UK pilot finds practical value in Inclusion and Diversity Plans for trials
The MHRA and Health Research Authority have moved a step closer to making inclusion planning part of routine trial design in the UK. Findings from a 6-month pilot, run in 2025, show that researchers and sponsors saw value in preparing an Inclusion and Diversity Plan before a study opened for ethics review, even as the process itself still needs refinement.
Seven studies participated in the pilot, spanning both commercial and non-commercial sponsors. Five were phase 3 Clinical Trials of Investigational Medicinal Products, and two involved medical devices. Those study types matter because they sit near the point where evidence begins to influence real-world prescribing and procurement. If the participant population does not reflect the people who will later receive the drug or device, the external validity of the data weakens before the first patient is enrolled.
The plan is intended to force a more deliberate conversation at study design stage. Rather than treating recruitment diversity as an afterthought, it asks researchers to explain how they will enroll the full range of people who may use the intervention being tested. In practical terms, that means confronting barriers early: who is likely to be excluded by eligibility criteria, which communities may be harder to reach, and whether site selection or study materials will narrow participation before recruitment even begins.
A single sentence captures the policy shift neatly: diversity is being pulled upstream into protocol design.
Why the ethics review process is part of the story
The pilot also explored how Research Ethics Committees use the plan. REC members are not being asked to rubber-stamp inclusion language; they need information that helps them judge whether recruitment decisions are scientifically and ethically sound. The pilot findings indicate that the information RECs need to see, and the way it is presented, still requires further consideration.
That is not a minor formatting issue. Ethics review depends on clarity, because committee members have to understand not only who is being excluded, but why those exclusions are necessary and whether they are proportionate to the study question. When the structure of the plan is hard to navigate, the ethical review becomes harder to carry out consistently. The updated guidance now needs to do two jobs at once: guide investigators through the content and give reviewers a document that can be used efficiently in discussion.
Researchers and sponsors who took part said the plan was useful at the design stage. That is an important signal for a process that could easily have been treated as administrative friction. Instead, the pilot suggests the exercise can sharpen protocol thinking before recruitment starts, when changes are still possible and less costly than late-stage amendments.
The pilot exposed where the guidance still needs work
The findings point to a workable concept, but not yet a polished product. The guidance could benefit from further refinement so researchers can find the information they need more easily when completing the plan. In policy terms, that usually means the difference between a document that is conceptually persuasive and one that is operationally usable across a mixed research workforce.
The updated guidance has already been revised in response to the pilot. That matters because implementation often fails when the rules are sound but the instructions are cumbersome. A plan designed to broaden participation cannot depend on specialized interpretation from the people expected to use it at speed.
There is also a broader systems question here. Inclusion planning is being developed alongside reform of the UK clinical trial regulations and alongside cross-sector work through the UK Clinical Research Inclusion Group. The policy architecture is moving in the same direction: make research more representative, make participation easier to justify and document, and reduce the gap between the populations studied and the populations treated.
More participation should mean more usable evidence
The MHRA position is direct. Clinical research should reflect the diverse patient population served in the UK, and the evidence generated in medicines and med-tech development should be relevant beyond one narrow slice of the population. That has a scientific logic as well as a public health one. Trial populations that miss older adults, ethnic minority groups, people with comorbidity, or those facing structural barriers to access can produce evidence that is less reliable at the bedside, where clinicians are treating the full complexity of disease.
The HRA framed the pilot around the same principle: a more diverse participant group should improve understanding of which treatments, devices, and forms of care work best for different groups of people. When evidence is more representative, it is more likely to support treatment decisions that lower avoidable health inequalities rather than entrench them.
Wider rollout begins in 2027
From early 2027, more researchers and sponsors will be invited to volunteer to submit a plan with their applications, with feedback collected over a 12-month period. During that window, plans will be reviewed by a small number of participating RECs. Researchers and sponsors can express interest by emailing the HRA engagement team.
The process remains voluntary and is not a legal requirement under the new clinical trials regulations introduced in April. That voluntary status may help participation in the early phase, but it also means adoption will depend on whether the plan proves genuinely useful to sponsors, investigators, and ethics committees rather than simply adding another document to the submission package.
For now, the pilot findings support a clear direction: inclusion planning has enough merit to continue, but the wording, format, and REC-facing structure all need further refinement before the model is scaled more widely. The next implementation phase will test whether a better-designed plan can move from policy aspiration to routine research practice without losing clarity at the point where trial design becomes real.