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Group sequential procedures for repeated events data with frailty.

¹Department of Statistics, Northwestern University, Evanston, Illinois 60208, USA.

Journal of Biopharmaceutical Statistics

|September 3, 1999

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This study introduces valid group sequential trial designs for heterogeneous populations with recurrent endpoints. It provides methods for planning studies, calculating sample sizes, and determining optimal trial duration for recurrent event data.

Area of Science:

Biostatistics
Clinical Trial Design
Survival Analysis

Background:

Standard group sequential trial methods assume independent increments, which are invalidated by subject heterogeneity.
Heterogeneity in study subjects, particularly with recurrent endpoints, complicates standard sequential analysis.
Previous work by Cook and Lawless highlighted the invalidity of usual procedures in heterogeneous populations.

Purpose of the Study:

To develop valid design aspects for group sequential trials with recurrent study endpoints in heterogeneous populations.
To investigate the impact of subject heterogeneity (frailty) on trial design using a Poisson process with frailty model.
To provide practical tools for study planning, including stopping boundaries and sample size computations.

Main Methods:

Related Experiment Videos

Utilized a Poisson process with frailty model to account for subject heterogeneity.
Developed and prescribed valid procedures for group sequential trials with recurrent endpoints.
Employed group sequential tests and repeated confidence intervals for methodology illustration.
Incorporated minimal cost analysis for optimizing study duration and sample size.

Main Results:

Established valid procedures for group sequential trials in heterogeneous populations with recurrent endpoints.
Provided convenient tables for calculating stopping boundaries and sample sizes.
Demonstrated the application of the methodology through an animal experiment with recurrent tumors.

Conclusions:

The proposed methods offer valid approaches for designing group sequential trials with recurrent events in heterogeneous populations.
The study provides practical guidance and computational tools for researchers planning such trials.
Optimal study planning involves balancing study duration and sample size, considering cost-effectiveness.