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

Simultaneous testing strategy for comparing two treatments in a stratified binomial trial.

R A Railkar1, D V Mehrotra, B Iglewicz

  • 1Department of Statistics, Temple University, Philadelphia, Pennsylvania 19122, USA.

Journal of Biopharmaceutical Statistics
|August 26, 2000
PubMed
Summary

A new statistical method improves treatment comparisons in stratified trials by using two statistics, ZS and ZI. This approach is more powerful than the traditional Mantel-Haenszel procedure for analyzing clinical trial data.

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

Current Practices in Choosing Estimands and Sensitivity Analyses in Clinical Trials: Results of the ICH E9 Survey.

Therapeutic innovation & regulatory science·2018
Same author

Leveraging a Clinical Phase Ib Proof-of-Concept Study for the GPR40 Agonist MK-8666 in Patients With Type 2 Diabetes for Model-Informed Phase II Dose Selection.

Clinical and translational science·2017
Same author

An accessible pharmacodynamic transcriptional biomarker for notch target engagement.

Clinical pharmacology and therapeutics·2016
Same author

Rank-based principal stratum sensitivity analyses.

Statistics in medicine·2013
Same author

Vaccine clinical trials--a statistical primer.

Journal of biopharmaceutical statistics·2006
Same author

Statistical considerations for noninferiority/equivalence trials in vaccine development.

Journal of biopharmaceutical statistics·2006

Area of Science:

  • Biostatistics
  • Clinical Trials
  • Statistical Analysis

Background:

  • The Mantel-Haenszel (M-H) procedure is a standard method for comparing treatments in stratified binomial trials.
  • Its optimal performance relies on the assumption of a constant odds ratio across strata, which may not always hold true.

Purpose of the Study:

  • To propose a more powerful and robust analytic strategy for comparing two treatments in stratified binomial trials.
  • To introduce a novel approach that addresses the limitations of the M-H procedure when odds ratios vary across strata.

Main Methods:

  • Developed an alternative analytic strategy employing two statistics, ZS and ZI.
  • These statistics involve weighted averaging of within-stratum differences between proportions.
  • Significance is determined by comparing the minimum or maximum of these statistics against a data-dependent threshold.

Related Experiment Videos

Main Results:

  • The proposed strategy demonstrates greater statistical power compared to the Mantel-Haenszel procedure.
  • The method is effective even when the odds ratio is not constant across strata.
  • Numerical examples confirm the enhanced performance of the new approach.

Conclusions:

  • The proposed ZS and ZI statistic-based strategy offers a more powerful alternative for treatment comparisons in stratified binomial trials.
  • This method provides improved statistical efficiency, particularly in scenarios with heterogeneous odds ratios.
  • The findings suggest a valuable enhancement for clinical trial data analysis.