Clinical Trial Patient Recruitment: The Pre-Screening Call Nobody Staffs

Clinical trial recruitment often fails not because referrals are unavailable, but because understaffed sites cannot promptly complete pre-screening calls that confirm interest, collect basic protocol-relevant information, assess logistical feasibility, and schedule screening visits. Coordinators’ clinical responsibilities, uneven referral volumes, limited calling hours, and inconsistent retry efforts allow potential participants to lose interest, while insufficient pre-screening can send unsuitable candidates into costly clinical visits. Automated voice systems may help by contacting referrals quickly, handling structured nonclinical questions, scheduling appointments, and routing callers to staff, but they must not obtain informed consent, determine eligibility, provide medical advice, or pressure individuals to participate. Deployment requires appropriate authority to contact people using protected health information, such as authorization or an IRB or Privacy Board waiver, as well as HIPAA safeguards, vendor agreements, data-minimization practices, IRB approval for scripts, and compliance with calling and recording laws. The recommended approach is to use an IRB-approved script, keep clinical and consent decisions with qualified staff, test transfers carefully, begin with a single-site pilot, and measure performance through time to first contact, contact and completion rates, booked and attended screenings, screen failures, and cost per randomized participant.

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