Overview
Acumen Pharmaceuticals tried to create an ongoing newsletter for Phase 2 participants in response to previous participants’ requests for more science communication. The initiative encountered IRB review requirements for every issue, EU/US regulatory differences in what could be shared, outdated content between drafts, and translation burden. While it never launched, the experience could inform future participant communication efforts.
Methods
- Developed a participant and caregiver newsletter concept in response to feedback from Phase 1 exit interviews, which indicated a desire for more information about Alzheimer’s disease, study progress, and the investigational treatment
- Created a newsletter template containing educational content, study updates, caregiver-focused information, reminders, and community-building features.
- Designed content to support participant retention and strengthen participant and study partner engagement throughout a global Phase 2 trial.
- Planned deployment across multiple countries and languages, requiring regulatory review, translation, and localization for diverse participant populations.
- Evaluated implementation requirements across central IRBs, local ethics committees, and country-specific regulations before launch.
Metrics
- Planned for use across a global Phase 2 study with 76 sites in 5 countries
- Developed a complete newsletter template and multiple draft study update sections prior to implementation.
- Required translation and localization across multiple study languages and regions.
- Would have required ongoing IRB/ethics submissions and approval for each newsletter edition.
- Newsletter initiative was ultimately not launched due to regulatory, operational, timing, and cost barriers.
Key Lessons
- Participant feedback consistently showed a desire for more communication and study updates throughout trial participation.
- Global participant communications are significantly more complex than they initially appear due to varying IRB, ethics committee, and country-specific requirements.
- Translation, regulatory review, and approval timelines can make timely study updates difficult to deliver.
- Recurring communication tools may become cost-prohibitive when each issue requires separate review and approval in addition to translations.
- The clinical research industry would benefit from standardized participant communication frameworks and pre-approved retention communication guidance.
Contact
Robyn Moxon — [email protected]
*Content last updated September 2026
