In DDW and ELRIG UK’s Drug Discovery 2021 supplement, CEO and Founder of Egality Health, Annette Crosse, offers insight into the importance of diversity in clinical trials and of overcoming limitations in healthcare research to re-imagine a system which provides safe, effective and innovative therapies for the entire population.
Annette Crosse describes Egality Health as a start-up connecting community organisations with health research and clinical trials. Its vision is for health research to represent everyone and its mission is that health research and clinical trials in the UK fully represents the population.
According to Crosse: “We run programmes with community organisations and the sector to conduct outreach on, and inform, health research. Our community leaders bring expertise, experience and knowledge on how to do this authentically and respectfully. The community organisations we work with are the core of the company, and their values guide our work and approach.”
The importance of diversity
There are considerable and persistent health inequalities experienced by the ethnic minority population in the UK. Crosse explains that there is a paradox where the people most impacted by health inequalities are least represented in clinical trials. She says: “If people are not represented in clinical trials, the treatments developed may not be as safe or as effective for them. Working on homogenous evidence also means we could be missing out on innovative discoveries. Why do certain conditions impact people differently? Why are different treatments more effective? There are so many unexplored areas to research and discover.”
Crosse says diversifying health research and clinical trials in drug discovery is paramount. She says: “If we are only working with a segment of the population, we only have a small part of the picture. Working with a diverse range of people will mean rich data sets and new insights on how conditions effect different people, and how effective treatments are.”
This is particularly relevant in genomics medicine; the larger and more diverse the sample, the more can be found out about the condition being investigated, and better treatments are developed.
Crosse has compiled a list of the top three main issues with the current clinical trials process and how could they be overcome:
- The recording of ethnicity data must be improved. Without this we will not be able to understand the scale of under-representation, and benchmark improvement. National standards and guidance are a must for this country.
- At a leadership level, recruiting diverse groups should be considered at the very start of the trial design process, and reflected in the budget, it will take time and investment.
- On a local level, Clinical Teaching Units (CTUs) need to build better relationships with local communities, this should be supported by a national effort to improve public awareness about the benefits of being involved in research and trials.
Crosse says: “This is rethinking the process, and including people currently under-represented in making improvements to the design of research and trials. Digital advances and centralised trials will certainly support this, but only if accompanied strong local relationships and better national awareness.”
Crosse explains that diversity in clinical trials would result in drugs being more applicable to populations where there is an unmet need and discoveries would be more innovative, representing more of the population. Consequently, a greater proportion of the population would be actively involved in research and trials which would ultimately mean better results and a better reputation for the industry.
To address the lack of adequate diversity in clinical trials, the National Institutes of Health (NIH) in the US adopted a policy in 1993 mandating all federal grants for clinical research to include women and minorities. There is no legislation on this in the UK. Crosse comments: “We actually hosted a panel discussion on this back in November. The overriding response was that without proper support for those delivering the research, legislation would just become more bureaucratic red tape that people tried to get around. We do need clearer standards and guidance from the regulators on what they expect from diversity in trials, and for this to follow through in funding for those delivering research and trials.”
When compared with other global clinical trials processes, the UK is “not the best, and it is not the worst,” according to Crosse. “No country is a trailblazer on this yet. Though the US is more advanced, progress is still slow. There is an opportunity for the UK to set themselves apart by pioneering new approaches to improving diversity and representation across the country,” she adds.
Recruiting study participants is famously difficult across populations, with economic and social factors just some of the issues preventing people from participating. There are different methods developing across the country, but no nationally recognised system. Crosse says: “People still view clinical trials as creepy white coat / lab situations. Is there a way to emphasise that they can be an easy at home experiences that enable you to know more about your own health, as well as improve that of your communities? That’s the vision we should be striving towards.”
“For an industry that literally saves lives, the pharmaceutical industry is still deeply mistrusted by people and communities. The only way to shift this is to start having honest conversations about why this legacy exists, and what companies can do to build trust nationally and locally, through work with CTUs etc.”
About the author
Annette Crosse is CEO / Founder of Egality, a start-up connecting culturally diverse communities with health research and clinical trials. Crosse previously worked as a policy consultant to pharmaceutical companies, and as Chair of the Board for the Social Action for Health charity. She combined this experience to found Egality.
Volume 22, Issue 4 – Fall 2021 / ELRIG Drug Discovery 2021 supplement