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Related Experiment Videos

SEQPWR and SEQOPR: computer programs for design of maximum information trials based on group sequential logrank tests

K Kim1

  • 1Department of Biostatistics, Harvard School of Public Health, Boston, MA 02115, USA.

Computer Methods and Programs in Biomedicine
|February 1, 1995
PubMed
Summary

This study introduces software for designing maximum information clinical trials. These trials maximize accrued data by continuing until a set number of events, aiding in robust analysis of failure time data.

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Area of Science:

  • Clinical Trial Design
  • Biostatistics
  • Survival Analysis

Background:

  • The maximum information trial paradigm is a recognized approach for clinical trials involving failure time data.
  • This paradigm aims to maximize accrued data by continuing a study until a prespecified number of events (maximum information) occurs, unless early stopping criteria are met.

Purpose of the Study:

  • To present two interactive FORTRAN programs designed for the planning of maximum information trials.
  • These programs facilitate the use of group sequential logrank tests in trial design.

Main Methods:

  • The program SEQPWR calculates the statistical power of group sequential logrank tests based on specified accrual and follow-up durations.
  • The program SEQOPR enables users to explore the operating characteristics of maximum information trials by varying information fractions for interim analyses.

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  • Illustrative use of these programs is demonstrated with an Eastern Cooperative Oncology Group clinical trial.

    • Main Results:

    • The presented programs offer practical tools for designing maximum information trials.
    • SEQPWR provides power calculations, while SEQOPR aids in understanding trial behavior under different interim analysis scenarios.
    • The example trial showcases the utility and features of the developed software.

    Conclusions:

    • Interactive software tools are now available to assist researchers in designing maximum information clinical trials using group sequential logrank tests.
    • These programs enhance the ability to plan trials that efficiently accrue maximum information for failure time data analysis.