UF Research has recently awarded a grant to address racial disparities in clinical trials of treatments for some of the nation’s most prevalent chronic diseases, like diabetes, hypertension, stroke, heart and kidney disease.
Racial Disparities in Research
“The diseases affect more than 50 million Americans, with the highest rates and worse outcomes observed among Black Americans for whom these diseases account for 40% of all deaths,” said Dr. Azra Bihorac, a principal investigator on the project. “Although it is imperative that clinical trials for new therapies include Black participants, the data does not support that mandate. In one major trial of a new class of medications for diabetes, only 4% of the 102,000 participants were Black.”
Diversity among clinical trial participants is necessary in order for research findings to be accurate and generalizable to the population. Despite national efforts to decrease the racial, ethnic, and gender disparities in clinical trials, women and minorities have been historically under-represented, even for conditions that disproportionately affect them. There is a distinct lack of racial diversity in clinical research and many trials don’t report data on race or ethnicity distribution. The implicit racial bias among healthcare workers and lack of diversity in the research workforce are insufficiently studied barriers to racial diversity in clinical trials and research generalizability.
With a goal of achieving racial equity in clinical trials at UF, this project will involve an urgent assessment of racial diversity among clinical trial participants and the research workforce. Following the assessment, we will apply intervention strategies to address implicit biases of race, ethnicity, and gender in clinical research. The objective is to ultimately lead to equitable, patient-centered clinical research at UF for all.
Women Researchers to the Rescue
The principal investigators of the grant are Drs. Crystal Johnson-Mann, Azra Bihorac, and Della V. Mosley. This all-women team of researchers has top-notch expertise in clinical studies, nephrology, obesity, surgery, and psychology. The complementary skillset allows them to address these issues of disparities in research from the perspective of vulnerability and compassion. Their personal experiences of under-representation in medicine are a driving force behind their desire to create more equitable research.
Dr. Crystal Johnson-Mann, Assistant Professor in Surgery, has clinical expertise in Bariatric Surgery for patients who are overwhelmingly affected by chronic diseases due to obesity. She is currently the only Black woman surgeon at UF and is involved in advocating for Black women physicians on a national level.
Dr. Azra Bihorac, lab director of PRISMAp, is a Professor of Medicine, Surgery, and Anesthesiology with career-long research in critical care, surgery, and nephrology while being an activist for gender equity in medicine. She is a survivor of the Bosnian genocide as a religious minority and was a refugee in Turkey and the United States.
Dr. Della V. Mosley is an Assistant Professor in Psychology with expertise in qualitative methodology. As a scholar of Black psychology, racism, and antiracism interventions, she has published, presented, and educated extensively on these topics.
PRISMAp researcher, Julie Cupka, has learned about the immediate need for addressing racial disparities through working with Dr. Bihorac and other research collaborators who advocate for equality in medicine. Cupka said that she’s influenced by Dr. Johnson-Mann’s determination to make positive changes and “that’s something that she’s very passionate about because she’s a bariatric surgeon who works with patients with obesity, diabetes, hypertension, and kidney disease, which disproportionately affect Black patients.” She summarizes the motivation behind this project as knowing that healthcare workers are “taking care of all these patients who are not really represented in clinical trial research. What should we do?”
The Action Plan
In order to understand and address the issue of underrepresented groups in clinical research we have three aims for the project:
- Aim 1 — Identify racial and gender disparities among participants in obesity, diabetes, stroke, hypertension, heart and kidney disease clinical trials at UF and nationwide.
UF researchers will perform a systematic review of all clinical trials related to these diseases in the last 10 years in the U.S. The review will evaluate racial, ethnic, and gender representation of the trial participants. This will show how different demographic groups are represented (and under-represented) in clinical trials on a national level.
Then, we will review the racial, ethnic, and gender representation in trials at UF to see how we must improve and compare it to the national statistics.
- Aim 2 — Assess the diversity of the clinical research workforce and barriers to inclusive trial recruitment at UF.
We will conduct focus groups and interviews among trial participants and the research workforce to assess their perceptions of implicit bias and other barriers to recruiting diverse participants. This includes an Implicit Association Test (IAT) of the clinical research employees to assess unconscious associations with race, ethnicity, and gender.
Additionally, under-represented subgroups of participants will have their own focus groups to bring in a deeper understanding of those patients’ perceptions of barriers to equitable research.
- Aim 3 — Develop and evaluate implicit bias training for clinical research workforce at UF.
We will develop a structured training for the clinical researchers to reduce their implicit bias. This will include creating awareness of fundamentals behind implicit bias and microaggressions in the research space. Researchers developing the training will consider input from patients’ focus groups in Aim 2 to develop our training in a way that delivers patient-centered improvement.
We will determine the effectiveness of the training with pre- and postintervention assessments. Training sessions will take place on a recurring basis, as we work with UF College of Medicine to promote them as part of clinical research training requirements.
Urgency of the Solution
Disparities of race, ethnicity, and gender in clinical trials weaken the accuracy and reliability of research. These problems can result in inferior medical care for patients in marginalized groups, an issue which carries devastating health and social consequences.
There is minimal research on real-world applications of implicit bias and cultural sensitivity training to improve diversity among clinical trial participants. We hope that we can provide insight into better mechanisms for understanding and correcting biases. Projects similar to this one must take place around the nation and the world to address the immediate need for minimizing disparities in clinical research.