Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Confidence intervals following group sequential tests in clinical trials.

K Kim1, D L DeMets

  • 1Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts 02115.

Biometrics
|December 1, 1987
PubMed
Summary

This study extends confidence interval methods for group sequential tests with unequal sample sizes or spacing. Simulations evaluate the procedure

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Statistical issues in interpreting clinical trials.

Journal of internal medicine·2004
Same author

Considerations in the evaluation of surrogate endpoints in clinical trials. summary of a National Institutes of Health workshop.

Controlled clinical trials·2001
Same author

Statistical issues relating to international differences in clinical trials.

American heart journal·2001
Same author

Effect of carvedilol on survival in severe chronic heart failure.

The New England journal of medicine·2001
Same author

The Data and Safety Monitoring Committee: Some final thoughts.

American heart journal·2001
Same author

An overview of group sequential methods in longitudinal clinical trials.

Statistical methods in medical research·2001

Area of Science:

  • Biostatistics
  • Statistical Inference
  • Clinical Trial Design

Background:

  • Group sequential tests allow early stopping of clinical trials based on accumulating data.
  • Accurate confidence intervals are crucial for estimating treatment effects after sequential analysis.
  • Existing methods by Tsiatis, Rosner, and Mehta (1984) assume equally spaced analyses and sample sizes.

Purpose of the Study:

  • To extend the Tsiatis, Rosner, and Mehta confidence interval procedure for flexible group sequential designs.
  • To evaluate the properties of the extended confidence interval estimation procedure via simulation.
  • To integrate flexible boundary construction (Lan and DeMets, 1983) with confidence interval estimation.

Main Methods:

  • Extension of the Tsiatis et al. confidence interval procedure to accommodate non-identical sample sizes and unequal time intervals between analyses.
  • Simulation studies to assess the performance and properties of the proposed confidence interval estimation.
  • Integration of the Lan and DeMets (1983) approach for adaptive group sequential boundary construction.

Main Results:

  • The proposed extension successfully adapts the confidence interval construction for irregular group sequential designs.
  • Simulation results demonstrate the reliability of the extended confidence interval procedure.
  • A FORTRAN program is developed to combine the Lan and DeMets and Tsiatis et al. methodologies.

Conclusions:

  • The extended confidence interval procedure provides a robust method for flexible group sequential trials.
  • This work enhances statistical inference capabilities in adaptive clinical trial designs.
  • The developed program facilitates practical implementation of these advanced statistical methods.

Related Experiment Videos