Real-time evaluation and adaptation to facilitate rapid recruitment in a large cohort

Abstract

Objectives Recruiting large, diverse cohorts efficiently can speed the translation of findings into care across a range of scientific disciplines and medical specialties. Yet, efficient recruitment can be hampered by factors such as financial barriers, logistical concerns, and lack of resources for patients and clinicians. Here we use a case study of a large, prospective trial of a multicancer early detection test to describe how the study team tracked enrollment, protocol fidelity, and participant experience and iteratively adapted procedures. Methods While conducting a large, prospective trial of a multicancer early detection blood test at Geisinger, an integrated health system in central Pennsylvania, we monitored recruitment progress, fidelity to protocol procedures, and participants satisfaction. Tracking mechanisms such as paper records, electronic health records, research databases, dashboards, and electronic files were utilized to measure each outcome. We then reviewed study procedures and timelines to list the implementation strategies that were used to address barriers to recruitment, protocol fidelity and participant satisfaction. Results We enrolled 10,006 women ages 65 to 75 over 22 months. Adaptations to recruitment and enrollment methods that contributed to achieving the enrollment goal included adopting group consenting, improving visit convenience, increasing electronic capture and tracking of data and source documents, staffing optimization via leveraging resources external to the study team when appropriate, and integrating the disclosure of study results into routine clinical care without adding unfunded work for physicians. We maintained high protocol fidelity and positive participant experience as exhibited by a very low protocol deviation rate and a low number of participant complaints. Conclusion Recruiting rapidly for large studies, and thereby facilitating clinical translation, requires a nimble, creative approach that marshals available resources and changes course according to data. Planning a rigorous assessment of a studys implementation outcomes prior to study recruitment can further ground study adaptations and facilitate translation into practice. This can be accomplished by proactively and continuously assessing and revising implementation strategies.

Integrating primary care, shared decision making, and community engagement to facilitate equitable access to multi-cancer early detection clinical trials

“…As demonstrated in the DETECT-A study ( 42 ), the Multi-Cancer Screening Research Program successfully enrolled 10,000 females in less than two years. The team’s approach included distributing study teams of research assistants and phlebotomists to 22 clinical and community sites across Geisinger’s geographic service area ( 43 ).…”