Clinical trial enrollment is a major challenge for clinical researchers and sponsors.
It’s not easy to establish a presence in a community, build a relationship with potential patients, then enroll them into experimental research. Even if it were, researchers would need to have a footprint in every community possible to ensure a clinical trial’s patient group was representative of the wider patient population.
However, pharmacies possess a distinct advantage due to their physical presence and the intimate relationships their staff share with patients. In this article, we delve into the potential of leveraging pharmacies to enhance clinical trial enrollment.
Solving Critical Recruitment Challenges: The Power of Pharmacies
Nearly 90 percent of Americans live within five miles of a pharmacy, writes Timothy Aungst at The Digital Apothecary, where they frequently interact with pharmacy staff, often more than with their primary healthcare providers.
When aiming to engage the broader American population, leveraging local pharmacies becomes an evident choice due to their accessibility. It’s a convenient location for most individuals.
Now, consider the contrast with the average clinical trial participant who travels 67 miles each way to the testing site, CNET’s Dan Avery reports. “Unsurprisingly, 80% of clinical trials fail to meet their enrollment target and timelines, costing drug developers millions of dollars in lost revenue and delaying the development of critical drugs, devices and other treatments.”
Let’s momentarily set aside the fact that participants endure a 90 minute commute each way for trials. At this juncture, it’s essential to recognize that such individuals, who have the time and means for lengthy commutes, represent only a fraction of the total patient population for any health condition. Enrolling larger, more diverse patient cohorts not only alleviates the participation burden but also fosters connections with patients who currently remain beyond our reach.
The Unique Position of Community Pharmacies in Clinical Trial Enrollment
“From a logistical standpoint, it would seem that the pharmacy could pose a more sensible site for getting patients enrolled in clinical trials,” Aungst writes.
Enlisting the support of pharmacies in the enrollment process would grant researchers access to a more varied patient demographic, utilizing the established trust patients have in pharmacy staff.
This goes beyond merely achieving higher clinical trial enrollment rates. As Aaron L. Schwartz, Marcella Alsan, Alanna A. Morris, and Scott D. Halpern write in The New England Journal of Medicine, boosting the diversity of all clinical trial participants helps the industry build trust among people, promotes fairness, and generates new biomedical knowledge.
Building trust and promoting fairness are of the highest importance, Schwartz et al. write. That’s because too many people are skeptical of clinical research or feel unsupported by their healthcare systems. The reasons for this are many:
- Historical abuse of vulnerable groups. Many Black Americans are familiar with the Tuskegee Syphilis Study, in which 399 Black men were unknowingly infected with syphilis, and are not quick to trust medical professionals.
- Skepticism about things such as vaccines, which flourished during the COVID-19 pandemic.
- A lack of access to a healthcare provider, whether for logistical or financial reasons.
“In many underrepresented communities, the community pharmacist is the most trusted and accessible healthcare provider,” the team at digital health company RxE2 writes. “Local pharmacists are fundamental to diversifying clinical trials because, as medication experts, they already play a central role in community healthcare. They can provide the necessary information to encourage participation and understand patient needs and the social determinants of health (SDoHs) that often prevent enrollment.”
Across the healthcare sector, there is a growing acknowledgment of the crucial role that community pharmacies play in engaging patients. Organizations like Flip the Pharmacy are even advocating for a new paradigm entirely in which community pharmacies focus on “longitudinal and patient-level care processes and business models.”
Furthermore, retail pharmacies possess a range of tools necessary to facilitate clinical trial enrollment, Moe Alsumidaie at Applied Clinical Trials writes. For example, they have informed consent tools and data-intake processes that can be made FDA-compliant, if they aren’t already. Larger retail pharmacies boast virtual and remote care technologies that hold the potential to enhance decentralized trials post-enrollment.
Integrating Community Pharmacies Into Decentralized Trials
Beyond the initial clinical trial enrollment phase, community pharmacies could become pivotal nodes in the ecosystem that supports decentralized clinical trials.
These pharmacies could “serve as clinical trials hubs, improving access and the patient experience by removing system-level barriers with convenient locations, such as the local pharmacy or at home,” writes Ramita Tandon, Chief Clinical Trials Officer at Walgreens.
“Community pharmacies can reach patients in socially vulnerable areas, fostering the ability to provide personalization and last-mile enablement at every step in the trial journey.”
This could have wide-reaching effects. Aside from easing the burden of participation for many patients and boosting retention rates, “broader geographic reach may enhance studies involving rare diseases,” attorneys Christina Markus and Geneviève Michaux write.
Challenges Faced by Pharmacy Professionals in Leveraging Clinical Trials
The vision of pharmacies serving as integral components of the clinical trial enrollment and ecosystem comes with its set of challenges.
At the operational level of enrollment, participating pharmacies would need new data-capture tools. These pharmacies could “play a role in increasing clinical trial recruitment of racial and ethnic minority patients … as the demographics of communities are often reflected in these pharmacies,” writes Alana Hippensteele, Managing Editor of Pharmacy Times.
“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.”
Nonetheless, pharmacists already engaged in their primary responsibilities face workflow challenges when integrating clinical trial processes. “Even though pharmacists are willing to participate [in clinical trial enrollment], the trial processes need to be embedded seamlessly into their workflow without causing additional burdens,” Urtė Fultinavičiūtė writes at Clinical Trials Arena.
Additionally, questions linger concerning patient privacy, suitability of pharmacies as enrollment points for specific trials, such as those focused on oncology, and the requisite training for pharmacy staff, Fultinavičiūtė notes.
Pushing the Frontiers of Clinical Trial Development
How community pharmacies fit into the future of clinical research remains to be seen. They may emerge as key touch points during recruitment. They may play a larger role in conducting the research itself.
To successfully complete the intelligence gathering and strategic decision-making that needs to happen before setting up a clinical trial, and the data capture that happens after a patient gets enrolled, researchers and sponsors can rely on the following solutions from Anju Software.
With TA Scan’s demographic and diversity data, sponsors and CROs can pinpoint specific populations to possibly enroll for their clinical trial. With TA Scan’s Trial Feasibility Wizard and Site Capacity Calculator, they can make enrollment predictions and feasibility analyses based on historical clinical trial data.
When electronic data capture is required, TrialMaster is an EDC suite that improves efficiencies and reduces workflow impact while enhancing data quality, resulting in faster study submission times.
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