Community pharmacies are ideal locations to identify and recruit underrepresented patients for clinical trials.
Patients who are racial and ethnic minorities have been historically underrepresented in clinical trials, which has had lasting impacts on health equity and health outcomes.1 However, the community pharmacist is an ideal resource to improve the recruitment of diverse populations, according to new research from the Pilot Project on Collection of Patient Race and Ethnicity Data. The project highlights that the pharmacy reflects the diversity of the community, and the pharmacist can effectively collect demographic information to support clinical trial enrollment.
“Community pharmacies across the country are participating in referring and enrolling patients in clinical trials and dispensing investigational drugs, with a primary driver of achieving health equity in clinical trials,” said Gerald E. Finken, the chief executive officer at RxE2, Inc., Fargo, North Dakota, in an interview with Pharmacy Times.
But trial representation is still not equal. According to the FDA-led 2020 Drug Trials Snapshots Summary Report, more than 12.5 times the number of participants in clinical trials are White (75%) compared to Asian (6%). Additionally, only 8% of patients in clinical trials were Black, and 11% were Hispanic.1
Recently, investigators collected data (as part of an RxE2-sponsored 8-week Pilot Project on Collection of Patient Race and Ethnicity Data) to understand the feasibility of documenting health-related patient race and ethnicity information at the community pharmacy. If community pharmacists can easily collect these data, then they can be an effective resource to promote clinical trial diversity.
During this pilot project, investigators asked pharmacists at 5 geographically diverse community pharmacies to collect data on race (American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, Other, or White) and ethnicity (Hispanic or Latino vs Not Hispanic or Latino). Patients provided this data by filling out a patient intake form at the pharmacy.1
The study shows that it is feasible for community pharmacists to collect race and ethnicity data based on 56,723 patient responses. At baseline, 2259 patients (4.22%) filled out the form to document race; 1093 (2.04%) patients documented race and ethnicity. After the 8-week intervention, 3852 patients (6.79%) documented race data; 2504 patients (4.41%) documented race and ethnicity.
Specifically, a participating Ohio pharmacy had more than a 2500% increase in patients who provided their race and ethnicity data. Pharmacists at a pharmacy in Mississippi incentivized patient responses with a prize drawing, using a text-based digital collection process to facilitate data collection, and a Miami pharmacy also succeeded in getting patients to document demographic information.
The project had slow momentum at a Louisiana pharmacy, but a rural Texas pharmacy increased patient demographic documentation by offering forms written in Spanish, catering to the majority Spanish-speaking population.
During the study, investigators also compared race and ethnicity data collected at the pharmacy with US Census Data. It confirmed that the racial and ethnic makeup of the populations who shop at these community pharmacies reflects the diverse makeup of people who live in the surrounding area. That is, the community pharmacy reflects the diversity of the surrounding community.
“You don't get more local than community pharmacies,” said Tripp Logan, III, PharmD, vice president at SEMO Rx Pharmacies and SEMO Rx Care Coordination, in an interview with Pharmacy Times. “And pharmacy staff are from that community.”
A factor that may contribute to a lack of diversity in clinical trial participants is a generational mistrust in clinical research due to a history of patients being used for clinical research either without their consent or full information as to the purpose of the study.2
For example, in the 1932 US Public Health Service Syphilis Study at Tuskegee (Tuskegee), Black men were enrolled in a study to determine how untreated syphilis impacts the human body; however, the study participants were not informed they would be denied lifesaving treatment when it became available.
With studies like Tuskegee still present in the minds of many Black patients, there continues to be a generational mistrust of clinical trials and a wariness toward physicians.2 And it does not help that the doctor is, historically, the one to discuss clinical trial enrollment with the patient, Finken said.
Today, the medical field is looking to pharmacists to help address this issue; the FDA released draft guidance in April 2022 requesting the industry to promote diversity, equity, and inclusion (DEI) in clinical trials, according to Finken. This focus placed on the industry by the FDA provides a great opportunity for community pharmacies to get involved in clinical trials and allows the pharmacy to collect demographic data and empower underrepresented populations to enter clinical trials in a way that other healthcare practitioners cannot.
For instance, patients do not need to schedule an appointment with a community pharmacist, which makes them an accessible source to discuss clinical trial enrollment with patients, according to Finken. He added that the relationship between the pharmacist and patient is formed over many years, so leveraging that relationship is a natural way to build trust and promote diverse clinical trial recruitment. Pharmacists can also help patients assess risks and benefits.
“Who better to speak with than the medication experts who also understand their patients and their community?” Finken said.
Finken emphasized that the community pharmacist has been working to solve issues associated with diversity in clinical trials—like addressing social determinants of health (SDOH), patient misunderstanding, and patient mistrust—well before the FDA created the guidance. Had this not been the case, “[independent pharmacies] would not still be in business,” Finken tells Pharmacy Times.
However, the expert warned that demographic data collection is not necessarily associated with improved clinical trial enrollment. Although technology companies may use it to locate sites for trial enrollment, patients may still not feel safe going to these trial sites to participate because of mistrust. In such cases, the community pharmacist is an established and trusted resource that can discuss patients' personal needs and safety concerns while helping them make informed decisions.
As diversity in clinical trials increases, this may help to improve trust in the entire health care system for minority patients, explained 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, in an interview with Pharmacy Times.2 With more representation in clinical trials, the data can better serve the healthcare needs of minority patients, which can improve health outcomes and support more widespread benefits from innovative therapies.1
Being able to point to data showing that patients of color experienced benefit from therapy is a significant bolster for trust not only in that medicine but potentially also in the healthcare system overall.
Challenges in Data Collection
During the 8-week Pilot Project, pharmacists experienced some challenges in collecting data, whether it was staffing/time constraints or awkward conversations with patients.
“Patients with complex conditions, particularly those that are socially vulnerable, are [also] extremely challenging to engage and keep engaged with the broader healthcare system,” Logan said.
To ameliorate these issues, most pharmacists agree that point-of-sale support could make it easier to document health-related patient race and ethnicity information. It could be wise to have different procedures for collecting patient intake/data as well.1
Standardizing the terminologies and qualifications for race, ethnicity, and other social determinants of health (SDOH) could also advance health equity, said Jake Galdo, the managing network facilitator at CPESN Health Equity and co-founder and CEO of Seguridad, Inc. in Birmingham, Alabama, in an interview with Pharmacy Times.
Data standards—which include the “methods, protocols, terminologies, and specifications for the collection, exchange, storage, and retrieval of information associated with health care applications,” according to the authors of Patient Safety: Achieving a New Standard for Care3—
can make health equity-related information (i.e., race and ethnicity) translatable across healthcare industries and sectors, Galdo explained.
“[It’s] a Rosetta Stone for health equity work,” Galdo said.
A health equity data standard would also allow people who conduct clinical trials to quickly identify and connect diverse patients to resources based on SDOH.
“It's a win for patients with increased access to specialized care that may not have been available previously, and it's a win for clinical trial sponsors to have trials that represent the diversity of the United States,” Galdo said.
Further, standardized SDOH documentation could improve the chance that a pharmacist receives reimbursement from the Centers for Medicare and Medicaid Services through one of its value-based programs. Without standardized data, there is no proof of the value of the pharmacist in addressing health inequities—even if the pharmacist is addressing them, Galdo explains.
Community pharmacies can also address SDOH and improve health equity outcomes by coordinating care for vulnerable patients and community members, Logan said. To this end, a growing number of community pharmacies have added SDOH specialists and community health workers to their staff to facilitate these efforts.
Regarding next steps following the pilot project findings, Logan noted that the focus will be on education and scaling results.
“[We need to] educate decision makers on the value that can be realized by utilizing community pharmacy relationships to solve very personal, local, complex problems, many of which are socially driven and not clinical,” Logan said. “[Additionally, we need to] scale these efforts quickly to help as many patients locally as possible.”
Editor's note: this article was updated from its original version, titled Community Pharmacy Can Help Solve National Health Equity Challenges Facing Clinical Research, on October 7, 2023.