Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process.

ABSTRACT:

Background

To analyze the main reasons for screening failure in the screening process of healthy subjects in phase I clinical trials and coping strategies.

Methods

We retrospectively collected data from the screening process of 1,640 healthy subjects in 12 phase I clinical trials conducted between April 2019 and July 2020 at the First Affiliated Hospital of Bengbu Medical College. The reasons for screening failure were statistically analyzed (χ² test), and correlation studies were conducted to explore the main factors associated with screening failure.

Results

Among the 1,640 healthy subjects, 632 (38.5%) successfully passed screening, and 1,008 (61.5%) failed screening. Abnormal laboratory test results (43.25%), abnormal vital sign examination results (11.

SUBMITTER: Li B 

PROVIDER: S-EPMC8576730 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature