Puttick Natasha F, Vanderslott Samantha, Tanner Rachel
Keble College, University of Oxford, Oxford, UK.
Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK.
BMJ Public Health. 2023 Oct 18;1(1):e000042. doi: 10.1136/bmjph-2023-000042. eCollection 2023 Nov.
The representation of ethnic minority groups in European vaccine trials is an important and hitherto unaddressed gap in the literature. The objectives of this study were to determine the proportion of European vaccine trials that report data on the ethnic demographics of participants, to evaluate the distribution of ethnic minority groups among trial participants (where reported), and ascertain whether this is representative of the wider population of the country.
We evaluated the representation of ethnic/racial minority groups in clinical research, conducting a quantitative analysis of clinical trials registry data from completed vaccine trials in Europe that commenced between 1 January 2010 and 31 December 2020.
Data were collected from four major clinical trial databases: ClinicalTrials.gov, the European Union Clinical Trials Register (EUCTR), the International Standard Randomised Controlled Trial Number (ISRCTN) and the International Clinical Trials Registry Platform (ICTRP).
A majority of clinical trials failed to either record or report the race/ethnicity of their volunteers on the clinical trials registry databases. Reported participants in UK vaccine trials were not representative of the ethnic demographics of the wider population. Unavailability of population-level ethnicity data for many European countries was a significant barrier to determining the wider applicability of these findings.
Under-representation of ethnic minority groups in vaccine trials may have implications for the effectiveness of routine vaccinations, threatening the principles of justice and equity that are embedded in national medical research guidelines. Unavailability of population-level ethnicity data exacerbates the prevailing lack of understanding of the extent of this issue, despite literature indicating cause for concern.
欧洲疫苗试验中少数族裔群体的代表性问题是文献中一个重要且迄今未得到解决的空白。本研究的目的是确定报告参与者种族人口统计学数据的欧洲疫苗试验的比例，评估试验参与者中少数族裔群体的分布情况（如有所报告），并确定这是否代表该国更广泛的人群。
我们评估了临床研究中少数族裔群体的代表性，对2010年1月1日至2020年12月31日期间在欧洲开展的已完成疫苗试验的临床试验登记数据进行了定量分析。
数据从四个主要临床试验数据库收集：美国国立医学图书馆临床试验数据库（ClinicalTrials.gov）、欧盟临床试验登记库（EUCTR）、国际标准随机对照试验编号（ISRCTN）和国际临床试验注册平台（ICTRP）。
大多数临床试验未能在临床试验登记数据库中记录或报告志愿者的种族/族裔。英国疫苗试验中报告的参与者并不代表更广泛人群的种族人口统计学情况。许多欧洲国家缺乏人口层面的族裔数据是确定这些研究结果更广泛适用性的重大障碍。
疫苗试验中少数族裔群体代表性不足可能会对常规疫苗接种的有效性产生影响，威胁到国家医学研究指南中所蕴含的公正和平等原则。尽管有文献表明令人担忧，但缺乏人口层面的族裔数据加剧了目前对这一问题严重程度的普遍缺乏了解。
