Clinical trials are the foundation for innovation in medicine: They provide a controlled setting to test new drugs and medical procedures, allowing researchers to determine efficacy. But they’re also fundamentally flawed.
That’s because the majority of clinical trials are conducted with a homogenous group of subjects — consisting mostly of white participants, and historically, mostly white men. The genetic and biological variation represented in different races and genders is often left out of the testing process, resulting in drugs that might be less effective, or have unknown side effects, for a large percentage of the population.
Researchers have been trying to fix this problem for a while. In 1993, Congress passed the National Institutes of Health Revitalization Act, a law compelling federally funded research projects to include women and minorities in their trials, and to disclose the gender and race of participants in a research summary. But two decades later, things still look pretty white.
As a 2014 study found, fewer than 5 percent of respiratory trials and only 2 percent of cancer trials include enough minorities to generate reliable information. According to figures released by the FDA and the Society for Women’s Health Research in 2011, only 5 percent of clinical trial participants are African American and an even smaller 1 percent are Hispanic.
Recently the U.S. Food and Drug Administration invigorated its efforts to transform the subject pool in clinical trials, even naming 2016 “the year of diversity.” A number of research institutions are also spearheading initiatives to diversify testing, with the National Center for Bioethics in Research and Healthcare at Tuskegee University leading the way. The university recently announced a partnership with Eli Lilly and Company to study the participation of African Americans in clinical trials.
Diversifying clinical trials is a fitting project for Tuskegee, a place synonymous with the kind of ethical violations that have dissuaded minority populations from participating in the past.
Every first-year medical student learns about the Tuskegee syphilis study conducted by the U.S. Public Health Service from 1932 to 1972, in which a group of black men with syphilis were given placebo treatment and monitored while their health declined. The study aimed to look at the long-term effects of the disease. Other ethically dubious data collecting, including eugenics experiments, were conducted using subjects from the historically black university.
But, according to Rueben Warren, the director of the university’s National Bioethics Center, the school’s legacy is part of what makes the initiative important.
“The name Tuskegee has such power around research,” says Warren.
Though many minority groups are underrepresented in clinical trials, Tuskegee’s initiative will look solely at the barriers to African Americans participating in research. Warren says that research shows that African Americans aren’t unwilling to participate in human subject studies, but they are historically much more cautious.
Rather than working to convince African Americans to participate in clinical trials, Warren thinks that the research community needs a paradigm shift in how they approach study design. That’s why he’s working with black organizations — including faith based groups, health groups like the African American Health Professional Organization, and civic groups like the NAACP — to survey black populations and better understand their responses to research.
“We’re trying to better understand why there is a lack of participation,” he says. Then, once that phase is completed, the project will focus on how research organizations can develop policies to demonstrate trustworthiness. “For years the barrier of trust has been placed on the participant,” says Warren. “If we can prove ourselves trustworthy [as research institutions], I’m convinced that trust will be forthcoming.”