Innovation or Replication? Learning From the Prior Experiences of Trial Recruitment
Abstract
Introduction: Optimal clinical trial recruitment strategies are not completely known. Recruitment is difficult and costly and many trials fail to meet their recruitment goals despite multiple strategies.
Methods: A literature review helped determine prior barriers to trial recruitment and prior successful recruitment strategies. We analyzed retrospective data from our site's trial recruitment log for the GRAIL Pathfinder 2 trial (a nationwide, prospective and interventional multi-cancer detection trial). Our site's recruitment data was then classified as 1) replication of prior successful strategies (face-to-face office visit, presentations at community events, paper flyers with the study's information, and word of mouth), 2) replication of prior unsuccessful strategies (radio ad and study hotline) or 3) innovative method (prior study research participant). An interview was conducted with our institution's GRAIL study Research Associate to gain qualitative insight on the trial's recruitment processes. Descriptive statistics were utilized for the data extracted from the recruitment log. Qualitative coding was completed for an exploratory analysis using descriptive coding for the interview data.
Results: Our site recruited 47 patients between September 1st, 2023 and February 1st, 2024. The most successful recruitment strategy was face-to-face office visits (16 patients). Other successful strategies included a radio ad (8 patients) and paper flyers with the study's information (8 patients). Unsuccessful and less successful strategies included a Facebook post (0 patients) and a study hotline (1 patient). Replication of prior successful methods resulted in 31 patients (66%) being recruited. Replication of prior unsuccessful methods resulted in 9 patients (19%) being recruited. Finally, using innovation, we recruited 7 patients (15%) who had participated in previous study site trials. The qualitative interview with our Research Associate demonstrated that the greatest barrier to recruitment was the inability to enroll volunteers who are not registered through our medical group.
Conclusion: This study demonstrates that trial recruitment should focus on strategies that have been previously successful. An exciting new recruitment strategy which needs to be explored further is enrolling patients from previous trials. Our single site study is limited due to a small sample size from the first five months of recruitment.