Sequential monitoring of time-to-event safety endpoints in clinical trials.

ABSTRACT: Background/aimsSafety monitoring is a crucial requirement for Phase II and III clinical trials. To protect patients from toxicity risk, stopping rules may be implemented that will halt the study if an unexpectedly high number of events occur. These rules are constructed using statistical procedures that typically treat the toxicity data as binary occurrences. Because the exact dates of toxicities are often available, a strategy that handles these as time-to-event data may offer higher power and require less calendar time to identify excess risk. This work investigates several statistical methods for monitoring safety events as time-to-event endpoints and illustrates our R software package for designing and evaluating these procedures.MethodsThe performance metrics of safety stopping rules

SUBMITTER: Martens MJ 

PROVIDER: S-EPMC12096354 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature