVID-19 试验考虑种族：随机试验的 INCLUDE 种族框架

• 批准号: MR/V020544/1
• 负责人: Shaun Treweek
• 金额: $ 1.93万
• 依托单位: University of Aberdeen
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FV020544%2F1
• 关键词: Ensuring; COVID; 19; trials; consider

Representation of the Black, Asian and minority ethnic (BAME) community in randomised trials is often poor. As we have seen in the news, the BAME community is disproportionately affected by COVID-19, which means it is essential that trials of treatments and vaccines for COVID-19 include people with BAME backgrounds. It is not clear that this is currently the case. Ongoing UK work looking at the design quality of global COVID-19 trials has found that just 1 of 9 published COVID-19 trials even mentions ethnicity. Of 1518 COVID-19 studies registered on ClinicalTrials.gov (the US registry of clinical trials), only six are currently collecting data on ethnicity. Considering ethnicity is not routine in trials.This project will complete a tool (called the INCLUDE Ethnicity Framework) that trial designers can use to make sure they think about factors that affect BAME involvement such as disease, culture, treatment being tested and trial information and procedures. It will also help people interpreting and reporting COVID-19 trials to make judgements about the applicability of trial results to BAME communities.We have already done some work without funding and this has included patient and public involvement from the BAME community. This proposal will use that feedback to finish the tool.

在随机试验中，黑人、亚裔和少数民族（BAME）社区的代表性往往很差。正如我们在新闻中看到的，BAME社区受到COVID-19的影响不成比例，这意味着COVID-19的治疗和疫苗试验必须包括BAME背景的人。目前尚不清楚情况是否如此。英国正在进行的研究全球COVID-19试验的设计质量的工作发现，9个已发表的COVID-19试验中只有1个甚至提到了种族。在ClinicalTrials.gov（美国临床试验注册处）注册的1518项COVID-19研究中，目前只有6项正在收集种族数据。考虑种族在试验中并不是常规的。该项目将完成一个工具（称为INCLUDE Ethnicity Framework），试验设计者可以使用该工具来确保他们考虑影响BAME参与的因素，如疾病，文化，正在测试的治疗以及试验信息和程序。它还将帮助人们解释和报告COVID-19试验，以判断试验结果是否适用于BAME社区。我们已经在没有资金的情况下完成了一些工作，其中包括BAME社区的患者和公众参与。本建议书将使用该反馈来完成工具。

项目成果

Additional file 7 of Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve

开发 INCLUDE 种族框架的附加文件 7——帮助试验者设计更好地反映他们所服务的社区的试验的工具

• DOI: 10.6084/m9.figshare.14570510
• 发表时间: 2021
• 作者: Treweek S

Additional file 8 of Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve

开发 INCLUDE 种族框架的附加文件 8——帮助试验者设计更好地反映他们所服务的社区的试验的工具

• DOI: 10.6084/m9.figshare.14570513
• 发表时间: 2021
• 作者: Treweek S

Additional file 3 of Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve

开发 INCLUDE 种族框架的附加文件 3——帮助试验者设计更好地反映他们所服务的社区的试验的工具

• DOI: 10.6084/m9.figshare.14570498
• 发表时间: 2021
• 作者: Treweek S

Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve.

• DOI: 10.1186/s13063-021-05276-8
• 发表时间: 2021-05-10
• 期刊: Trials
• 影响因子: 2.5
• 作者: Treweek S;Banister K;Bower P;Cotton S;Devane D;Gardner HR;Isaacs T;Nestor G;Oshisanya A;Parker A;Rochester L;Soulsby I;Williams H;Witham MD
• 通讯作者: Witham MD

Additional file 6 of Developing the INCLUDE Ethnicity Framework-a tool to help trialists design trials that better reflect the communities they serve

开发 INCLUDE 种族框架的附加文件 6——帮助试验者设计更好地反映他们所服务的社区的试验的工具

• DOI: 10.6084/m9.figshare.14570507
• 发表时间: 2021
• 作者: Treweek S