Ideally, participants in clinical trials reflect the composition of the general population. Given the diverse nature of America’s population, we would expect clinical trials to reflect this diversity. However, in reality, minority groups are often underrepresented in study participant populations. This disparity is well documented and rooted in mistrust that certain minority communities have in healthcare systems due to systemic and institutional racism.
There is a historical basis for this lack of trust due to experiments that were conducted within minority communities against their will or without their knowledge. And so, before we can understand how to increase diversity in clinical trials, we need to better understand where this mistrust originated.
One of the most well-known and egregious examples of this abuse is the Tuskegee syphilis study. From 1932 to 1972, the US Public Health Service targeted and monitored uneducated Black men in the South. Even though a treatment for syphilis was available, the treatment was withheld in order to witness how the disease progressed. This, of course, had a profound effect on the trust the Black community has in public health institutions.
Another example of this abuse can be found with the story of Henrietta Lacks. Lacks was a Black woman who was diagnosed with an aggressive form of cervical cancer in 1951. While examining and treating her disease, doctors at the Johns Hopkins Hospital in Baltimore, Maryland, took samples of her cancerous cells. Then, without Lacks’s knowledge or consent, the doctors gave some of that tissue to a researcher. In the laboratory, the researcher discovered that these cells had an astonishing capability to survive and reproduce. The cells were widely shared among scientists. Research done with these cells has been involved in discoveries in many fields, including cancer, immunology, and infectious disease. Even today, they were recently applied to research for vaccines against COVID-19. But for 70 years now, doctors and scientists never once asked Lacks or her family for consent – even as they publicly used her name, gave her medical records to the media, and published her cells’ genome online.
Unethical research has also generated mistrust in Native American communities. For instance, the Havasupai diabetes project in the 1990s began with researchers at Arizona State University collecting DNA samples from members of the Havasupai tribe. The researchers were looking for gene variants associated with diabetes, a widespread disease among the tribe. Despite the spiritual significance of blood to the tribe, participants consented to give their blood because they believed they would receive a cure for diabetes. In 2003, the Havasupai discovered that their blood had been used not only to study diabetes but also to research schizophrenia, tribal origins, and any degree of inbreeding. This led to the Havasupai banishing Arizona State University employees from setting foot on their reservation and a lawsuit. In 2010, the University’s Board of Regents settled the lawsuit by paying $700,000 to the tribe, returning the blood, and providing other forms of assistance.
The distrust stemming from abuses like these in minority communities leaves people wondering why they should volunteer to participate in clinical research. They need to know they can trust researchers to do what they say they are going to do with their health information. They also need to know that once clinical trials are over and a drug goes to market, they will be able to take advantage of the medication.
Increasing diversity in study participant populations now comes down to making sure underrepresented people understand at the outset of a trial that they are going to be treated the same as everyone else. Sufficiently communicating everything that goes into the informed consent process could help provide this reassurance. This connects to the workforce portion of clinical trials as well: when you have people of a certain culture or who speak a certain language entering a clinical trial site, they need to see people they are familiar with. It makes people feel more comfortable to see others from the same background, the same culture, the same locality. And that builds trust.
Many cultures have remedies that matter to them and have shown benefits within their community. It is important that people caring for these patients understand the importance of these remedies and not simply instruct someone to stop using them. This can have a huge impact on patients wanting to return to that facility or see that doctor again.
Some companies have had success in addressing the disparities in clinical trials by using home health agencies to conduct appointments at participants’ homes. When you have certain patient populations more susceptible to or with a higher prevalence of developing certain diseases, and they also happen to be low income, getting to where they need to go while also fighting comorbidities is a barrier. Bringing trials to the home can go a long way toward encouraging certain people to participate in a study – they are in their comfort zone and around people they know.
If we want to achieve better outcomes and health equity for historically underserved populations, it is imperative that we continue to focus on increasing the participation of minorities in clinical research. People’s lives depend on it.