For 40 years starting in 1932, the U.S. government conducted the “Tuskegee Study of Untreated Syphilis in the Negro Male,” one of the worst examples of abuse in research history. Outrage over the treatment of the Tuskegee participants continues to this day—as it should. But it should not prevent African Americans from participating in clinical research.
African Americans, Asians, and Latinos are significantly underrepresented in clinical trials. In the short term, that precludes patients from these communities from realizing the benefits of breakthrough therapies. Longer term, this lack of diversity can have a significant, detrimental effect on the health of entire communities. If study data do not include information on how well new medicines work for different groups, treatments might be less effective or have more side effects for underrepresented populations.
When we don’t encourage minorities to participate in clinical trials, we deprive them of the health benefits afforded to majority populations. Instead, we should find new ways to engage underrepresented populations in research, urge them to voice their concerns, and respond to them with respect and transparency. Those are among the goals of “Training Minority Clinical Teams: Getting New Quality Medicines to All Americans,” a unique program launched last year by Clinical Research Pathways and our partner, Morehouse School of Medicine.
Protecting participants and promoting diversity
The Tuskegee study was halted in 1972 after a government investigation determined that the research was “ethically unjustified.” The investigation also prompted critical changes to protect research participants, including requirements for stronger oversight and informed consent to ensure that participants understand the purpose and the risks and potential benefits of the research. These requirements have been strictly enforced ever since.
Twenty-five years after the end of the Tuskegee study, President Bill Clinton formally apologized to the surviving men and family members, as well as to the African American community. He also pledged that the nation would do more to bring the benefits of research to all Americans.
That cannot happen unless we increase participation in clinical trials among people from all races and ethnicities.
Studies show that there are many reasons minorities don’t participate in clinical research. Often, it’s simply because they are not asked or because their physician is not aware of relevant trials. The Clinical Research Pathways program tackles both obstacles. The program trains and mentors minority physicians to serve as clinical investigators. It also helps these physician investigators enroll patients at the point of care—in an environment where they are comfortable asking questions and expressing concerns.
We are optimistic about the program’s potential to increase diversity in clinical trials and extend the resulting benefits to minority populations. At the same time, we recognize that there are other barriers to diversity in research. But the Tuskegee study should not be among them. Instead, let’s use the lessons of that study to advance health equity.