Addressing screening failures in early-phase clinical trials in oncology: impact on patient outcomes and strategies for improvement.

ABSTRACT:

Background

Early-phase trials (EPT) assess efficacy/safety of new drugs that may represent therapeutic opportunities. Considering the stringent eligibility criteria, the screening process can result in high rate of screen failure (SF). We aimed to identify reasons for SF in patients who were initially deemed eligible and their prognostic factors.

Patients and methods

Patients with solid tumors who consented to participate in EPT yet screen failed between 2020 and 2022 across three French cancer centers were retrospectively included. We collected demographic data, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Royal Marsden Hospital (RMH) score upon signature, reason for SF and survival data.

Results

A total of 202 patients failed to enroll in EPT,

SUBMITTER: Korakis I 

PROVIDER: S-EPMC12362514 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature