Overview
Acumen Pharmaceuticals entered Phase 1 with a central recruitment model effective at that scale. For Phase 2 with 76 sites, it leaned on individual sites to design geography- and population-specific strategies rather than deploying a one-size-fits-all campaign. Case study demonstrates why Phase 2/3 recruitment requires a fundamentally different approach from Phase 1.
Methods
- Transitioned from a centralized recruitment model used in Phase 1 to a site-led recruitment strategy for a Phase 2 global study spanning 76 sites across 5 countries
- Asked U.S. sites to complete a Site-Specific Recruitment and Retention Plan (SSRRP) outlining anticipated recruitment sources and diversity strategies
- Provided sites with recruitment funding opportunities through proposal submissions rather than directing specific tactics.
- Developed centrally approved and translated recruitment materials, including brochures, posters, social media content, patient letters, physician referral letters, and press release templates.
- Allowed sites to implement recruitment approaches that best fit their local geography, culture, language, patient population, and community relationships.
- Focused sponsor support on enabling sites rather than deploying a one-size-fits-all global recruitment campaign.
Metrics
- 76 sites across 5 countries participated in ALTITUDE-AD.
- 2,362 participant screenings resulted in 542 randomized participants.
- Enrollment was completed in approximately 13 months, from first patient screened to last participant randomized.
- Site databases generated 52% of screened participants and 62% of randomized participants, making them the most effective recruitment source.
- Recruitment source projections submitted by sites closely matched actual participant recruitment patterns, demonstrating strong local understanding of recruitment opportunities.
Key Lessons
- Recruitment strategies that succeed in Phase 1 may not be scalable across large global studies.
- Local sites often understand their communities, referral networks, and patient populations better than a central sponsor team.
- Providing sites with funding, tools, and flexibility can be more effective than prescribing recruitment tactics.
- Site databases and physician referrals consistently outperformed broader outreach approaches because of existing trust and prequalification.
- Implementing local and site-led recruitment and awareness activities supports sites in building their site databases, which historically are strong funnels for patients to learn about and enroll in clinical trials.
Contact
Robyn Moxon — [email protected]
*Content last updated September 2026