Analysis and discussion on the subject screening failure in Phase Ⅰ clinical trial

Abstract

Objective To explore and analyze the reasons on the failure of subjects screening in Phase Ⅰ clinical trials. Methods The subjects screening data of 10 Phase I clinical trials conducted from February 2019 to December 2020 were summarized, and the reasons of screening failure were classified and analyzed to explore the possible influencing factors. Results The reasons of screening failure included laboratory examinations, other auxiliary examinations except the laboratory, vital signs and physical examination, compliance, etc. The main reasons were unqualified laboratory examinations(36.61%) and other auxiliary examinations(31.35%). Conclusion Scientific judgment of abnormal values in physical and chemical examinations, emphasis on recruitment, careful screening, establishment of a subject database, and strengthening of subject compliance management are effective measures to improve the pass rate of subject screening in Phase I clinical trials.

Keywords

• phase i clinical trial
• subject screening
• screening failure
• laboratory examination
• healthy subjects