药物临床试验：包容性与多样性计划试点结果发布
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新闻稿 药物临床试验：包容性和多样性计划试点结果发布 英国卫生研究管理局（HRA）已发布其关于临床试验和临床研究的研究者与申办方制定并提交包容性和多样性计划的试点结果。 来源： 英国药品和保健产品监管局 发布时间： 2026年11月3日 在该试点期间（于2025年开展，历时6个月），英国药品和保健产品监管局（MHRA）和HRA关于制定该计划的指南草案由一小群商业和非商业研究者和申办方进行了测试。 该小组在提交研究伦理委员会（REC）审查申请的同时提交了一份计划。 该计划帮助研究者考虑并展示他们计划如何招募将使用其所测试药物、器械或干预措施的全部人群范围。 该计划还帮助REC了解研究者关于招募哪些人进入其试验所作出的决定，以支持研究伦理审查会议上的讨论。 该指南的制定是MHRA和HRA更新英国临床试验法规工作的一部分。 该指南及其实施也为英国临床研究包容性小组更广泛的跨部门工作提供支持，以促进临床研究的更大可及性和包容性。 试点结果 共有七项研究参与了试点，包括来自商业和非商业申办方的研究。其中五项是研究性药品的3期临床试验，两项是医疗器械试验。 总体而言，试点结果表明： 参与的研究人员和申办方认为在研究设计阶段制定计划具有益处 伦理审查委员会（RECs）需要在计划中看到的信息以及向其呈现信息的方式需要进一步考虑 指南的格式可以通过进一步完善而受益，以便更容易找到研究人员和申办方完成计划所需的重要信息 查看包容性与多样性试点结果。 最新版指南现已根据试点结果进行了更新。 后续步骤 从2027年初开始，我们将邀请更多研究人员和申办方自愿在提交申请的同时提交计划。 将在12个月的时间内收集反馈，在此期间我们将收集关于制定计划益处的进一步证据。 在此期间，研究人员和申办方将能够向少数参与伦理审查委员会之一提交计划进行审查。 您可以通过发送电子邮件至engagement.team@hra.nhs.uk表达参与意向。 虽然鼓励研究人员和申办方提交计划，但这并非法律要求，也不是四月份引入的新临床试验法规的一部分。 英国药品和健康产品管理局（MHRA）首席执行官Lawrence Tallon表示： 我们希望临床研究能够反映我们在这个国家所服务的多样化患者群体。这也意味着在这里进行的药物和医疗器械开发中所产生的证据将具有相关性并在世界范围内受到重视。 我们欢迎这项有价值的工作，并将与HRA及其他合作伙伴合作，利用其洞见来提高临床研究中参与者的多样性。 HRA政策与伙伴关系副主任Naho Yamazaki表示： 我们试点项目的发现表明，在研究设计阶段制定包容性与多样性计划具有明显益处。该试点项目也非常有助于了解伦理审查委员会（RECs）需要在计划中看到哪些内容，以便为其伦理审查讨论提供信息。 我们正在利用反馈和洞见为下一个12个月的实施阶段做准备，以确保计划制定者和审查者都能充分受益。 这一点非常重要，因为在研究中纳入多样化的人群群体有助于更好地理解对不同人群群体最有效的治疗、器械和照护。这可以帮助人们获得最适合他们的照护，从而减少健康不平等。 分享此页面 以下链接将在新标签页中打开 在Facebook上分享 （在新标签页中打开） 在X上分享 （在新标签页中打开） 相关内容 合集 药品：临床试验中心 探索该主题 临床试验与调查研究
正文 · 英文原文
News story Clinical trials for medicines: Inclusion and Diversity Plan pilot findings published The Health Research Authority (HRA) has published the findings from its pilot on researchers and sponsors of clinical trials and clinical investigations developing and submitting an Inclusion and Diversity Plan. From: Medicines and Healthcare products Regulatory Agency Published: 3 November 2026 During the pilot, which ran for 6 months in 2025, the Medicines and Healthcare products Regulatory Agency’s (MHRA) and the HRA’s draft guidance on developing a plan was tested by a small group of commercial and non-commercial researchers and sponsors. The group submitted a Plan alongside their application for a Research Ethics Committee (REC) review. The Plan helps researchers consider and demonstrate how they plan to enrol the full range of people who will use the drugs, devices or intervention they are testing. The Plan also helps RECs to understand decisions researchers have made about who to recruit into their trials, to support discussions at the research ethics review meeting. The development of the guidance was part of the MHRA and HRA’s work to update the UK’s clinical trial regulations. The guidance and its implementation also feeds into the wider cross-sector work of the UK Clinical Research Inclusion Group, to support greater access to, and inclusion in, clinical research. The pilot findings Seven studies took part in the pilot, including studies from commercial and non-commercial sponsors. Five of the studies were phase 3 Clinical Trials of Investigational Medicinal Products and two were for medical devices. Overall, the findings from the pilot indicate that: researchers and sponsors who took part found benefit in developing a Plan at the point of study design the information that RECs need to see in the Plan and how it is presented to them needs further consideration the format of the guidance could benefit from further refinements to make it easier to find important information that researchers and sponsors need to complete the Plan View the inclusion and diversity pilot findings. The latest version of the guidance has now been updated in response to the pilot findings. Next steps From early 2027 we will be asking more researchers and sponsors to volunteer to submit a Plan alongside their applications. Feedback will be collected over a 12 month period where we will gather further evidence on the benefits of developing a Plan. During this period, researchers and sponsors will be able to submit a Plan for review to one of a small number of participating RECs. You can express your interest in taking part by emailing engagement.team@hra.nhs.uk. While researchers and sponsors are encouraged to submit a Plan, it’s not a legal requirement or part of the new clinical trials regulations that were introduced in April. Lawrence Tallon, Chief Executive of the Medicines and Healthcare products Regulatory Agency said: We want clinical research to reflect the diverse patient population we serve in this country. That also means the evidence generated in the development of medicines and med tech here will be relevant and valued around the world. We welcome this valuable work and, in collaboration with the HRA and other partners, will use its insights to improve the diversity of participants in clinical research. Naho Yamazaki, Deputy Director of Policy and Partnerships at the HRA, said: The findings from our pilot show that there is clear benefit in developing an Inclusion and Diversity Plan at the point of study design. The pilot was also really helpful in understanding what RECs need to see in the Plan to inform their ethics review discussions. We are using the feedback and insights to prepare for the next 12-month implementation phase to ensure full benefits for people both developing and reviewing the Plan. This is very important as including a diverse group of people in research provides a better understanding of the most effective treatment, device and care for different groups of people. This can help people get the best care for them and so reduce health inequalities. Share this page The following links open in a new tab Share on Facebook (opens in new tab) Share on X (opens in new tab) Related content Collection Medicines: clinical trials hub Explore the topic Clinical trials and investigations