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pilot, which ran for 6 months in 2025, the Medicines and Healthcare products Regulatory Agency’s (MHRA) and the HRA’s draft guidance on developing a plan was tested by a small group of commercial and non-commercial researchers and sponsors.
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The group submitted a Plan alongside their application for a Research Ethics Committee (REC) review.
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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.
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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.
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The development of the guidance was part of the MHRA and HRA’s work to update the UK’s clinical trial regulations.
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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.
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The pilot findings
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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.
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Overall, the findings from the pilot indicate that:
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\n - researchers and sponsors who took part found benefit in developing a Plan at the point of study design
\n - the information that RECs need to see in the Plan and how it is presented to them needs further consideration
\n - 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
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Next steps
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From early 2027 we will be asking more researchers and sponsors to volunteer to submit a Plan alongside their applications.
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Feedback will be collected over a 12 month period where we will gather further evidence on the benefits of developing a Plan.
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During this period, researchers and sponsors will be able to submit a Plan for review to one of a small number of participating RECs.
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You can express your interest in taking part by emailing engagement.team@hra.nhs.uk.
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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.
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Lawrence Tallon, Chief Executive of the Medicines and Healthcare products Regulatory Agency said:
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\n 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.
\n\n 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.
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Naho Yamazaki, Deputy Director of Policy and Partnerships at the HRA, said:
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\n 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.
\n\n 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.
\n\n 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.
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