Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment

Abstract

Background Recruiting to multi-site trials is challenging, particularly when striving to ensure the randomized sample is demographically representative of the larger disease-suffering population. While previous studies have reported disparities by race and ethnicity in enrollment and randomization, they have not typically investigated whether disparities exist in the recruitment process prior to consent. To identify participants most likely to be eligible for a trial, study sites frequently include a prescreening process, generally conducted by telephone, to conserve resources. Collection and analysis of such prescreening data across sites could provide valuable information to improve understanding of recruitment intervention effectiveness, including whether traditionally underrepresented participants are lost prior to screening. Methods We developed an infrastructure within the National Institute on Aging (NIA) Alzheimer’s Clinical Trials Consortium (ACTC) to centrally collect a subset of prescreening variables. Prior to study-wide implementation in the AHEAD 3–45 study (NCT NCT04468659), an ongoing ACTC trial recruiting older cognitively unimpaired participants, we completed a vanguard phase with seven study sites. Variables collected included age, self-reported sex, self-reported race, self-reported ethnicity, self-reported education, self-reported occupation, zip code, recruitment source, prescreening eligibility status, reason for prescreen ineligibility, and the AHEAD 3–45 participant ID for those who continued to an in-person screening visit after study enrollment. Results Each of the sites was able to submit prescreening data. Vanguard sites provided prescreening data on a total of 1029 participants. The total number of prescreened participants varied widely among sites (range 3–611), with the differences driven mainly by the time to receive site approval for the main study. Key learnings instructed design/informatic/procedural changes prior to study-wide launch. Conclusion Centralized capture of prescreening data in multi-site clinical trials is feasible. Identifying and quantifying the impact of central and site recruitment activities, prior to participants signing consent, has the potential to identify and address selection bias, instruct resource use, contribute to effective trial design, and accelerate trial enrollment timelines.

The usage of population and disease registries as pre-screening tools for clinical trials, a systematic review

“…Research teams usually have team specific pre-screening processes, as there are no national consensus, guidelines nor universal standard operating procedures (SOPs) on how to conduct the pre-screening for clinical trials. A typical pre-screening process may include an internal check of the hospital medical journals in paper format, a review of electronic medical journals, a review of medical journals sent via traditional mail in case of a referral, direct emails from patients emailing a research team, and more [ 27 – 30 ]. This creates a pool of information derived from several sources, with no standardized system assuring quality and replicability, not allowing an audit trail for quality assurance and control, and overall creating inequitable trial access for patients [ 31 ].…”