Sponsors taking part in a UK pilot that tasked them with laying out how they plan to enrol the full range of people who will use their product found the early planning beneficial.
The six-month pilot, which was run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA), encouraged participants to 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The draft guidance on developing a plan was tested by a small group of commercial and non-commercial researchers and sponsors.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. As well as helping researchers in their planning, it also assists RECs to understand decisions researchers have made about who to recruit into their trials, to support discussions at the research ethics review meeting.
The pilot included seven clinical trials, including both commercial and non-commercial sponsors. Five of the studies were Phase III trials of investigational medicinal products, and two were for medical devices.
The feedback from commercial sponsors who took part was that they found developing a plan beneficial in supporting them to consider inclusion and diversity in a more structured way, while also improving conversations with sites around recruitment.
Non-commercial sponsors, however, found developing the plan less beneficial, in part due to these sponsors having already considered inclusion and diversity to meet funding application requirements.
Feedback found that some areas need consideration, however, if this is to be properly implemented. This includes the information that RECs need to see and how it is presented, as well as the format of the guidance, with sponsors calling for further refinements to make it easier to find important information for researchers and sponsors.
This pilot is part of a wider move by the MHRA and HRA’s work to update the UK’s clinical trial regulations. More sponsors and researchers will be asked to submit a plan in early 2027, with further feedback to be collected over a 12-month period.
While the MHRA is encouraging diversity and inclusion, it is not yet a legal requirement or part of the new clinical trials regulations that were introduced in April.
Lawrence Tallon, CEO of the MHRA, 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.”
Naho Yamazaki, deputy director of policy and partnerships at the HRA, added: “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.”
Yamazaki added that enrolling diverse populations ensures a “better understanding of the most effective treatment, device and care for different groups of people”, in turn reducing health inequalities.
Diversity in clinical trials remains a key theme on a global scale. In 2024, the World Health Organization (WHO) said that sponsors should look beyond just race and gender when considering diverse patient populations. This includes patients from ethnic minorities and stigmatised populations such as those from the LGBTQI+ community and age extremes. The guidance goes on to recognise the need to include pregnant and lactating women, patients from lower socioeconomic backgrounds and patients who face language barriers.
An analysis run by the Global Observatory on Health Research and Development of all clinical trials in the International Clinical Trials Registry Platform (ICTRP) revealed that just 4% of clinical trials over the past decade allowed the inclusion of pregnant women, for example.
