Patient Recruitment
Screen Failure Rate
The screen failure rate is the percentage of patients who consent to be screened for a clinical trial but are subsequently found ineligible and not randomized.
Screen failure rate (SFR) is calculated as: (patients screened ; patients randomized) / patients screened. The industry median SFR is 30; 40% across therapeutic areas and exceeds 60% in oncology, where biomarker-driven trials require multiple sequential confirmations.
Each screen failure has a hard dollar cost: site fees for the visit, lab and imaging charges, coordinator time, and; critically; the participant's lost trust in research. Reducing SFR is therefore one of the highest-ROI levers in trial operations.
AI pre-screening reduces SFR by applying eligibility criteria to existing chart data before any visit is scheduled, so only patients with documented evidence of meeting the criteria are invited to screen. Sponsors using Kitsa KScreener report up to 68% reductions in screen failure rate.
Related terms
Patient Pre-screening
Patient pre-screening is the process of evaluating individuals against a clinical trial's inclusion and exclusion criteria, before formal screening visits, to identify likely-eligible candidates and reduce screen failure rates.
Inclusion / Exclusion Criteria
Inclusion and exclusion criteria are the protocol-defined conditions a person must satisfy (inclusion) or not exhibit (exclusion) to be eligible to enroll in a clinical trial.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
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