As several retail pharmacy chains proclaim a rosy outlook for ongoing efforts to expand their services into the clinical trials arena in the wake of the pandemic, traditional study site personnel and patients interviewed on the topic offered more mixed and nuanced concerns about the prospects for near-term success for such ventures.
“With retail pharmacies entering the clinical trial space, investigative sites are left with little information around how this move will affect them or their patients,” says Emily Botto, Senior Research Analyst at the Tufts Center for the Study of Drug Development (CSDD) and a scheduled presenter at the ACRP 2024 conference in Anaheim, Calif. “Retail pharmacies have stated their ability to make clinical trial recruitment and retention more efficient and to increase participant diversity, but no publicly available data exists to support these claims outside the COVID-19 pandemic.”
It is important to understand the perspectives of site staff and potential trial patients to assess the receptivity of the market to retail pharmacy proposals and the perceived viability of these models, notes Botto, who is also a coauthor of a peer-reviewed article on the matter forthcoming in ACRP’s Clinical Researcher journal alongside Tufts CSDD colleagues Hana Do, MPH, Ruby Madison Ford, MPH, and Kenneth Getz, MBA. The team conducted interviews among site personnel and patients in the summer of 2023 to investigate their experience with, awareness of, and receptivity to retail pharmacies being active in clinical trials.
The perspectives of site personnel have been largely absent from existing commentary on pharmacy involvement in clinical trials, Botto says. “Not only are site personnel experts on the services that retail pharmacies are proposing to offer, but they are also the primary stakeholders interacting with clinical trial participants,” she adds. “In order to partner with sites to recruit patients and provide decentralized clinical trial elements, retail pharmacies need to build trusted relationships with sites.”
The Tufts CSDD team interviewed 10 patients in collaboration with the Center for Information and Study on Clinical Research Participation and 11 investigative site personnel, including principal investigators, clinical research coordinators, and administrative personnel. Trust in pharmacy retailers and their involvement in clinical trials were addressed among both groups.
Site personnel expressed distrust in retail pharmacy site staff producing quality work in the absence of senior staff overseeing trial-related activities, Botto observed. The principal investigators in this study voiced their concerns about losing a direct connection with study participants and not personally overseeing care provided to them.
Site personnel participants also voiced their concern about whether pharmacies would be prepared to handle secure transfer of data between the pharmacy and the site; about accountability around regulations and who will be liable for any safety issues, mistakes, or deviations within the pharmacy-led models; and about how well pharmacies will be prepared for U.S. Food and Drug Administration guidelines and audits.
Patient participants expressed concerns about credentials and training related to trial activities, perceiving the pharmacy’s role as limited to filling medication prescriptions and occasionally administering vaccines, Botto notes. Some patient participants were more open to the idea of participating in models where they would receive trial procedures at a pharmacy, but only if their routine doctor recommended the clinical trial or was overseeing the study.
Both site personnel and patients believed that using pharmacies would increase convenience. Site personnel suggested that retail pharmacy involvement could also distribute the workload among staff at traditional sites, with participants having the option to go to a traditional clinic or pharmacy for lab work. Another identified benefit of retail pharmacy alternative models is the potential increase in participant diversity.
Join Emily at ACRP 2024 [May 3 – 6; Anaheim, CA], where she will explore attitudes of site personnel, biopharmaceutical executives, and patients concerning the barriers and opportunities to pharmacy involvement on this new horizon for decentralized clinical research. View complete schedule.
At any rate, “The recent exit of CVS Health after only two years of operating its clinical trial services unit raised further questions around the viability of these approaches, including patient interest and drug development industry receptivity to proposed models,” Botto says. “Retail pharmacies have made broad statements about how their proximity to patients and access to large patient databases could improve diversity, equity, and inclusion in clinical trials. These statements suggest that patients from diverse backgrounds are both interested in and open to the idea of enrolling and participating in clinical studies through retail pharmacy services.”
However, Botto adds, there is no publicly available research among patients to support these statements. Gathering more perspectives of patients from diverse disease indications and demographic backgrounds, such as personal experience and opinions of retail pharmacy organizations in the context of clinical trials, is essential to understand the probability of success of these strategies outside the situational aspects of the COVID-19 pandemic, she says.
Edited by Gary Cramer