Without greater participation from Black Americans in clinical trials, researchers will continue to struggle to fully understand why certain diseases affect Black communities differently. Increasing representation in clinical research is key to developing treatments that are safe and effective for everyone.
Studies show Black Americans continue to distrust medical research and clinical trials, likely stemming from the lasting legacy of the infamous Tuskegee Syphilis experiment, which ended in 1972. The study exposed deep ethical violations and led to major reforms in research ethics, including the introduction of Institutional Review Boards (IRBs) and protections for informed consent.
This issue can feel like a paradox: many of us remain wary of clinical trials because of historical abuses and inequities in healthcare. At the same time, representation in research is critical to ensuring new treatments work effectively for us.
We spoke to experts who’ve looked into disparities in clinical trial participation to better understand what’s holding us back from participating in potentially life-saving research.
What the Research Shows About Black Participation in Clinical Trials
In the study, senior author Dr. Neil Powe, a professor of medicine at Johns Hopkins School of Medicine in Baltimore, and his colleagues conducted a random survey of 717 outpatients at 13 cardiology and general medicine clinics in Maryland. Thirty-six percent of participants were Black, and the rest were white.
After an in-depth explanation by a physician (either Black or white), each participant was asked to enroll in a mock trial of a cardiovascular drug.
Key findings of the study included:
- 27 percent of Black respondents were willing to participate in the mock trial vs 39 percent of white respondents.
- 72 percent of Black participants believed doctors might use them as “guinea pigs” without consent, compared with 49 percent of white participants.
- 35 percent of Black respondents thought doctors might ask them to participate even if it could harm them (vs 16 percent of whites).
When the element of distrust was removed from the equation, the proportions of Blacks and whites willing to enroll equalized to about a third of those sampled in both racial groups.
Why Some Black People Distrust Clinical Research
Our hesitancy to participate in clinical trials is widely thought to stem from the legacy of Tuskegee and other such research.
The government-sponsored Tuskegee Study enrolled several hundred poor, Black sharecroppers, telling them that they would receive drugs to treat their syphilis infections. But lifesaving drugs were purposely withheld so the “natural” course of the disease could be observed. The experiment ran for 40 years but was shut down after a leak to the press in 1972.
This study has caused longstanding mistrust of the medical system among the Black community and has kept many of us from participating in any form of research, as we fear we’ll be harmed.
“We found that minorities are 200 percent more likely to perceive harm coming from participating in research,” Dr. Powe said. While previous studies have shown that Black Americans and other minorities are less likely to be enrolled in clinical trials, Dr. Powe’s study helps explain why.
“This study provides direct evidence that distrust of researchers explains the lower participation of Blacks in cardiovascular prevention trials research,” said Dr. William Cunningham, a professor of medicine and public health at the UCLA School of Medicine.
Current Efforts to Get More of Us into Clinical Trials
Project IMPACT (Increase Minority Participation and Awareness in Clinical Trials) is a program from the National Medical Association (NMA), which represents Black physicians and their patients.
“This provides a database to support what we think is going on with respect to concerns of the minority community,” said Dr. James Powell, principal investigator of Project IMPACT. “Mistrust comes up not only [concerning] clinical trials, but also with respect to interacting with the medical establishment,” Dr. Powell said. “This leads to people not seeing a physician when they really need to.”
Black Americans tend to be underrepresented in clinical trials that are responsible for many advances in medicine. This discrepancy is particularly unfortunate because not only do Black Americans suffer disproportionately from many health conditions, but they often experience illnesses differently and respond differently to medications, making race-specific trials even more crucial, the researchers noted.
How to Build Better Clinical Trial Trust
The good news is that there are ways to remedy the situation and get more of us involved in clinical trials.
One method Dr. Powe recommends is improving the interaction between researchers and patients. “Physicians and researchers should be taking the time to talk to patients and communicate with them, explaining the risk of being involved in medical research and dispelling myths about participating in research,” Dr. Powe said. “It’s hard to do in a busy medical environment today, but necessary.”
Academic medical centers also need to build relationships that improve trust with the community, even including community leaders in designing research studies.
Lastly, Dr. Powe mentions that patients tend to trust physicians of the same race. “One big issue is that there are not enough minority physicians, so that’s a societal remedy we all have to think about,” he said. Some 12 percent of the U.S. population is Black, but only 4 percent of physicians are Black.
In recent years, federal agencies and research institutions have increased efforts to improve diversity in clinical trials. The Food and Drug Administration (FDA) has issued guidance encouraging drug makers to enroll participants who better reflect the populations affected by the disease.
Final Thoughts
Increasing participation in clinical trials can help researchers better understand how diseases affect different communities and ensure new treatments are tested across diverse populations. But first, we’ll need to overcome our fears and put our community first to make a bigger impact in medical research.
Find out more about clinical trials on BlackDoctor at our Clinical Trials Resource Center.
SOURCES: Neil R. Powe, M.D., M.P.H., M.B.A., professor, medicine, Johns Hopkins School of Medicine, Baltimore; William E. Cunningham, M.D., professor, medicine and public health, UCLA School of Medicine, Los Angeles; James Powell, M.D., principal investigator, Project Impact Program, National Medical Association
