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)社区的代表性往往很差。正如我们在新闻中看到的，巴米社区受到新冠肺炎的影响不成比例，这意味着新冠肺炎的治疗和疫苗试验包括有巴米背景的人至关重要。目前还不清楚情况是否如此。英国正在进行的一项针对全球新冠肺炎试验设计质量的研究发现，已公布的9项新冠肺炎试验中只有1项提到了种族问题。在ClinicalTrials.gov(美国临床试验注册中心)注册的1,518项新冠肺炎研究中，目前只有6项在收集种族数据。这个项目将完成一个工具(称为包含种族框架)，试验设计者可以使用它来确保他们考虑到影响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。它还将帮助解释和报道新冠肺炎试验的人判断试验结果对巴美社区的适用性。我们已经在没有资金的情况下做了一些工作，其中包括巴美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.