Are We Really Addressing the Lack of Diversity in Clinical Trials?

While our industry has continued to raise awareness about the lack of diversity within clinical trials, actually addressing the issue remains our biggest challenge.

In the US, the picture is stark. 90% of clinical trial participants are white, despite 40% of Americans belonging to a racial or ethnic minority. And as we’ve seen throughout the COVID-19 global pandemic and in many other instances, this is having a major impact on our racial or ethnic communities.

For example, for Asthma sufferers, the most common treatment is a drug called Albuterol - which opens-up the medium and large airways in the lungs. However, a recent genomic analysis has revealed numerous genetic variants between how African-American and Puerto Rican children metabolise the drug, when compared to European American or Mexican children. The drug is significantly less effective for the former (who incidentally have the highest prevalence of asthma in the US) and there is a four-to-five-fold higher death rate from asthma among those groups.

This global issue isn’t anything new. Everyone in CRO understands the devastating consequences that a lack of diversity in clinical trials can have. So, what’s being done to overcome this challenge? Who’s implementing change?

To find out, I spoke to an expert from the industry: Tea Romero who’s the Portfolio Manager of ERT. With experience working at Covance and various other impressive CROs, Tea was well-placed to speak about this issue and the companies addressing it.

Here’s what she shared with me:

What do you think are the causes for a lack of diversity within the clinical trial space?

There is a lack of oversight in some cases. However, there is a deeper culture of distrust that the industry needs to tackle head-on.

Due to a very sketchy past including many high publicity cases. For example, in Mississippi, the Tuskegee experiment took place from 1930-1970 and the abuses were horrific and led to long, painful Syphillis deaths. Despite penicillin becoming a standard treatment in 1947, the trauma the community experienced is still felt today.

There are many more examples of abuse. These abuse cases cannot be forgotten. And while the government has apologised, the damage is done.

To counter this negative perception, it is important for the companies involved in research to face our past with honest reflection. Include diverse populations at all levels of the conversation and listen to what the community says. Look at ways to reach out and work with local community centres, community leaders, and diverse populations honestly and authentically. Most importantly do not diminish their concerns or try to explain their hurt to them.

What proactive steps can the industry take to avoid this?

We need to reach out to communities by actually becoming a member of the community. We must work toward creating high visibility within the community - providing inclusion/exclusion criteria that allow for more diverse participation whenever possible and simply offering transportation to and from appointments has shown to increase diversity.

I also suggest working with the organisations that drive professional diversity, like The Society of Black Academic Surgeons or Hispanic Neuropsychological Society (HNS). It is important to keep this conversation active, educate sites and continue to analyse studies for diversity outcomes.

All of us in research can look at ways to reach and work with local community centers and provide technology to help include patients who may not join a traditional trial. We can work with patient advocacy groups and mandate diversity within companies' SOPs' internal practices.

What steps have you seen taken within your own company and previous employers?

Diversity in staff matters. Sites with diverse study staff, nurses and doctors are more likely to attract diverse populations.

So, we’ve educated our sited and reached out about the FDASIA (Safety and Innovation Act) Section 907, in which FDA stresses the importance of having diversity within research trials. We’ve referred to the recent November 2020 enhancement of Diversity of Clinical Trial Populations- Eligibility Criteria, Enrollment Practices and Trial Design Guidance for Industry.

Many sites and study staff members are not aware that diversity guidance comes directly from the FDA. Explaining to sponsors and CROs the risk of not having a plan in place to increase participation diversity. At the end of the day, non-compliance could impact FDA approvals. Scientists cannot make determinations on efficacy if diverse populations are not including in the trial research.

I found Tea’s response to my questions fascinating and it’s clear that the CRO space understand the importance of diversity within clinical trials. As a global headhunter withing the space, I’ve seen impressive initiatives implemented from multiple companies trying to influence change.

For example, Bristol Myers-Squibb has collaborated with GRYT Health to produce the Patient Advocacy Exchange, which is a platform for advocacy groups, industry leaders and patients to share meaningful information and forge relationships. Spaulding Clinical Research hosts an open house for participants in clinical trials to become educated during the process. Meanwhile, Biorasi encourages diversity amongst its staff and has extended its patient consent process to provide vital medical education for harder to reach patients.

While all this is positive, the issue remains a complex one, with many moving parts including cultural and historical factors that will be hard to change. If you’re working in the space, I’d love to know how your company is addressing diversity in clinical trials. Please feel free to give me an email via Elisabeth.Edmonds@lifesci-cm.com.

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