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

在随机试验中，黑人、亚洲人和少数族裔（BAME）群体的代表性通常很差。正如我们在新闻中看到的那样，BAME社区受到COVID-19的影响尤为严重，这意味着针对COVID-19的治疗和疫苗试验必须包括具有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，在9项已发表的COVID-19试验中，只有1项甚至提到了种族。在ClinicalTrials.gov（美国临床试验登记处）上注册的1518项COVID-19研究中，目前只有6项正在收集种族数据。考虑种族因素在审判中并不常见。该项目将完成一个工具（称为INCLUDE种族框架），试验设计者可以使用它来确保他们考虑影响BAME参与的因素，如疾病、文化、被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，以判断试验结果对BAME社区的适用性。我们已经在没有资金的情况下完成了一些工作，其中包括来自BAME社区的患者和公众参与。该提案将使用该反馈来完成该工具。

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.