Centralized Participant Recruitment Efforts / Sponsor-led Recruitment Support
Alzheimer’s, fits
EVENTS, RECRUITMENT
The Generation Program was a collaborative effort between Novartis, Amgen, and Banner Alzheimer’s Institute. A dedicated team including multiple representatives from each organization was formed and charged with managing the outreach and recruitment efforts. This team included clinical scientists, clinical trialists with considerable expertise being site investigators, researchers with expertise in registries and participant recruitment, project managers, clinical operations specialists, and site relationship and protocol medical/execution support managers. Since there was not a “one size fits all” recruitment plan for deploying these materials that would work for all countries or study sites, representative form the sponsor team focused on building relationships with individual sites to understand their site-specific needs. This involved one-on-one calls and, in some cases, in-person visits to the sites soon after site activation to help develop and implement customized recruitment plans specific to each site’s needs and capabilities. In many cases, these individualized interactions continued throughout the recruitment period, allowing the sponsor team and site personnel to further refine outreach and recruitment activities and provide additional targeted support to sites to meet their recruitment and enrollment goals. Examples of activities and tactics included development or implementation of site-specific recruitment ads, genetic testing “swabbing” events at which consent was obtained to collect genetic samples from a large number of individuals at one time (The sponsor team provided opportunities for site personnel to share their outreach and screening experiences identifying and enrolling APOE ε4 carriers (often with an emphasis on APOE ε4 HMs, given the low [2-3%] prevalence of the genotype), spurring new ideas and forming collaborations among sites. In the US, the sponsor team held six regional roundtable dinner meetings during which representatives from 10-12 nearby sites discussed recruitment activities. Attendees included site principal investigators, study coordinators, recruitment / outreach specialists as well as representatives from the sponsor team. The sponsor team also held two larger, one-day recruitment and retention focused workshops in the US and three in Europe. Representatives from all sites in these regions were invited to these workshops along with members of the sponsor team. Principal investigators (PIs) from sites with high screening and enrollment numbers were invited to speak at the roundtables and workshops to share their strategies and tactics with other sites. The regional roundtable meetings and one-day workshops also provided a venue to discuss protocol and scientific questions with the sponsor team.The sponsor team held regular country-specific teleconferences with site personnel from that region to discuss outreach, recruitment, screening, and retention, answer frequently asked questions about participant prescreening and the protocol, clarify study memos, and any other questions from site teams in real time. These were complemented by monthly “media and communications support” teleconferences led by the PR firm or sponsor team that provided tips for sites to engage with their local media and strategies for using social media for recruitment. All sites received weekly newsletters with study updates, enrollment metrics, and other pertinent, time-sensitive information.