Community Pharmacies Can Improve Clinical Trial Recruitment for Racial, Ethnic Minority Patients

Racial and ethnic minority patients have been historically underrepresented in clinical research conducted in US medical systems. This has resulted in far-reaching health inequities in the United States due to a lack of adequate data and research assessing the safety and efficacy of medical treatments on non-White populations.¹

These health inequities came to the fore during the height of the pandemic because of the stark contrasts observed in the data between the impact of COVID-19 on White versus racial and ethnic minority patients, and in particular Black patients. One data analysis published in the Annals of the American Thoracic Society in 2020 showed that Black patients were twice as likely as White patients to test positive for COVID-19.²

Specifically, the analysis showed that among 4413 individuals assessed, 17.8% tested positive for COVID-19, with 78.9% of the positive cases attributed to Black patients and 9.6% to White patients.²

“I think this really amplifies how pre-existing socioeconomic and health care disparities affect outcomes in the population. We already know that the common comorbidities that have been associated with COVID-19, such as hypertension and diabetes, disproportionately affect the Black community. So, it wasn't too surprising that COVID-19 seemed to more commonly affect Black individuals as well," said study author Ayodeji Adegunsoye, MD, MS, an assistant professor of medicine at the University of Chicago, in a press release.²

Before the pandemic, discussions around the social determinants of health (SDOH) that can lead to these health disparities within US medical systems were not as broadly addressed in medical communities, and in particular, in medical and pharmacy schools. According to Jacinda Abdul-Mutakabbir, PharmD, MPH, AAHIVP, assistant professor of clinical pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences at University of California San Diego, the reasons for these health inequities were not ones she generally considered during her pharmacy school education.

“When I was in pharmacy school, I didn’t really think about [SDOH] and health inequities. I thought about, ‘Okay, well individuals in minoritized groups are more likely to have these disease states because of these comorbidities,’ but I didn’t think of the reasons as to why this was something that existed,” Abdul-Mutakabbir said in an interview with Pharmacy Times.³

Since this time, individuals and organizations who have been or are beginning to track these data more effectively have come to the fore, with new regulations and requirements being developed to address SDOH across US medical systems.¹ The burgeoning role of the community health worker (CHW) has emerged as a key resource to aid in addressing SDOH in communities that have historically been medically underserved. The American Public Health Association (APHA) defined the CHW role in US health care as “a frontline public health worker who is a trusted member of and/or has an unusually close understanding of the community served. This trusting relationship enables the [CHW] to serve as a liaison/link/intermediary between health/social services and the community to facilitate access to services and improve the quality and cultural competence of service delivery.”⁴

In the pharmacy, many technicians have begun to work as the CHW, due to their preexisting skillset of solving patient challenges.⁴

“While many pharmacy technicians have for years been doing ‘community health work,’ solving patient problems surrounding medication access, etc, the utilization of pharmacy based CHWs are relatively new, within the last 6 or 8 years,” said Richard N. (Tripp) Logan, III, PharmD, vice president at SEMO Rx Pharmacies and SEMO Rx Care Coordination, in an interview with Pharmacy Times. “The formalized education and pharmacy CHW certification are much more recent, within the last 3 or so years.”⁴

Yet, as these issues are further addressed with new solutions developed as interventions for furthering the health care needs of patients facing challenges related to SDOH, one primary challenge remains: a lack of trust in medical institutions and systems among racial and ethnic minority patients, and in particular, among Black patients.¹ The underlying causes for this mistrust can be found in examples from history, such as the US Public Health Service (USPHS) Syphilis Study at Tuskegee in Alabama, a study that began in 1932 and wasn’t ended until 1972.⁵

“When I think about being a Black pharmacist myself, I understand the concerns of Black and other minoritized communities in respect to mistrust and distrust in the US health care system. I’ve grown up a Black woman in a Black family, so I understand things like the Tuskegee experiment and other factors that may play into why individuals may have a lack of confidence [in US health care systems],” Abdul-Mutakabbir said.³

However, the USPHS Syphilis Study at Tuskegee is an example of a medical study that can bring up significant pain and discomfort among many populations in the United States, which can cause this research to be less frequently discussed and addressed. However, to understand the source of concern and fear among communities who were impacted by this research, it is necessary for medical professionals to understand where those concerns come from so as to develop interventions that more effectively help these patients re-engage in a medical system that may conjure painful histories.

USPHS Syphilis Study at Tuskegee

Originally called the “Tuskegee Study of Untreated Syphilis in the Negro Male,” the trial began in 1932 under the direction of the US national health care organization USPHS working with the Tuskegee Institute. According to the CDC, the study is now referred to as the “USPHS Syphilis Study at Tuskegee.”⁵ The focus of the study was to record the natural history of syphilis, so investigators enrolled 600 Black men, 399 of whom were diagnosed with syphilis and 201 of whom did not have the disease.

A physician draws blood from a study participant in the USPHS Syphilis Study at Tuskegee, 1932. Image Credit: US National Archives

Notably, informed consent was not collected for any of the participants in this trial, although they were offered free medical exams, free meals, and burial insurance in exchange for participating in the study.⁶

Although the stated goal of the study was to determine how untreated syphilis impacts the human body, the planned primary method of investigating this impact was intended to be through autopsies conducted on study participants’ cadavers; however, the study subjects were not informed of this goal and were told instead that they were receiving treatment for “bad blood,” which was a local term used to describe several ailments, including syphilis, anemia, and fatigue.^6,7

After penicillin was discovered as a safe and reliable cure for syphilis, the majority of Black men with syphilis participating in the trial were not treated with penicillin.^6,7 At the time, the USPHS justified this decision because of their belief that Black people were broadly not interested and/or would refuse treatment for syphilis. For this reason, they called the trial a “study in nature” rather than an experiment, as they stated it was meant to simply observe the natural progression of syphilis within a community that would not seek treatment for the disease.⁷

Similarly, misconceptions of the sexuality of Black men plagued the design of the trial, as Black men were selected for this study due to held beliefs by the USPHS and study investigators regarding the heightened sex drive of Black men. In the late 19th and early 20th centuries, medical authorities believed that the genitals of Black people were overdeveloped, leading to heightened sexual appetites. For these reasons, the study investigators working under the control of the USPHS recruited Black men because they were believed to be more prone to sexually transmitted infections, making them ideal candidates, in their view, for this trial.^6,7

As trial recruitment went on, fears began to grow in local Black communities that the purpose of the clinical trial was to recruit Black men to the military. Because this was impacting recruitment numbers, investigators counteracted this by also examining Black women and children in the context of the trial as well to assuage their fears.⁷

As time progressed during the study and some patients stopped attending appointments, the USPHS hired a nurse to drive patients to and from appointments, provide them with hot meals, and deliver their medicines. In addition, to ensure access to the study participants’ cadavers after their passing, USPHS also began paying for patients’ funeral expenses as well.⁷

During the trial, the investigators also actively worked to ensure that study participants did not receive treatment for syphilis at outside medical offices. In 1934, study investigators provided nearby physicians in Macon County with lists of their trial participants and requests that they not be treated for syphilis at their facilities. This occurred again in 1940 when the investigators submitted this updated list to the Alabama Health Department.⁷

In 1941, many men participating in the trial were drafted for World War II; at this time, their syphilis was uncovered during the entrance medical exam. With the support of the USPHS, study investigators had these men removed from the army to ensure they would not be treated for syphilis, and potentially also ensure access to the men’s cadavers would not be obstructed for the purposes of the study.⁷

In 1947, penicillin was established as the standard treatment for syphilis, and by 1952, approximately 30% of the participants had received penicillin, despite interventions from the investigators to stop this from occurring.^6,7 After the Nuremberg Code was written in 1947 and the World Health Organization published their Declaration of Helsinki in 1964, both of which asserted international protections against human experimentation, the CDC—which had taken control of the trial from the USPHS during this time—stated their intentions to continue the study investigation until as late as 1969.⁷

The Tuskegee study ended in 1972 after the New York Times published an article outlining the experiment. By this time, only 74 of the study participants remained alive, with 128 patients having died of syphilis or associated complications, 40 of their wives having been infected, and 19 of their children having acquired congenital syphilis.⁷

The Aftermath: Mistrust in Clinical Research

Fifty years later, there are many descendants of study participants from USPHS Syphilis Study at Tuskegee who are still alive today. Given the recent nature of this trial and the US government’s involvement in its establishment and continuation while in full knowledge of the goals of the study, many Black patients in America continue to lack trust in medical institutions and the US government when considering the safety of participating in clinical trials.3 This continues to be especially true for Black communities in Alabama, such as in Macon County where the study was conducted, where the medical consequences of these experiments still live with descendants of study participants in their bodies in the form of congenital syphilis.⁷

Furthermore, some of the same interventions used to support participation in the USPHS Syphilis Study at Tuskegee remain the same types of tools that may be used to support patient recruitment and involvement in clinical trials today. For example, hiring a designated health worker to drive patients to and from appointments at a clinical trial site would be a potential way to address issues of access barriers to medical sites where clinical trials are being conducted. However, this same intervention was used to keep patients engaged in a trial that was actively working to ensure study participants would not be treated with a safe and effective medicine for their disease—so the barrier remains one of trust.^1,7

According to John 'Jake' Galdo, PharmD, MBA, the managing network facilitator at CPESN Health Equity and co-founder and CEO of Seguridad, Inc in Birmingham, Alabama, this issue of trust continues to plague organizations looking to recruit clinical trial participants for inclusion in research assessing the safety and efficacy of medicines for these populations, especially for clinical trials being conducted in Alabama.

“Greene County is one of the unhealthiest counties in the state [of Alabama], and 8 rural counties in Alabama don’t even have a health system. So there’s just a lack of health care [in these areas],” Galdo said in an interview with Pharmacy Times. “When we think about engagement in clinical trials, it’s not happening in Greene County—the clinical trial is happening in Jefferson County in Birmingham. So how is this county that is predominantly [of a] lower socioeconomic [status] and predominantly a non-White population going to engage in the clinical trial if they’re 2 hours [away from the trial site]?”

According to Logan, hiring trusted community members and leveraging that relationship to build trust in those communities may be a potential answer to this dilemma. Through establishing roles such as that of the CHW in pharmacies, trusted community members can become a resource for medical guidance and support through the challenges of the medical system, and especially in discussions around the potential benefits of participating in clinical trials and its potential value for furthering medical data to better treat racial and ethnic minority patients.

“That’s what our race and ethnicity research was really targeting: How can you leverage trusted members of the community to help get involved not only in clinical research, but in a registry,” Logan said during an interview with Pharmacy Times. “In community pharmacy practices, the employees there typically reflect their community, and we’re seeing a rapid growth of community health workers [in these areas].”

Logan explained further that for years, pharmacists have been one of the most trusted health professionals in communities, as pharmacies are often made up of their community members, especially in independent community pharmacies.

“That being an avenue to get underrepresented individuals more engaged in research makes a lot of sense,” Logan said.

Additionally, working to ensure there is further representation of racial and ethnic minority patients among the study investigation team is a beneficial tool as well to build that trust, according to Abdul-Mutakabbir.

“I did a pharmacokinetics and pharmacodynamics in vitro research fellowship under the tutelage of Mike Rybak, PharmD, MPH, PhD, [professor in Pharmacy Practice at Eugene Applebaum College of Pharmacy and Health Sciences at Wayne State University] in Detroit, and during this research fellowship, I at once saw the lack of women doing this in vitro research, the lack of pharmacists doing this research, but even more importantly, I saw a glaring lack of representation of Black women and Black women pharmacists doing that in vitro research,” Abdul-Mutakabbir said. “It was hard for me to navigate that process and be the first and only in that area within my fellowship program.”

However, Abdul-Mutakabbir noted that it remains very important for her to be present in her work as a Black woman engaged in infectious disease pharmacy and pharmacy research in her field.

“I know how important my representation is and how important it is for me to be able to show other Black women, ‘You can do this. This is a place that you can be in pharmacy,’ I took that very seriously,” Abdul-Mutakabbir said.

For Abdul-Mutakabbir, representation among the research team conducting the trial and recruiting racial and ethnic minority study participants is a key element of furthering opportunities to address gaps in clinical trial representation.

“When we think about the history of science, we think a lot about—and especially in the Black community—the Tuskegee experiment. We think about the lack of individuals advocating for the safety of Black subjects or minoritized subjects. When we think about health care in the United States, we think about sterilization. We think about just the mistreatment of minoritized individuals. Having people that look like those minorities [doing that research] is important, because it’s important that they serve as advocates,” Abdul-Mutakabbir said.

By having this representation among the research team, issues around the successful enrollment of Black patients in these clinical trials can be better addressed, as these individuals can make sure the recruitment and study process acknowledges the history that may be impacting racial and ethnic minority participants’ hesitancy to engage in clinical trials, according to Abdul-Mutakabbir.

“I am invested—because I am a Black woman, and I am an advocate,” Abdul-Mutakabbir said. “That’s the importance of having representation of these minoritized communities because we can hone in on those points. So when we give information, we can pay special homage to that and reassure individuals.”

The Role of Community Pharmacies

Community pharmacies can also play a role in increasing clinical trial recruitment of racial and ethnic minority patients as well, as the demographics of communities are often reflected in these pharmacies. To this end, the first step is implementing systems that support the reporting of the codified terminology for race and ethnicity in the patient data collection process in pharmacies, which can support the information gathering that will lead to identifying the correct patients for a clinical trial being conducted that would be a good fit for a patient of minority race and ethnicity.¹

According to Galdo, many pharmacy management systems still have ineffective terms included in the category for identifying the race and ethnicity of a patient.

“[National Council for Prescription Drug Programs (NCPDP)] has codified [race, ethnicity, and gender data elements],” Galdo said in an interview with Pharmacy Times. “We can appreciate that they update these data elements as well, most recently to include binary. Eventually, these terms also should evolve to say cis and trans—that would be a good thing. But the discrepancy is in the data standard, but what version of that standard is implemented in pharmacy management systems, and does the pharmacy management system mix data elements, such as the data element for race currently including ‘animal’ (the species data element) in some pharmacy management systems.”

Additionally, the federal government has mandated that the codified NCPDP terms for race and ethnicity be reported in federal COVID-19 programs to identify and address the impact of the COVID-19 pandemic on minority race and ethnicity patients.

“After all of our COVID-19 efforts, the federal government has mandated that we report this information, yet it’s still not happening. There are major chains out there that do not have the functionality to document race, ethnicity, or even weight in their pharmacy management systems,” Galdo said.

For Logan, this is a call to action for pharmacy professionals, as these requirements have already been mandated—the missing piece is effectively implementing these terms in pharmacy management systems so that pharmacy professionals can report data, as is federally mandated.

“Everyone is struggling with the same thing, but we need to push harder [to accomplish this],” Logan said.

According to Galdo, better adoption of the Choose My Pharmacy measurement system may be a potential solution to help address this call to action, as the system provides a quality measure for community pharmacies that is forcing this documentation to meet federally mandated ethnicity and data reporting requirements.

“Having a true quality rating system for pharmacies and having measures that evaluate these types of things will force adoption and push that forward,” Galdo said.

Another opportunity as well is ensuring this type of engagement is included in value-based arrangements, according to Logan.

“If through value-based arrangements and shared savings programs, health care providers and plans are being held accountable for SDoH/health equity-related measures, they ultimately should just push that out further to include pharmacy into those arrangements,” Logan said. “In the clinical trial world, there’s the ability to push some of that risk and reward down too so that there’s not just a carrot [of an incentive], but a stick. For me there’s only 2 ways [to do this]: One is pharmacy inclusion in value-based arrangements, and 2 is to have transparent stickers that say, ‘This pharmacy or organization is really cognizant of all these things and here is their score’ vs ‘This pharmacy is not cognizant whatsoever.’”

References

1. RxE2 and Enhanced Service Pharmacy Alliance (ESPhA). Community Pharmacy Demographic Trends: A Pilot Project on Collection of Patient Race and Ethnicity Data. [In email] Nashville, TN: ESPhA; 2023. Accessed May 31, 2023.
2. Hippensteele A. Black Individuals at Greater Risk of Contracting COVID-19. Pharmacy Times. July 10, 2020. Accessed May 31, 2023. https://www.pharmacytimes.com/view/black-individuals-at-greater-risk-of-contracting-covid-19
3. Expert: Representation of Black Populations in Pharmacy is Critical to Equitable Access to Vaccines, Care. Pharmacy Times. August 11, 2021. Accessed May 31, 2023. https://www.pharmacytimes.com/view/expert-representation-of-black-populations-in-pharmacy-is-critical-to-equitable-access-to-vaccines-care
4. Hippensteele A. The Role of the Pharmacy Technician Expands into Pharmacy-Based Community Health Worker. Pharmacy Times. May 3, 2023. Accessed May 31, 2023. https://www.pharmacytimes.com/view/the-role-of-the-pharmacy-technician-expands-into-pharmacy-based-community-health-worker
5. Office of Science. The Syphilis Study at Tuskegee Timeline. CDC website. Last Updated December 5, 2022. Accessed May 31, 2023. https://www.cdc.gov/tuskegee/timeline.htm
6. Heller J. AP Was There: Black men untreated in Tuskegee Syphilis Study. Associated Press. May 10, 2017. Accessed May 31, 2023. https://apnews.com/article/business-science-health-race-and-ethnicity-syphilis-e9dd07eaa4e74052878a68132cd3803a
7. McVean A. 40 Years of Human Experimentation in America: The Tuskegee Study. McGill University website. January 25, 2019. Accessed May 31, 2023. https://www.mcgill.ca/oss/article/history/40-years-human-experimentation-america-tuskegee-study