Tree-temporal scan statistics for safety signal detection in vaccine clinical trials.

ABSTRACT: The evaluation of safety is critical in all clinical trials. However, the quantitative analysis of safety data in clinical trials poses statistical difficulties because of multiple potentially overlapping endpoints. Tree-temporal scan statistic approaches address this issue and have been widely employed in other data sources, but not to date in clinical trials. We evaluated the performance of three complementary scan statistical methods for routine quantitative safety signal detection: the self-controlled tree-temporal scan (SCTTS), a tree-temporal scan based on group comparison (BGTTS), and a log-rank based tree-temporal scan (LgRTTS). Each method was evaluated using data from two phase III clinical trials, and simulated data (simulation study). In the case study, the reference set was ad

SUBMITTER: Haguinet F 

PROVIDER: S-EPMC11602958 | biostudies-literature | 2024 Nov-Dec

REPOSITORIES: biostudies-literature