Houston, we have a problem! Diversity within the clinical research field is notably lacking. Why does this happen? 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 history 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 Syphilis 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 apologized 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. Looking at ways to reach out and work with local community centers, community leaders, and diverse populations honestly and authentically. Most importantly do not diminish their concerns or try to explain their hurt to them.
There are steps that have an impact on clinical trial participant diversity. Diversity in site staffing matters. Sites with diversity reflected through their study staff, nurses, and doctors are more likely to attract diverse populations. Reaching out to communities, by actually becoming a member of the community. Working 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 organizations that drive professional diversity, Diversity organizations such as The Society of Black Academic Surgeons, or Hispanic Neuropsychological Society (HNS). It is important to keep this conversation active, educate sites, and continue to analyze 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.
It is important to also provide education and training opportunities to sites regarding FDASIA (Safety and Innovation Act) Section 907, in which FDA stresses the importance of having diversity within research trials. Also refer 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.