Burrow Rebekah, Carr Melanie, Goddard Lucy, Hinton Lisa, Clarke Mike
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Queen's University Belfast, Belfast, Northern Ireland, UK.
Trials. 2025 Jun 21;26(1):219. doi: 10.1186/s13063-025-08893-9.
Clinical trials need to include patients who are representative of the population who may receive the tested interventions in the future. The importance of inclusivity is recognised by ethical and funding bodies and has public support. Appropriate inclusion is required to provide equitable evidence-based healthcare and to comply with ethical principles for research. However, there is little information about the inclusivity of most under-served groups in UK clinical trials.
This audit assesses the inclusion of under-served groups in trials run by the Oxford Primary Care Clinical Trials Unit (PC-CTU). We included trials with ethical approval between 2017 and 2023. We checked protocols, patient-facing information and selected data collection tools for information on the under-served groups in the INCLUDE guidance and protected characteristics in the UK Equality Act 2010, to identify explicit exclusions and data collection.
We included 19 trials. They were in a variety of clinical conditions, testing different types of interventions, both Clinical Trial of an Investigational Medicinal Product (CTIMP) and non-CTIMP. Most were non-commercially funded. We reviewed 21 protocols, 29 Patient Information Sheets/Leaflets and 40 data collection tools. Common exclusions were based on age (19), sex or gender (11), language (8), capacity to consent (14), pregnancy (11), multiple health conditions (10) and severity of illness (17). Trials most often collected data on age (19), sex or gender (15), ethnicity (16), education (11), address (13), mental health conditions (6), who gave consent (19), addiction (6), multiple health conditions (10), severity of illness (17), smoking status (12) and obesity (13).
Often, exclusions were due to the focusing of the trial for a specific group, such as older people, women, or people being treated for a specific severity of condition. However, many explicit exclusions may not have been essential, may have reduced the inclusivity of the trials and might limit the applicability of the trial's findings to people to whom the tested interventions might be relevant. These include the exclusion of people aged under 18, people without English language fluency and people without capacity to consent. All trials could have collected more informative data on under-served group status.
临床试验需要纳入能够代表未来可能接受受试干预措施人群的患者。包容性的重要性得到了伦理和资助机构的认可，并获得了公众支持。为了提供公平的循证医疗服务并遵守研究伦理原则，需要进行适当的纳入。然而，关于英国临床试验中大多数服务不足群体的包容性信息却很少。
本次审核评估了牛津初级保健临床试验单位（PC-CTU）开展的试验中对服务不足群体的纳入情况。我们纳入了2017年至2023年期间获得伦理批准的试验。我们检查了方案、面向患者的信息以及选定的数据收集工具，以获取关于《包容性指南》中服务不足群体的信息以及2010年《英国平等法》中的受保护特征，从而确定明确的排除标准和数据收集情况。
我们纳入了19项试验。这些试验涉及多种临床情况，测试不同类型的干预措施，包括研究性药品临床试验（CTIMP）和非CTIMP。大多数试验没有商业资助。我们审查了21份方案、29份患者信息表/手册和40份数据收集工具。常见的排除标准基于年龄（19项）、性别（11项）、语言（8项）、同意能力（14项）、怀孕（11项）、多种健康状况（10项）和疾病严重程度（17项）。试验最常收集的数据包括年龄（19项）、性别（15项）、种族（16项）、教育程度（11项）、地址（13项）、心理健康状况（6项）、同意者（19项）、成瘾情况（6项）、多种健康状况（10项）、疾病严重程度（17项）、吸烟状况（12项）和肥胖情况（13项）。
通常，排除是由于试验针对特定群体，如老年人、女性或因特定疾病严重程度接受治疗的人群。然而，许多明确的排除标准可能并非必要，可能降低了试验的包容性，并可能限制试验结果对受试干预措施可能相关人群的适用性。这些排除包括排除18岁以下人群、英语不流利人群和无同意能力人群。所有试验都本可以收集更多关于服务不足群体状况的有用数据。
