Introduction
A small biopharmaceutical company embarked on a Phase 2 study targeting a neurological disease related to mental health, necessitating the development of a pre-study registry to identify patients possessing a rare biomarker. Traditional recruitment methods proved inadequate, prompting the exploration of alternative strategies to augment the patient registry.
Study Background & Challenges
The study’s unique challenge lay in the rarity of the targeted biomarker within the general population, necessitating an innovative approach to identify and engage a larger cohort of potential participants. Additionally, the therapeutic area’s nature implied that potential subjects might not be inherently motivated to respond to conventional recruitment advertisements.
Solution Methodology
Implementation Framework
The recruitment strategy centered on leveraging the trust inherent in patient-pharmacist relationships. Fifteen clinical sites were identified where local pharmacy support could enhance recruitment efforts. Pharmacies within a 35-mile radius of these sites were selected based on their patient demographics, aligning with the study’s specific racial and ethnic requirements.
RxE2 employed its proprietary patient-matching algorithm to sift through pharmacy data, identifying potential participants based on the study’s inclusion and exclusion criteria. This technology-enabled approach facilitated the targeted engagement of suitable candidates by participating pharmacists.
Operational Execution
- Forty-six community pharmacies were enlisted and underwent training to execute the study recruitment process effectively.
- Pharmacists initiated contact with 2,245 patients, averaging 49 contacts per pharmacy.
- The engagement process involved conducting interviews to assess interest and eligibility, followed by referrals to the study registry for eligible patients.
Benefits of the RxE2 Solution
Faced with the challenge of how to engage community pharmacies, RxE2 emerged as the pivotal solution for the study sponsor. By streamlining access to a ready-to-mobilize community pharmacy network, RxE2 effectively became the sponsor’s “Easy Button” for initiating a novel recruitment channel.
- RxE2 facilitated 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 data insights, significantly reducing the complexity of engagement, data analysis, 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
Of the patients contacted, 48% expressed willingness to undergo the interview process.
Approximately 46% of those interviewed were deemed eligible and referred to the registry.
The registry saw 261 successful registrations, with a subsequent screening identifying 207 qualified participants.
Pharmacist Engagement
Post-project feedback from participating pharmacists revealed a high receptivity among patients to clinical trial discussions, with 69% of pharmacists observing positive patient responses.
Conclusion – Lessons Learned and Looking Ahead
The project underscored the efficacy of utilizing community pharmacies as a conduit for patient recruitment, particularly for studies targeting specific biomarkers or patient demographics. The trust between patients and pharmacists emerged as a pivotal factor in enhancing patient engagement and willingness to participate in clinical studies.
This case study illustrates the potential of community pharmacies to significantly contribute to patient recruitment for clinical trials, especially in scenarios where traditional methods falter. The patient-pharmacist trust factor, combined with advanced data analytics, presents a promising avenue for bolstering pre-study registries and ultimately enriching the participant pool for clinical research.
RxE2 continues refining proprietary data analytics and algorithms while supporting community pharmacists with tools, training and support to amplify recruitment efficiency.

