The Tuskegee Study had, and continues to have, a devastating impact on the participation of African Americans in clinical research.
Public health researchers have cited it as a source of distrust among African Americans of the medical establishment, challenging efforts to slow the spread of HIV, contain tuberculosis and broaden preventive care.”
To refresh your memory, the Tuskegee Study was conducted by the U.S. Public Health Service between 1932 and 1972. The study observed the natural history of untreated syphilis.
As a part of the study, researchers did not collect informed consent from participants. They also did not offer treatment (found to be penicillin in 1943), even after it was easily available.”
The catalyst for ending the study was a 1972 Associated Press story breaking the news that there had been a 40-year non-therapeutic experiment on the effects of untreated syphilis on Black men in the rural south.
Undoubtedly, the legacy of the Tuskegee Study helps to explain underrepresentation of African Americans and minority participants in clinical research. Today, Black people comprise about 14 percent of the U.S. population but a contemporary analysis of 32,000 clinical trial participants in new drug trials in the U.S. in 2020 showed that only 8 percent were Black.
To better understand clinical trial participation, Charlyn Gomez, a medical student at the University of Maryland School of Medicine, designed a 45-question survey that sought to capture beliefs and perceptions related to medicine and research. The goal was to survey 100 people being treated for cancer.
From October 2023 to February 2024, a total of 97 patients who had completed radiation treatment at one of two Baltimore hospitals participated in the survey. Twenty-seven of the survey participants were Black.
There were no differences in age or insurance status between Black and non-Black patients. Black patients were more likely to be female, unmarried and have a lower household income. A similar percentage of Black and non-Black patients had previously participated clinical trials (16 percent versus 18 percent).
The survey found that more Black than non-Black patients agreed with statements such as:
- God determines wellness, not research (27 percent versus 8 percent).
- Research is designed to harm minority groups (20 percent versus 0 percent).
- Research could provide personal health information that they don’t want to know about (25 percent versus 4 percent).
- Their community wouldn’t gain anything if they participated in research (30 percent versus 6 percent).
It is also important to understand that representation is more than a metric. Diverse participation is essential for scientific validity and ethical research. Without diverse representation, the results may not fully apply to broader populations. Underrepresentation is said to have “led to researchers not getting enough patients for 55 percent of studies between 2008 and 2017.”
Research has demonstrated that many groups underrepresented and excluded in clinical research can have distinct disease presentations or health circumstances that affect how they will respond to an investigational drug or therapy.”
For example, in a study of patients with multiple sclerosis, the response of Black people to the therapy did not last as long as it did for White people.
Build Systems Rooted in Trust and Equity
Honoring the history of the Tuskegee Study and longstanding distrust means building systems rooted in trust, transparency and inclusion and mitigating common barriers to recruitment such as logistical, cultural, informational, financial and systemic.
There are proven strategies for reaching underrepresented communities such as community partnerships, multilingual materials, culturally relevant outreach and informed, patient-friendly communication. These are precisely the strategies OpenClinica Recruit used in a study with a goal to recruit obese black males between the ages of 25 and 65 living in rural South Carolina. To learn more, read the OpenClinica recruit case study below.
Obesity in African American Males in Rural South Carolina Case Study
PROBLEM:
The University of South Carolina launched an NIH-funded research study observing health issues in African American males and geographic factors contributing to obesity. The goal was to recruit obese African American males between the ages of 25 and 65 living in rural South Carolina that could potentially benefit from a weight loss program. During the first two years of a four year study, the researcher had only recruited three of 30 required participants.
SOLUTION:
OpenClinica Recruit’s patient engagement services and tools enabled the researcher to enroll the desired study population by utilizing various marketing tactics to target individuals based on ethnicity, demography, geography and indication. We deployed advertisements targeting African American males with a BMI greater than 25 in specific zip codes across multiple digital platforms and pre-screened interested participants for the study.
IMPACT:
The researcher was able to complete the study well ahead of schedule and accelerate their enrollment 10x-15x the speed using our patient recruitment services. They saw an instant increase in recruitment velocity and were able to better manage potential participants on our tech platform. Further, the researcher was able to reduce their overall study recruitment spend by three times through the use of more targeted advertising strategies.
At OpenClinica, we are committed to helping reverse the legacy of distrust in clinical trials. We help break down the barriers to clinical trial participation with:
- Geo-targeted recruitment campaigns for underserved populations.
- Mobile-first, accessible design that reaches patients where they are.
- Seamless, transparent eConsent that builds understanding and confidence.
- Real-time tracking of enrollment diversity metrics.
- Configurable workflows to align recruitment with local needs.
To learn more about OpenClinica Recruit helps clinical trials meet their diverse recruitment goals, click here.