Abstract C067: <i>Screen failures in early-phase oncology trials: A single-center UK analysis of decentralized recruitment methods</i>
Abstract Background: Screen failures (SFs) in early-phase oncology trials (EPOTs) compromise trial efficiency, resource allocation, and patient experience. During the COVID-19 pandemic, our center adopted decentralized strategies—including telehealth consultations and remote investigations—to maintain recruitment. This shift has enabled broader access for patients beyond our immediate catchment area. We aimed to review our recent SF patterns, assess the impact of remote processes on SF rates, and identify modifiable factors to optimize future decentralized recruitment. Methods: We retrospectively reviewed electronic medical records to identify patients consented to EPOTs at a specialist UK center between January 2023 and December 2024. Data collected included patient demographics, consultation type (in-person or remote), EPOT type, and specific reasons for screen failure. Statistical comparisons were performed in RStudio using Fisher’s exact test, chi-squared test, and Mann–Whitney U test. Results: Among 202 patient consents (median age 62 years [IQR 54–68], 55.4% male, median performance status 1, median clinical frailty score 2), 38% of pre-screen visits were conducted by telephone. Overall median residential distance from the hospital was 48 km, with patients assessed remotely living farther away than those seen in person (median 78 km vs. 35 km; p &lt; 0.001). The median interval from first contact to consent was 94 days. SF occurred in 21% (42/202) of patients, at a median of 12 days post-consent. SF rates were unaffected by consultation type, travel distance, or deprivation index. By investigational medicinal product (IMP) class, SF was highest for immunotherapy EPOTs (33%) and lowest for chemotherapy EPOTs (10%) (p = 0.03). Central nervous system (CNS) (50%), hepatobiliary (40%), and urological cancers (28%) had the highest SF rate, whereas lung (14%), upper gastrointestinal (14%), and colorectal cancers (12%) had the lowest. Leading SF causes were patient-related at 27% (comorbidities and increasing symptom burden), laboratory-related at 23% (deranged liver function tests and anemia), and imaging-related at 21% (rapidly progressive disease and new CNS metastases). Retrospective adjudication found that 11.9% of SF events were potentially preventable where the cause predated but was not identified before consent. Despite this, absence of recent (&lt;28 days) pre-consent blood tests or physical examination did not increase SF rates (p = 0.64 and 0.18 respectively). Evaluation of strategies to reduce SF is ongoing. Conclusion: Decentralized recruitment methods, including remote consultations, are a feasible and effective approach for EPOTs, with no observed increase in SF rates. These findings support expanding hybrid and remote recruitment models to improve trial accessibility without compromising screening efficiency. Targeted operational refinements—such as timely pre-consent assessments and IMP-specific triage—can further reduce preventable SFs. Citation Format: Francis P. Young, Gemma Wickert, Heather Parry, Matthew Krebs, Louise Carter, Fiona Thistlethwaite, Donna Graham, Natalie Cook. Screen failures in early-phase oncology trials: A single-center UK analysis of decentralized recruitment methods [abstract]. In: Proceedings of the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2025 Oct 22-26; Boston, MA. Philadelphia (PA): AACR; Mol Cancer Ther 2025;24(10 Suppl):Abstract nr C067.
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