Introduction & Study Background
The rapid enrollment of participants is a cornerstone of clinical trial success. A large biopharmaceutical company, faced with the imminent start of an observational vaccine study, sought innovative strategies to enhance patient recruitment efficiency. The company aimed to recruit and register a significant number of novel patients to the trial’s registry within a constrained timeframe of 6 8 weeks. The sponsor sought to leverage the recent success observed in community pharmacy led vaccine distributions during the COVID 19 pandemic to enhance recruitment and registration processes for their trial. With the tight timeline, the company turned to RxE2 who offered a solution opening the community pharmacy pathway.
Facing the imperative to rapidly enroll participants, the sponsor a well established figure in the biopharmaceutical industry aimed to augment traditional recruitment channels with innovative approaches capable of attracting and registering a substantial number of new participants to their trial’s digital platform. The primary objective was to leverage the accessibility and community trust of pharmacies to facilitate the recruitment and web based registration of participants unfamiliar with traditional clinical trial avenues.
Solution, Deployment and Timeline
The approach centered on RxE2’s established community pharmacy driven recruitment
framework, encompassing:
- Selection and engagement of pharmacies with a strong community presence
- The technology platform and comprehensive training of pharmacy personnel to ensure adherence to recruitment protocols
- A tech enabled workflow that entailed proactive patient outreach by pharmacy staff, leveraging existing patient relationships, followed by telephonic or face to face interviews to assess interest and eligibility, culminating in assistance with online registration for qualifying candidates
- The strategic deployment of pharmacies in successive waves to incorporate adaptive measures based on ongoing evaluations
The rapid deployment saw pharmacies across 12 states being prepared and operational within six weeks, aligning with the study’s initiation timeline, with a concentrated recruitment effort spanning 20 days.
Pharmacies were introduced to the recruitment effort in successive waves, allowing for iterative refinement of strategies based on early experiences and feedback. This phased approach facilitated adaptability and continuous improvement in recruitment tactics.
Benefits of the RxE2 Solution
RxE2 emerged as the pivotal solution for the study sponsor, who faced challenges
navigating the complexities of engagement of nearly 20,000 independent community
pharmacies in the United States . RxE2 streamlined access to a ready to mobilize
community pharmacy network, effectively becoming the sponsor’s “Easy Button” for
initiating a novel recruitment channel.
- RxE2 expedited access to an extensive network of community pharmacies, complete with pre-established agreements and rigorous patient data protections, ensuring a smooth operational framework.
- The RxE2 technology platform equipped pharmacies with user friendly onboarding, comprehensive training, and advanced AI tools, significantly reducing the complexity of engaging pharmacies, analyzing data, and identifying potential participants.
- The proficiency of RxE2 Pharmacy Operations ensured tailored support for the sponsor’s needs while bolstering community pharmacies with the necessary guidance and resources.
Results and Challenges Overcome
- Engagement with 84 pharmacies across 12 states led to a potential participant pool of 40,000 individuals.
- Over a 20 day period, pharmacists attempted to contact 9,019 patients, successfully engaging 5,328 (a 60% contact rate).
- A total of 1,626 interviews were conducted, identifying 783 eligible participants, with 255 completing the registration process, and meeting all requisite.
- Of the 255 registrants, 67 patients consented to join the study.
Conclusion – Lessons Learned and Looking Ahead
The initiative underscored the viability of community pharmacies as an effective conduit for clinical trial recruitment, particularly in scenarios requiring rapid participant enrollment. Key learnings included:
- The importance of early engagement with recruitment partners like RxE2 to streamline the onboarding and activation of pharmacies.
- he value of a flexible, wave based deployment strategy to incorporate real time adjustments and optimize recruitment outcomes.
This case study demonstrates the viability and effectiveness of utilizing community pharmacies to augment participant recruitment in clinical studies, particularly under tight timelines. The collaborative approach, combining the expertise of RxE2 with the community centric model of pharmacies, presents a replicable process and promising adjunct to traditional recruitment strategies, warranting further exploration and refinement in future clinical research endeavors.
