Clinical Trial Diversity: How to Achieve it
The COVID-19 pandemic has brought many of society’s shortcomings to the fore, especially as it relates to diversity in clinical trials. So what are we going to do about it?
Let me give you an example…
Racial and ethnic minorities make up 39% of the population in the U.S., but represent just 1% of clinical trial participants. This is concerning considering that research has shown that minorities are overwhelmingly more affected by the SARS-CoV-2 virus than the rest of the population. Looking at COVID globally, it also appears that the more diverse a country’s population the higher the death toll. Does this mean that there is some genetic basis for this susceptibility? Research has not born this out. The virus appears to be indiscriminate. So what’s the actual problem?
Well, the most obvious answers are usually the most valid. In countries with high ethnic minorities, most live in low income, or poverty stricken areas. And populations in those areas are less likely to have access to sufficient healthcare. Access to healthcare is a deep seated problem that needs to be addressed by governments on an individual basis. In the case of COVID, effective therapeutics and vaccines are one piece of the puzzle. But there still remains the question of how to ensure these populations are able to get these products. While there are many thought pieces, initiatives and efforts under way to address this challenge (See Agency for Healthcare Research and Quality , Healthy People 2030 , Jay Bhatt et al , Rural Health Information Hub ), that’s a topic for another blog. Getting the safest and most efficacious therapeutics and vaccines for the diverse population of the globe is the topic of this one.
Let’s go to back to our example. In the US, COVID deaths are more prevalent in minority populations than the rest of the country. Income disparity is one part of the problem, but there are also challenges with electronic health records (language barriers, minority participation), the cost of participating in trials because many of them are not fully covered by insurance, and the lackluster outreach to diverse populations. And then perhaps the elephant in the room is the lack of trust. These challenges can be extrapolated to countries around the globe, so perhaps the solutions can also be applied globally.
There still remains the fundamental issue that in order for the safety and efficacy of a therapeutic or vaccine to be optimized it must be tested in the clinic in as diverse a population as possible. And in order for this to happen, there must be a willing diverse population. But that’s not the case. So why is it hard to get these volunteers?
Whether from overzealous researchers or ignorance on the part of the subject, the literature is replete with clinical trials gone awry in minority populations. The most egregious example of breach of trust is the Tuskegee Syphilis study in the 1930’s. That travesty still lives in the minds of minority populations today and who can blame them. It is a fact that minorities in the US are less likely to participate in clinical trials for fear of being exploited. So what has society done to earn that trust back?
There are laudable examples of piecemeal efforts like the World Medical Association’s Helsinki Declaration for Ethical Medical Research first adopted in 1964 (and modified several times since), the World Health Organization’s (WHO) Handbook for Good Clinical Research Practice in 2002, the International Council on Harmonization’s (ICH) Good Clinical Practice guidelines which are currently under revision, and even the pharmaceutical industry’s own set of principles, PhRMA’s Clinical Trials Principles in 2015 and updated to include diverse populations in 2020. The point is, that even with these efforts, there’s still a disparity in minority representation in clinical trials.
At some level, all these guidances aim to protect the patients and put in place procedures and recommendations that would lend confidence to the clinical trial process. But the word isn’t getting out. Given the seriousness of COVID and its global impact, perhaps these organizations need to coordinate together to assure minorities that they are protected in clinical trials, and perhaps more importantly, that they are an important player in the drug development process. Whether in the form or a statement or guidance, these global health organizations should lead the way in this effort.
Ultimately, however, the rubber meets the road with the pharmaceutical company and the Clinical Research Organizations who have to identify and enlist the patient volunteers. In this day and age, it’s pretty obvious that a good way to reach the right populations, you need to reach their leaders. Places of worship and community groups are good places to start. There’s a hodgepodge of coalitions and networks for nearly every minority community. Convince the leaders of these communities and ask them to convince their constituents. Outreach and engagement with these communities is the first step to building trust.
Then, ensure that the clinical trial investigators are from diverse backgrounds. This shouldn’t be too hard to do. Nearly every company today has Diversity and Inclusion programs so it won’t take much to expand this effort even more in carrying out clinical trials. It is well supported that individuals in marginalized communities fare better in the healthcare context when their personal health provider is a member of the group to which they belong. (See Kennedy et. al., Cook et. al. and Perloff et. al. ). And finally, to ensure that there is a robust pipeline of clinical trial practitioners and investigators, governments (state and local) can play a role by putting in place funding and educational initiatives (see Agadoa et. al.).
It’s not easy to win back trust. Especially when you’re in an industry that is one of the least trusted. But simple steps like community outreach, a diverse clinical workforce and funding to cover the cost of trials can chip away at the distrust…. until one day global clinical trials are truly global.
