Patient Recruitment
Screen Failure
A screen failure is a clinical trial candidate who consents and undergoes screening but does not meet all inclusion criteria or meets one or more exclusion criteria, and is therefore not enrolled or randomized.
Screen failure rates of 30; 50% are common across therapeutic areas and approach 70% in oncology and rare-disease trials. Each screen failure consumes site coordinator time, lab work, and imaging resources without producing an enrolled patient.
Reducing screen failure rates is the primary value driver of AI-based EHR pre-screening: by quoting the failing criterion against the patient's chart in advance, only likely-eligible candidates are scheduled for screening visits.
Related terms
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.
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.
Screening Visit
A screening visit is the in-clinic assessment at which a potential clinical trial participant is formally evaluated against the protocol's inclusion and exclusion criteria, typically through medical history, physical examination, lab work, and protocol-specific tests.
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.
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