UK Trial Inclusion and Diversity Plans to Have ‘Wider Scope’ Than Those in US

By Vibha Sharma

The UK’s proposed approach to requiring inclusion and diversity plans from drug and medical device study sponsors is due to be unveiled next year and will go beyond the requirements currently in place in the US for this topic.

The US Food and Drug Administration’s requirement for diversity action plans is focused on improving the enrollment of participants from underrepresented racial and ethnic populations in the US, explained the Health Research Authority (HRA), which is responsible for overseeing research ethics committees across the UK.

In contrast, the UK’s inclusion and diversity plan will have a “wider scope” and ask “researchers to consider [aspects] beyond participant’s race and ethnicity,” HRA staff told the Pink Sheet. The aim of the UK’s approach is to ensure that clinical research is designed to include people who could benefit from the findings, and that people underserved by research are not overlooked.

As part of this effort, the HRA is working with the Medicines and Healthcare products Regulatory Agency (MHRA) to develop a set of questions and supporting guidance for researchers to consider when they design clinical trials and clinical investigations.

The questions will be used to design the inclusion and diversity plan. “Researchers and sponsors will fill in the Plan for Research Ethics Committees and the MHRA, who will use the information in the plan to inform the review for clinical trials,” HRA staff explained.

The current intention is for sponsors to complete the plan for all UK trials. “The plan will ask researchers to provide specific information which will be used for review by research ethics committees and the MHRA,” they added.

To support a smooth uptake of this new requirement, the MHRA and HRA will undertake an “informal consultation” on the draft plan and supporting draft guidance next year. “Following this, the current plan is to have a period of ‘consultation in use’ so that we can collect feedback from researchers and consider any revisions to the plan and guidance,” staff said.

The MHRA and HRA have been engaging widely with the research community as part of this work to develop the supporting guidance, which will focus on how to complete the inclusion and diversity plan. This has included hosting three workshops between July and September with a small group of researchers, funders, members of the public, industry, and research ethics committee members to develop an initial draft of the guidance.

Strong Public Support

The need to improve diversity among clinical trial participants has been an ongoing concern for some time now, but the issue gained prominence during the COVID-19 pandemic when discussions around inequitable access to research and treatments became more pronounced.

In the US, the need for diversity action plans for most drug and device trials became mandatory under the Food and Drug Omnibus Reform Act of 2022 (FDORA). While the UK also initially proposed to legislate new requirements to improve trial diversity and patient involvement in research, it later opted to develop clear practical guidance on these topics. (Also see "UK’s Revamped Clinical Trials Framework to Offer Faster Application Review Timelines Than EU" - Pink Sheet, March 22, 2023.)

A recent YouGov survey, commissioned by the HRA, also showed strong public support for improving diversity in research. The survey collected data from a representative sample of 5,030 people from across the UK. The survey findings published on Nov. 22 showed:

• Nine in 10 (88%) people think a diverse mix of participants in health and social care research is important. 
• The majority of the public believes it is important to include a diverse mix of participants even if the research costs more money (70%) or takes more time (74%).
• Diversity affects confidence in research funded by the private sector, such as pharmaceutical companies, with over half (52%) saying they have more confidence in the findings if the study includes a diverse mix of participants.
• Black adults are less confident that they would be looked after while taking part in research (30%) than Asian adults (20%) and white adults (18%).

HRA chief executive Matt Westmore said: “We commissioned this survey to better understand the public’s attitudes towards health and social care research and to identify what matters to them so that we can make it easier to do research that people can trust.”

Improving diversity was also high on the agenda of the review undertaken by former health minister Lord James O’Shaughnessy to improve the state of commercial clinical trials in the UK. (Also see "UK Aims to Quadruple Patient Recruitment to Industry Clinical Trials by 2027" - Pink Sheet, June 1, 2023.)

In response to the HRA survey, Lord O’Shaughnessy said: “The diverse nature of our population should be a superpower for UK clinical research, enabling us to provide data that is relevant to almost every country in the world while bringing innovative new treatments to the British communities.”

In addition to its ongoing work with the MHRA, the HRA staff said it would use the survey findings to:

• Clarify expectations of researchers by updating the UK policy framework for health and social care research on diversity.
• Share the principles and hallmarks for good people-centered clinical research with the research community to help them to put people first.