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

Area of Science:

• Clinical Trials
• Health Services Research
• Gerontology

Background:

• Recruiting demographically representative samples for multi-site trials is challenging.
• Disparities in race and ethnicity enrollment and randomization are documented.
• Pre-consent recruitment disparities, particularly during prescreening, are under-investigated.

Purpose of the Study:

• To develop and assess an infrastructure for centrally collecting prescreening data in multi-site clinical trials.
• To identify potential participant loss prior to screening and address selection bias.
• To inform recruitment strategies and improve trial design and enrollment timelines.

Main Methods:

• Developed a centralized data collection infrastructure within the National Institute on Aging (NIA) Alzheimer's Clinical Trials Consortium (ACTC).
• Collected prescreening variables (age, sex, race, ethnicity, education, occupation, zip code, recruitment source, eligibility status, ineligibility reason) during a vanguard phase of the AHEAD 3-45 study.
• Collected data from seven study sites prior to full study-wide implementation.

Main Results:

• Centralized capture of prescreening data was feasible across all participating vanguard sites.
• Prescreening data was collected on 1029 participants, with significant variation in numbers per site.
• Learnings from the vanguard phase informed design, informatics, and procedural changes for study-wide launch.

Conclusions:

• Centralized capture of prescreening data in multi-site clinical trials is feasible and valuable.
• This data can identify and quantify the impact of recruitment activities before consent.
• Potential benefits include addressing selection bias, optimizing resource use, improving trial design, and accelerating enrollment.