Blog: inclusivity in clinical trials

The Health Research Authority’s mission is to make it easy to do research that people can trust, so that high-quality health and social care research improves everyone’s health and wellbeing.

One of our guiding principles is to ‘include’ because when research is done with and for everyone, we can all benefit from research findings.

Including diverse groups of people in clinical trials gives us more robust data, demonstrating more clearly if a medical product or intervention benefits everyone or if they work differently for different groups of people. Understanding this is a key aspect of addressing, or at least stopping to exacerbate, health inequalities.

Better clinical data through greater diversity of trial participants also benefits life science companies, because it supports reimbursement and uptake of their products.

The UK is a highly diverse nation and, coupled with a strong research infrastructure, it provides a unique environment for global investment in diverse trials, boosting the UK’s economy and supporting growth.

Our aim is to improve representation in health and social care research by supporting researchers and sponsors to plan for inclusion of the right people in the right ways, so that research enables people it is for and about to take part, including those who are traditionally underserved by research.

And there is strong public support for this. An online survey of just over 5,000 adults across the UK showed that 88% think it’s important to include a diverse mix of participants in research. This is even if the research costs more money (70%) or takes more time (74%).

So how can we improve representation in research?

Improving research design so that the right people are considered

Including the right people in research needs to be thought about at the start of the research process but this is not always happening. And issues are often picked up too late, for example by Research Ethics Committees (RECs), at which point there is often insufficient funding available to change the research design or the research gets delayed.

To help address this, we have developed and will be piloting guidance on how to develop an inclusion and diversity plan, with the Medicines and Healthcare products Regulatory Agency (MHRA). This will help researchers to plan how their clinical trials can be more representative of the people it is for and about.

We also hope this will help RECs to understand the justification for decisions researchers have made, and to support them in making their ethical judgements. And we are liaising with the National Institute of Health and Care Research, who recently introduced inclusive research design as a funding condition, so that our expectations are aligned.

The guidance asks at the start who is affected by the disease or condition that the medical product or intervention is trying to address. Researchers are then asked to show how the people who they intend to recruit, and the overall design of their trial or their wider plan to develop the product or intervention, will generate findings that will be applicable to the people who will eventually use those products or intervention.

Making sure that the right people can take part in the right way

Designing research to include the people it is for and about is the first step. We also need to make sure that those people can and want to take part in research.

The online survey mentioned above showed that 68% of UK adults would take part in research, if asked. Our work on supporting people-centred clinical research also suggests that given the right opportunities, many people would choose to take part, and that there are three things important to them in doing so:

• trust – people trust the research and the research team
• purpose – people feel the purpose is worthwhile
• possibility – people find it possible to take part in it

To support these three things that matter most to people when taking part, we want to make sure that research is easier to find, understand, take part in, and trust.

Making studies easier to find

Pushing for 100% registration of clinical trials is one way to make sure that people can more easily find out what research is taking place in the UK.

Trial registration is a condition of REC approval, and for clinical trials of medicines it will become a legal requirement. We now publish a full list of trials that received a favourable opinion from RECs with the registration details that we hold for them, starting with those approved in 2022.

Making research information easier to understand

Participant facing material designed and developed with people with relevant experience of the condition that is being studied, or members of appropriate community groups, help make trials easier to understand. Our participant information quality standards, and design and review principles, aims to embed this as routine practice.

Making it easier to take part

Involving people and communities with relevant knowledge and experience is also crucial in designing trials, so that they are acceptable for the intended participants, and easier to take part. Decentralised trial (DCT) methods are another way to make participation easier and possible for wider groups of people. We have set out our intent in our DCT position statement, sharing encouragement and resources.

Building trust in research

Co-production through respectful and meaningful involvement of people and communities supports people’s trust in research, helping to take away potential participant’s concerns that they may be harmed or exploited, and to agree with the purpose. Transparency is also crucial for gaining people’s trust. Of the three pillars of transparency that we have been focussing on, we know that more needs to be done to improve researchers feeding back the findings of their studies to, and thanking, participants.

But there is still much more to do, and we really need to take a cross-sector, collaborative approach on, for instance:

• alignment of expectations of funders and regulators, in the UK and globally
• long-term, sustained and ethical engagement of communities in a way that do not overwhelm them
• training and fostering a diverse community of researchers
• healthcare professionals encouraged and supported to present research opportunities to patients as a part of routine care
• sharing knowledge within and across sectors
• getting data on who is being recruited into trials so that at the system level we know whether the interventions we are putting into place are making a difference

One thing for sure is that there is a real desire and momentum for change. I am optimistic that we can keep pushing, with our partners, so that more research enables people it is for and about to take part.