The case for adaptive EDI strategies in the UK
Clinical research in the UK is on a mission to ensure everyone, regardless of who they are, can participate. From ethnicity and socioeconomic background to gender identity and disability, the conversation around equality, diversity, and inclusion (EDI) in health research is blossoming. But, while the significance of EDI in clinical research cannot be overstated, the path to achieving it is complex.
The UK is home to a rich tapestry of cultures, experiences, and backgrounds that interweave to form a broad spectrum of human diversity. Combined with its strong health research infrastructure, in theory the nation offers an ideal landscape to showcase the medical and industry benefits of embedding EDI practises. Yet, achieving this goal has proved challenging.
To ensure everyone in the UK can reap the benefits of research, we need different solutions at different stages of the research process. Embracing such adaptive strategies was the subject of a recent webinar, sponsored by the National Institute for Health and Care Research (NIHR), where panellists Barbara Molony-Oates (public involvement manager at the Health Research Authority), Rosamund Round (Parexel’s patient engagement team lead), Sarah Fallon (chief operating officer at NIHR Clinical Research Network, Greater Manchester), and Trishna Bharadia (multi-award winning patient advocate and patient engagement consultant) came together to discuss championing EDI efforts in the UK.
What is EDI?
Broadly speaking, EDI encompasses not just the demographics of study participants, but also the inclusivity of study designs, ensuring treatments are effective across diverse populations, such as those found in the UK. But, while the impact of championing EDI in research is well-documented, as Bharadia highlighted, awareness has not always translated into best practices. “For far too long, research has been conducted in groups that aren’t necessarily representative of the patient population, despite knowing that study results need to be generalisable to the wider patient population,” she said. This failure to prioritise EDI can have wide-reaching implications – first and foremost, Molony-Oates noted, is patient safety.
Achieving proportional representation of diverse populations in clinical studies is an ongoing challenge. However, there are significant obstacles, such as historical distrust in medical institutions among certain groups, lack of awareness about available studies, and logistical barriers that can impede participation. As Round highlighted, even terminology can unintentionally alienate groups: “The language you use is so important,” she explained. “I work in a global organisation, and some of the terminology that we use in the UK is deemed offensive in the US and vice versa.”
In the UK, the term “underserved” refers to populations that have lower inclusion in research than expected based on population estimates, experience a higher healthcare burden disproportionate to the research focused on their group, or face important differences in how they respond to or engage with healthcare interventions. However, as Molony-Oates noted, the definition is context-specific – for example, full-time working individuals may be considered underserved in clinical trials that only operate during typical business hours when they are unavailable.
A key distinction highlighted during the discussion is that between equality and equity. Equality, Bharadia noted, means treating everyone the same, regardless of individual needs or circumstances. In contrast, equity involves acknowledging and addressing those differences to ensure fair treatment and opportunities.
“Equity recognises that each person has different circumstances and allocates the exact resources and the opportunities that are needed so that you can reach an equal outcome,” she said. “So, within clinical research, that equal outcome for me is the opportunity to contribute to clinical trial design and the opportunity to participate in and complete a clinical study.”
Overcoming barriers to inclusive research
Achieving inclusive and representative clinical research requires directly addressing the systemic barriers that prevent the participation of underrepresented communities. Some key groups that have historically been left out include ethnic/racial minorities, elderly populations, those with disabilities, and other marginalised groups. The obstacles they face are multifaceted, stemming from factors like systemic discrimination, lack of access and awareness, logistical challenges, and deep-rooted mistrust of medical institutions.
As Round highlighted, even something as fundamental as language can inadvertently exclude communities if overlooked: “There’s a member of our patient advisory council who lives in Queens in New York and she said in her neighbourhood alone there are 20 common languages [...] If we’re providing patient education materials in the US, for example, you’d provide English and you’d provide Latin American Spanish. Well, if that’s all we do, we are inadvertently excluding many patients from learning about the trial in the first place.”
Socioeconomic factors, geography, and cultural nuances also pose significant barriers to participant recruitment and retention across diverse populations. Low-income individuals may lack flexibility, transportation, or ability to take time off work to participate. Rural or geographically isolated communities have less access to research centres.
Cultural norms around healthcare can lead to mistrust or different perceptions around clinical trials. Overcoming these hurdles requires proactive strategies, like designing more flexible study protocols, utilising digital tools and community outreach, implementing participatory research methods driven by the communities themselves and diversifying research sites. For example, Fallon highlighted that using a national site ID service, and allowing all sites to express an interest in bringing the study to their patients, is more inclusive than coming to the UK with pre-selected sites.
“We [the NIHR] have a site identification service that’s UK-wide, and anybody can access that service,” she said. “You can submit an idea, and that goes to all sites that have that particular speciality, but it also works across different settings.”
Fallon continued: “Most of us aren’t sitting in the hospital unless we are really poorly, but so much of our research is done through hospitals. Thinking about where we do the research in terms of geography and who we’re talking to, but also thinking about the service users and how they’re interacting with the service across different specialities is really important because if we just do what we’re always doing, we’re not getting any more inclusive at all, are we?”
Meaningful engagement from the start is key, as Bharadia noted: “Involvement in the development of trial materials [...] If somebody doesn’t see themselves in there, if they don’t feel that they can engage with or they can’t relate to the materials, that can be off-putting.”
Simple considerations like providing study information in plain language, large print, and multiple translations can go a long way. As one example, Bharadia shared that she “worked on a study where people just weren’t bringing their reading glasses, so they were struggling with the patient information sheet.”
Examples of effective EDI implementation
Successful efforts to increase diversity and inclusion in clinical trials often involve targeted recruitment strategies, partnerships with community organisations, and the development of culturally sensitive materials. To illustrate how, Bharadia provided an unexpected example: “In the East Midlands, the Centre for Ethnic Health Research set up this thing called ‘Play Domino, Talk Prostate’. Prostate cancer affects more Black men and, basically, as a result of this event, there was a domino club set up where Black men came, played dominoes, and talked about prostate cancer. It was in an informal setting where people felt comfortable [...] Initiatives like that can be really valuable because if you’re getting people together in a comfortable environment, they’re going to be much more receptive to talking about issues which, potentially, there have been trust issues around.”
Fallon recalled a similar event, noting that such informal spaces can help to foster positive and long-lasting relationships within communities. “In Greater Manchester, we have quite a large event in one of our boroughs for people who have dementia, and their carers. It’s a dementia dance, and there are buses of people that turn up on a Thursday afternoon,” she said. “So, rather than just sit there and design research or think about how we might deliver research, we really encourage people to go. Not just go and dance, but go and talk to the community.”
Alongside building these relationships through events, innovations such as virtual trials, mobile health apps, and social media campaigns were also spotlighted for their potential in helping to drive EDI in research by increasing awareness and accessibility. On the industry side of the spectrum, Molony-Oates touched upon efforts to encourage companies to begin looking at EDI earlier in the process: “In the Health Research Authority, we’re working with the MHRA to create diversity guidance for people [...] to get them to start thinking about diversity and inclusion really early on in study planning,” she explained.
Echoing early statements about accessibility of information for the layperson, Round noted the value of providing materials in a variety of formats. “We use an animation that explains what a clinical trial is [...] it can be recorded in local languages or have translations,” she said. “For people with literacy barriers, having visual and audio elements is important. Providing information in as many formats as possible is really important.”
Round further noted the value of shareable resources: “People can take [the video] away because in some communities it’s a family decision [...] You can share it, so everyone has heard the same information to make an informed choice.”
Ultimately, as the panel discussed, effective EDI requires a multifaceted approach – leveraging technology and multimedia, partnering with trusted community groups, designing materials through an inclusive lens from the start, and maintaining open lines of communication to continuously learn and adapt research practices.
“No one should be doing this on their own. It should be a collaborative approach, because what we don’t want is communities feeling as though that they’re being contacted, you know, in silos and just for single projects,” said Fallon. “We have to build up trust and relationships with communities if they’re going to want to take part in research and feel like a partner in the research that we do.”
Embrace the challenge
Achieving equitable representation in clinical research is not just a matter of numbers, but a dedication to inclusivity at every stage. By acknowledging the multifaceted nature of EDI and addressing the diverse needs of participants, we can ensure research truly benefits everyone. This collective effort requires a continuous commitment to learning, collaboration with communities, and accepting the fact that, as with evolution, mistakes will be made. But, as all the panellists agree, the fear of error should not discourage action.
“We have to urge people to not be afraid; to put your hand up and say, ‘I don’t know everything’,” said Molony-Oates. “It’s okay to make a mistake. But what is not okay is not to try, and I think we should never stop trying for fear of doing the wrong thing, because that’s going to cripple us.”
Ultimately, achieving impactful and equitable research will require a mindset shift from a blanket “one-size-fits-all” mentality to a personalised, inclusive, and culturally competent research landscape. As we strive towards this goal, the health and well-being of all will benefit from the advancements in healthcare, fuelled by a truly representative and diverse research pool.
