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Area of Science:

  • Biostatistics
  • Clinical Trial Methodology
  • Survival Analysis

Background:

  • Group sequential methods are crucial for interim analyses in clinical trials.
  • Traditional methods for censored survival data may not optimally detect treatment benefits, particularly with delayed effects.

Purpose of the Study:

  • To propose an alternative group sequential method for two-sample tests of censored survival data.
  • To develop a new restricted means test and associated sequential methods for clinical trial monitoring.
  • To evaluate the performance of the proposed method compared to existing approaches.

Main Methods:

  • Repurposing censored event time data into a sequence of short-term outcomes from follow-up windows.
  • Developing a new two-sample restricted means test for restructured data.
  • Applying asymmetric error spending approaches for sequential stopping boundaries.
  • Conducting simulations and using an AIDS Clinical Trial Group example.

Main Results:

  • The proposed method favorably compares with existing group sequential monitoring methods for time-to-event outcomes.
  • The new approach performs well with delayed treatment effects and/or a subset of cured patients.
  • Asymmetric error spending approaches were considered to balance stopping for efficacy versus harm.

Conclusions:

  • The novel group sequential method offers an effective alternative for analyzing censored survival data in clinical trials.
  • This method enhances the evaluation of treatment benefit, particularly in complex scenarios like delayed effects or patient cure.
  • The study provides recommendations for selecting appropriate group sequential stopping boundaries.