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

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dc.creatorKirn, Dylan R.
dc.creatorGrill, Joshua D.
dc.creatorAisen, Paul
dc.creatorErnstrom, Karin
dc.creatorGale, Seth
dc.creatorHeidebrink, Judith
dc.creatorJicha, Gregory
dc.creatorJimenez-Maggiora, Gustavo
dc.creatorJohnson, Leigh A.
dc.creatorPeskind, Elaine
dc.creatorMcCann, Kelly
dc.creatorShaffer, Elizabeth
dc.creatorSultzer, David
dc.creatorWang, Shunran
dc.creatorSperling, Reisa
dc.creatorRaman, Rema
dc.creator.orcid0000-0001-7769-8417 (Johnson, Leigh A.)
dc.date.accessioned2023-05-24T14:42:19Z
dc.date.available2023-05-24T14:42:19Z
dc.date.issued2023-05-03
dc.description.abstractBACKGROUND: 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.
dc.description.sponsorshipThis initiative was supported by the NIH/NIA (5U24AG057437) and Eisai Inc.
dc.identifier.citationKirn, D. R., Grill, J. D., Aisen, P., Ernstrom, K., Gale, S., Heidebrink, J., Jicha, G., Jimenez-Maggiora, G., Johnson, L., Peskind, E., McCann, K., Shaffer, E., Sultzer, D., Wang, S., Sperling, R., & Raman, R. (2023). Centralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment. Alzheimer's research & therapy, 15(1), 88. https://doi.org/10.1186/s13195-023-01235-4
dc.identifier.issn1758-9193
dc.identifier.issue1
dc.identifier.urihttps://hdl.handle.net/20.500.12503/32362
dc.identifier.volume15
dc.publisherBioMed Central Ltd.
dc.relation.urihttps://doi.org/10.1186/s13195-023-01235-4
dc.rights.holder© The Author(s) 2023.
dc.rights.licenseAttribution 4.0 International (CC BY 4.0)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceAlzheimer's Research & Therapy
dc.subjectAlzheimer's disease
dc.subjectdiversity
dc.subjectrecruitment
dc.subject.meshHumans
dc.subject.meshResearch Design
dc.subject.meshData Collection
dc.subject.meshEducational Status
dc.titleCentralizing prescreening data collection to inform data-driven approaches to clinical trial recruitment
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dc.type.materialArticle

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