Community Pharmacists Can Help Sponsors Meet Trial Diversity Requirements
By Deborah Borfitz
March 14, 2023 | Independent, community-based pharmacists are in an ideal position to improve the equitable representation of racial and ethnic groups in clinical research, as required under the recently enacted 2023 omnibus spending bill, according to Gerald Finken, CEO of RxE2. How to accomplish this is spelled out in a white paper, termed the Diversity Now protocol, newly published by the company that focuses on improving the recruitment and retention of underrepresented populations.
More than 3,500 of the nation’s independent retail pharmacies are now on RxE2’s platform, powered by cutting-edge technology, which searches pharmacy demographics and data to identify strategic locations and potential participants to contact about clinical trials, he says. “We know we have [the diversity problem] solved,” says Finken, referencing the enabling work of Chief Pharmacy Officer Tina Schlecht.
As Finken sees it, community pharmacists will inevitably be serving as principal investigators (PIs) on studies. Ensuring a diversity of participants in trials is the initial proving ground—and a timely response to relevant draft guidance on the matter issued last year by the Food and Drug Administration (FDA).
The Diversity Now protocol specifically addresses language in FDA guidance about having a specific plan of action to enroll and retain diverse participants and the status of meeting enrollment goals. It could be paraphrased and inserted into a clinical trial protocol by drug and device companies to meet regulatory expectations and legal requirements, Finken says.
Retail pharmacies are in a great position to deliver on regulatory-grade diversity plans because of their “breadth of access” to populations relative to individual medical clinics, he continues. But RxE2 is uniquely able to look at real-world prescription data to identify desired patient groups.
“Just because you’re in the community doesn’t mean underrepresented populations are coming through the door,” stresses Finken. RxE2 has done the work of confirming the foot traffic matches publicly available census and demographic data on those neighborhoods.
RxE2 connects independent pharmacies with clinical sites and studies on behalf of sponsor companies, in addition to helping pharmacists identify patients for trials and keeping them engaged, adherent, and compliant using machine learning algorithms and predictive tools, he explains. Importantly, from the diversity perspective, a trusting relationship with their customer base is a business imperative and they therefore know who is on a fixed income, has memory issues, or relies on public transportation.
Ensuring pharmacy management systems have the necessary fields to document social determinants of health (SDOH) remains a “work in progress,” says Schlecht, “but pharmacies are now working to become the center points for collecting this information... in a database where it can be aggregated and analyzed more closely.”
FDA draft guidance instructs study sponsors to describe their specific trial enrollment and retention strategies and independent community pharmacies routinely advocate for patients to ensure their needs are met—be that direct home delivery of prescription drugs, providing fittings and other assistance with needed medical devices, or serving as community health workers by connecting patients with community resources for getting to medical appointments and finding childcare coverage and coupons to pay for medications, Schlecht says.
Sponsors ideally involve pharmacists early in a clinical trial, meaning either during the protocol development process or study planning stage, says Schlecht. Pharmacists would create a patient questionnaire, for approval by the sponsor and institutional review board, which they would use in interviews with patients to ensure all the required data—including SDOH information—is collected and patients best fitted for the study are identified. Study participants, as a matter of course, would get adherence counseling and have any questions immediately answered.
Pharmacists play a critical role as healthcare providers in the community, especially for underserved populations, because of their access to prescription history data—including when medications started and stopped as well as dosing and compliance and, to some degree, the associated diagnosis codes, Schlecht says. They tend to see customers on a quarterly if not monthly basis, which is much more frequently than they see their prescribing physician or any other healthcare provider.
While the FDA oversees the conduct of PIs in clinical trials, the practice of medicine pertaining to physicians and the dispensing of medications relevant to pharmacists are governed by separate sets of state laws, points out Finken, as was learned the hard way with decentralized clinical trials during the pandemic. So, it makes sense for pharmacists around the country to dispense an investigational drug and use their trusted relationship with people in the community to refer patients to current study PIs with whom they have a collaborative practice agreement.
Critically, pharmacists can provide patient feedback to PIs about issues related to the use of the medication, adds Schlecht. That might be something as egregious as thinking they are supposed to take a drug once rather than twice a day or letting a product that needs refrigeration sit on the counter or in their car. Less seriously, participants might not know what to do if they miss a dose or need help thinking through how to travel with the investigational drug. Pharmacists might also be the first to hear about difficulties in getting to study visits, which could impact the retention of participants if not appropriately addressed.
Sustained community engagement, also referenced in FDA guidance, is built into the DNA of local pharmacies, Schlecht continues. The workflows and communication skills required for recruiting and referring trial participants were on full display when pharmacies set themselves up as COVID testing centers and vaccination sites—and managed to do all the scheduling and documentation work outside a pharmacy management system. Many independent stores additionally have experience with prior authorization processes and clinical services such as diabetes education, smoking cessation programs, and blood pressure screenings.
They have understood for decades the importance of front-of-the-counter services, interjects Finken, adding medication therapy management to the list. As with clinical trials, specific protocols must be followed to enroll participants and many times pharmacists are working directly with a primary care provider.
He cites as examples the growing number of pharmacists who will assess the need for over-the-counter hearing aids and assist in product selection, and their collaboration with local audiologists for people who can’t be helped by these devices. It’s part of the mindset epitomized by the Flip the Pharmacy initiative to shift community pharmacies away from point-in-time, prescription-level care processes to longitudinal, patient-level care services and business models. “Every one of these programs requires recruitment,” notes Finken.
RxE2 currently has just under 20% of the nation’s 19,600 independent community stores in its network, and admittedly has work to do in getting diversity information on their patient populations properly recorded. But its technology platform nonetheless has a demonstrated ability to turn pharmacies “off and on” to meet needed trial enrollment goals in a matter of weeks, Finken says.
Independent pharmacies, unlike other providers in the community—including, potentially, chain pharmacies—have the trust and SDOH boxes are “already checked,” he adds. They not only have a database but a long-term relationship with customers that took years to establish.
“We are gaining great traction and interest in phase 2 and phase 3 studies,” reports Schlecht. The draw is RxE2’s ability to retain as well as recruit patients into studies.
This is related to the most-impactful counseling role of independent pharmacists, Finken says, noting that FDA diversity guidance speaks to the importance of “not just delivering the patient to the clinical trial but keeping them in [it].” Similarly, they “can eliminate a lot of the noise in post-marketing studies” because patients regularly return to their local store where a pharmacist can help distinguish the effects of an investigational product from their other prescribed medications.
Schlecht joined RxE2 as chief pharmacy officer only two years ago, but she and Finken first worked together back in 2000 when he was leading a company called Clinical Supplies Management offering “pharmaceutical care” to patients regarding how to use and store their medications. They quickly saw the parallel need in clinical research, which led to the company’s involvement in more than a dozen phase 2 and 3 studies where pharmacists were educating patients on the use of an investigational product at home.
Employed pharmacists were asking trial participants open-ended questions about what they learned at a study site. “We found that over 90% of the patients had some sort of issue with the use of the medication when they got home,” Schlecht says. Understandably, patients didn’t remember instructions on how to use a drug since the information was often shared at the end of a lengthy visit for which they had been fasting for 12 hours.
Participants not taking a drug correctly may drop out of a study because they’re not getting the desired effects. But they also may need assistance if they are feeling confused or have questions they don’t feel comfortable taking back to the study site, says Schlecht. The clinical trials research pharmacist program then be offered by Clinical Supplies Management had pharmacists on call 24/7 to offer any needed support.
Learnings from that program have been ported over to RxE2, says Schlecht. Her role as chief pharmacy officer is reportedly a first for the pharmaceutical industry.