This article is adapted from a speech Ms. Brown-Friday delivered in June 2023 as President, Health Care & Education, of the American Diabetes Association. She delivered her address at the Association’s 83rd Scientific Sessions in San Diego, CA. A webcast of this speech is available for viewing on the DiabetesPro website (https://events.diabetes.org/live/25/page/186).
My journey to and with the American Diabetes Association (ADA) and to the position of President, Health Care & Education, has been a long and fulfilling one. My journey began early with the experiences I had growing up and eventually working in New York City. These experiences helped to form my views on diversity in clinical research. My parents, Joscelyn and Etheline Brown, insisted that a college education was not just a goal, but rather an expectation for me and my four siblings. I derived additional motivation from my Aunt Una, my father’s sister and a long-time licensed practical nurse who, in her 70s, pursued a bachelor’s degree in nursing.
In hindsight, it appears as though my eventual work with clinical research may have been my destiny from an early age. Understanding the importance of research, my mother enrolled me, as a child, in a Columbia University child development study. My memory of participating in this study is quite clear, as we took a train from Bedford Stuyvesant in Brooklyn to Washington Heights in Manhattan for numerous study visits over several years (Figure 1).
The author at two visits to the research facility for the Columbia University child development study in which she participated, on 10 October 1963 (left) and 8 October 1967 (right).
The author at two visits to the research facility for the Columbia University child development study in which she participated, on 10 October 1963 (left) and 8 October 1967 (right).
So, how did my journey eventually bring me to the ADA? In 1993, while attending graduate school at Hunter College in New York City and working per diem at New York Hospital, I was afforded the opportunity to serve on the ADA New York City chapter’s African American Committee, which was charged with creating a program called Diabetes Sundays. My friend Christopher Owens, who is the son of the late Brooklyn, NY, Congressman Major Owens and worked with my sister Necole, asked my sister if I might have the time to take his place on this committee, and, luckily, I did. After I completed graduate school, I had to ask myself what I wanted to be when I grew up. I pursued and in 1995 was hired for a position as the program coordinator for the landmark Diabetes Prevention Program (DPP) research study at the Albert Einstein College of Medicine. This time, I was a study coordinator instead of a study subject.
Later, in 1999, I was asked by the late Dr. Sanford Garfield, who was then the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) program officer for the DPP research study, if I would be interested in joining the National Diabetes Education Program (NDEP), a collaborative effort among the Department of Health and Human Services, the National Institutes of Health (NIH), and the Centers for Disease Control and Prevention. How could I say no? The words “diabetes” and “education” spoke to me. My DPP principal investigator at the time, Dr. Harry Shamoon, gave me the green light.
Still later, based on my performance with NDEP and again at Dr. Garfield’s behest, I was asked to join the NIDDK Advisory Council from 2005 to 2008. I am not sure how I kept my job at Einstein, but I guess I was able to juggle my responsibilities successfully at the DPP, which continues in my absence today in its long-term follow-up phase known as the Diabetes Prevention Program Outcomes Study.
After completing my obligation with NDEP in 2013, I kept a low profile, but they caught up with me, eventually. In 2016, I was encouraged to apply for a position on the ADA’s National Board of Directors. My term as a member at large ran from 2017 through 2019.
Are you seeing a theme here? I’m just minding my business as a good, God-fearing citizen, and they keep coming for me. Well, after taking 2 years off to focus on my son and his journey through high school to college, I was asked to return to the ADA’s National Board of Directors, first as President-Elect in 2022, and now as President, Health Care & Education, in 2023. So here I am today, quite humbled and honored to be in this position.
Minority Experiences in Clinical Research: A Sordid History
Most of my career has been spent in clinical research, and my professional experiences have molded my thoughts and actions with regard to the need for increased diversity in this realm. According to the National Institute on Minority Health and Health Disparities, “A clinical trial is described as research that evaluates the effects of intervention(s), including drugs, devices, surgeries, diets, behavioral approaches, and lifestyle interventions, on biomedical and behavioral outcomes” (1). However, certain drugs, devices, surgeries, and behavioral and lifestyle interventions are not always available to underrepresented minority communities in the real world. Imagine a place where you can, at least for a time, have access to these interventions—at no charge—by participating in clinical trials.
In 2022, the National Academies of Sciences, Engineering, and Medicine published a report titled, “Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups” (2). The report recognized that many individuals who face the greatest health challenges are less likely to benefit from the discoveries of clinical research because they are not adequately represented in trials. This lack of representation appears to be ongoing. A 2021 article by Gray et al. (3) in The Lancet documented that 53 drugs approved in 2020 by the U.S. Food and Drug Administration (FDA) were tested in trials in which 75% of the participants were White, even though racial and ethnic minority groups comprise 40% of the population.
There is also an unfortunate history of multiple instances in which research involving racial and ethnic minority groups was anything but beneficial to their participants or the groups to which they belonged. I provide here a few examples.
The Case of Anarcha Wescott
In a 2020 Endometrix article (4), Brittany Villegas told the story of Anarcha Wescott, a Black enslaved woman. In the 1840s, Dr. James Marion Sims (once deemed “the father of gynecology”) performed experimental gynecological surgeries on enslaved women. During childbirth, Anarcha Westcott experienced a vaginal tear, rendering her useless to her enslaver. Dr. Sims performed surgery on her, and many others, without the benefit of anesthesia. Villegas quoted Dr. Diedre Cooper Owens, who wrote that Black women’s bodies were described as “medical super bodies” that could withstand pain. As an enslaved person, Anarcha Westcott had no rights and, more than likely, could not refuse surgery. Dr. Sims performed such surgeries from 1845 to 1849 (5).
The Case of Henrietta Lacks
Many have probably heard the story of Henrietta Lacks and the HeLa cell line (6). A 2020 editorial in Nature (6) described Ms. Lacks’ untimely death at the age of 31 years from an aggressive cervical cancer. In addition to and in connection with the tragic death of this young woman, another travesty occurred. Samples of her cancer cells that were originally taken to aid in her diagnosis and treatment were handed off to a researcher without her consent (7).
The cells, known as HeLa cells, taken from Henrietta Lacks were found to have the extraordinary ability to survive and reproduce, making them, in some sense, immortal. The use of HeLa cells for research, without consent from Ms. Lack or her descendants, continued for several decades and led to discoveries in the fields of oncology, immunology, and infectious disease and, more recently, contributed to the development of a coronavirus disease 2019 (COVID-19) vaccine. Callaway, writing in Nature in 2013 (7), reported that NIH Director Dr. Frank Collins addressed the concerns of the surviving family, and the family eventually decided to allow the limited and consensual use of HeLa cells in research. They bestowed this consent despite never having had the opportunity to share in the financial benefits gained by researchers who had used the cells for decades.
The Case of the Tuskegee Syphilis Study
The Tuskegee Institute syphilis study is widely known for its unethical treatment of Black men who were deliberately left untreated for sexually transmitted infections in the name of research (8). The U.S. Public Health Service (USPHS) Untreated Syphilis Study was conducted at Tuskegee Institute between 1932 and 1972 to record the natural history of untreated syphilis (Figure 2) (9). Through this study, the USPHS followed the Black male subjects for 40 years. Although penicillin became available as a syphilis treatment about 10 years into the study, the medication was withheld from these men, who were also actively discouraged from seeking medical advice outside of the study. In addition to the mistreatment in the study, a formal apology for this atrocity did not occur until 25 years after the study had ended.
Timeline for the USPHS study of untreated syphilis at Tuskegee Institute. Adapted from ref. 9.
Timeline for the USPHS study of untreated syphilis at Tuskegee Institute. Adapted from ref. 9.
The Case of the Havasupai Tribe
In yet another example of the mistreatment of racial and ethnic minorities in research, Sterling (10) reported on the Havasupai tribe in Arizona and the unethical treatment of its members as recently as 1989. Concerned about increased risks for diabetes in their population, the Havasupai tribe requested help from a trusted Arizona State University anthropology professor to find out if they had the same genetic links to diabetes as other Native American tribes. The professor asked a colleague to assist in this research. The colleague, who had an interest in schizophrenia, had the study participants sign a broad consent covering the study of behavioral and medical disorders. The blood samples collected found no genetic link to diabetes, as had been found in other tribes; however, without obtaining additional consent, the specimens were also used for studies on schizophrenia, inbreeding, alcoholism, and other topics.
Exploring the Barriers to Increasing Diversity in Research
The history of unethical research practices involving racial and ethnic minorities illuminates the main barrier to increasing diversity in research today: justified and widespread mistrust of the medical community among racial and ethnic minority groups. To gain or regain trust, health care professionals and researchers must prove through action that we are indeed trustworthy (3).
In addition to pervasive mistrust, Gray et al. (3) also identify lack of access to and unavailability of appropriate clinical trials as significant barriers. Researchers must work to ensure that diverse communities are well informed about opportunities to participate in research studies that could be beneficial to them.
The barrier of eligibility is also extremely important. Researchers should review their eligibility criteria to ensure that these criteria do not inadvertently result in the exclusion of some diverse populations.
Enrollment practices can also result in the exclusion of individuals in some groups. Where recruitment is conducted will affect the cohort ultimately recruited. Thus, researchers must go into diverse communities and speak directly to them about their research projects. In doing so, researchers must use plain language and avoid medical jargon. They must hire and train staff that reflect the community they are attempting to recruit.
My own addition to this list is that we must recognize cultural differences as a potential barrier to increasing diversity in clinical trials. Researchers should acknowledge and become familiar with culturally based norms that could affect the interest and ability of diverse groups to participate in research. Starting with that acknowledgment may be a first step to building trust.
Federal Agencies’ Views on Diversity in Clinical Research
The importance of diversity in clinical research is supported by the federal agencies that set health policy in the United States. In October 2020, Dawn Corbett, the NIH’s inclusion policy officer, conducted a virtual seminar titled, “Including Diverse Populations in NIH-Funded Clinical Research” (11). In that seminar, she discussed the NIH’s policies on diversity and pointed out that women and minorities are to be included in all NIH-funded clinical research unless there is a “compelling rationale” for excluding them. Phase 3 clinical trials are to be designed to allow for the analysis of the influence of sex or gender and race and ethnicity on outcomes. In addition, results of these analyses are to be reported in trial pages on the ClincalTrials.gov website. NIH supports outreach efforts that further the recruitment and retention of women, minorities, and subpopulations of both.
For its part, the FDA recognizes that ensuring the inclusion of people from diverse backgrounds in clinical trials is key to advancing health equity. According to the FDA website, “Participants in clinical trials should represent the patients that will use the medical products” (12). One size does not fit all when it comes to medications. Knowing how people from diverse racial and ethnic backgrounds respond to a product in clinical trials can guide medication and dosing choices in clinical practice, just as the FDA mandates to consider issues such as age, sex, and pregnancy status.
The ADA’s Role in Increasing Diversity in Clinical Research and Care
The ADA helps to address the need for increased diversity in care and research through its #HealthEquityNow campaign (13). The campaign’s website underscores that inequity in health care “systemically harms people of color” and that “the COVID-19 pandemic and glaring examples of racial injustice are casting a bright light on an old problem in America.” I really must say that again: the COVID-19 pandemic cast a bright light on an old problem in America. The campaign website continues, “Health inequity is systemic and widespread. It contributes to worse outcomes and higher risk for diabetes and many other diseases. And it undermines the well-being of our most underserved communities.” These are simple concepts, but if not clearly stated and openly recognized, they can and will be forgotten.
Barriers Exist; How Do We Overcome Them?
First, we must admit to the atrocities and unfair practices that have created many of the barriers to increased diversity (3). We should be working within communities and forming community advisory boards (CABs) at the onset of our research projects. These groups can enlighten investigators on community needs and obstacles and advocate for community members’ participation.
In addition to developing and receiving training on concepts such as humility and implicit bias, we must also remember to learn the cultural norms of any populations we are attempting to recruit. In this effort, CABs can play an essential role. CABs can also help to develop recruitment strategies and culturally sensitive recruitment and project materials. Using multimedia platforms will help to spread the word about opportunities to participate in research projects by allowing a wider reach. Always remember, too, that the retention of your cohort begins at recruitment. Figure 3 summarizes these important strategies.
A pathway to overcoming barriers to increased diversity in clinical trials.
Being part of a research study should not add financial burden to study participants. For example, if transportation is an issue, use study resources to pay for taxi services or immediately reimburse for travel expenses.
Investigators should establish connections with communities, but also with government officials (e.g., the NIH) and industry, if appropriate, to share strategies for increasing diversity in research projects.
Work to have a diverse research team that reflects the populations included in the trials. This effort is not just for looks; diverse team members may share in the lived experiences of the participants, therefore making the trial more meaningful to both participants and the research team.
Exemplars of Clinical Trial Diversity
DPP Research Study
It could be that I am a little biased because I was Program Coordinator at the DPP Einstein site in the Bronx, but I think that study got it right when it came to diversity and inclusion (14). The DPP was designed to answer the question: does lifestyle or treatment with metformin prevent or delay the onset of type 2 diabetes? The positive results were important, but they were just a part of the study’s success story. From the beginning, this NIDDK-sponsored multicenter nationwide trial sought to enroll approximately half of its participants from racial or ethnic minority groups, and it did; 45.3% of the cohort were non-White. At the Bronx site, we truly embraced a diverse team as well. The staff were either immigrants themselves or first- or second-generation U.S. citizens. This team diversity assisted us in our conversations with participants during recruitment and surely with our retention. Figure 4 depicts flags that represent the ethnic diversity of the staff at Einstein.
Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study
I realize that there are other clinical trials on which I did not work that have successfully recruited and retained diverse study populations. I just was fortunate to work with two of the major ones: the DPP and GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) (15).
GRADE recruited people who had had type 2 diabetes for no more than 10 years. Eligible participants were on metformin therapy and had an A1C between 6.8 and 8.5%. Participants were randomly assigned to one of four FDA-approved and commonly used diabetes medications as a second agent after metformin. Of the 5,047 participants recruited from 36 research sites across the country, 19.8% were Black or African American and 18.6% were Hispanic or Latinx (15).
The GRADE research group began recruitment with diversity in mind. The goal was to have a cohort that was racially and ethnically representative of people with type 2 diabetes in the United States. And, again, the study staff was very diverse.
Getting It Right All of the Time
I do know that, when it comes to diversity, many studies get it right, but many others still do not. The NIH, FDA, and ADA all have policies related to diversity and the inclusion of underrepresented people in clinical trials. The policies are all good and important, but making them a condition of funding, when indicated, may help to ensure improved representation for people who are most often affected by diseases such as diabetes.
To summarize my key points, I am suggesting these marching orders to improve diversity moving forward. First, we must acknowledge the unethical research practices of the not-too-distant past. Forgetting these atrocities may lead to their repetition. Second, after acknowledging the past, we must recognize that we probably have unconscious and implicit biases that could affect how and where we conduct recruitment for our projects. Let us not let those biases dictate our actions. Third, we must develop and follow recruitment strategies that are based on how our research topics affect various populations. As medical researchers, we usually have an informed sense of which individuals and groups are more likely to be affected by a given disease. We must go into those communities and allow them the opportunity to contribute and benefit. Finally, the composition of our research teams can make or break our studies. We must carefully choose teams that reflect and can relate to the lived experiences of our potential study populations. Sharing common languages, ethnicities, genders, and other characteristics may enable study teams to begin rebuilding the broken trust that remains as a reminder of our less enlightened past—a past that was not that long ago.
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I have many people to thank for my successes. First, I thank my parents, Joscelyn and Etheline Brown. With their and God’s guidance, I became who I am today. I also thank my husband, Clement E. Friday, Jr., and our son, Vahn J. Friday, for their understanding and patience as I left home time and time again for meeting after meeting. I have always been happiest when they both were able to travel with me. I thank my sister, Patricia Hinds, who is a registered nurse like me and helped to light my path; my brother, Earl Brown, the politician who keeps me up-to-date on current events; my sister, Karen Brown, the teacher who always had a lesson for me; and sister, Necole Brown, a health educator who reminds me that I still have more to learn. Their support and guidance have always been immeasurable.
I also thank Dr. Harry Shamoon, my very first principal investigator, and Dr. Jill Crandall, my second. Thank you for trusting that I could walk and chew gum at the same time. Your support was, like that of my family, immeasurable. My first interviews at Albert Einstein College of Medicine were with Dr. Elizabeth Walker and Dr. Joel Zonszein. You had no idea who I was, yet you saw my potential. I also thank the late Dr. Sanford Garfield of NIDDK.
Finally, I thank my DPP study and GRADE team members for holding down the fort when I was away and for making this work so much fun. Colleagues at the DPP included Helena Duffy, Nadege Longchamp, Elise Zimmerman, Elissa Violino, Helen Martinez-Portalatin, Emelinda Blanco, Elsie Adorno-Nunez, Gilda Trandafirescu, Danielle Powell, and Norica Tomuta. At GRADE, my colleagues were Eni Xori, Gabriel Castillo, Susana Gonzalez de la Torre, Sally Duran, Hayley Estrella, Keisha Ballentine-Cargill, Stephanie Behringer, and Jennifer Lukin. My current team with the Multicenter AIDS Cohort Study/Women’s Interagency HIV Study–Combined Cohort Study includes Dr. Kathryn Anastos, Dr. Anjali Sharma, and Dr. David Hanna and management team members Wei Gao, Zalak Parikh, and Shirlyn Charles. I also thank the past and current members of the ADA’s National Board of Directors.