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

On sample size calculation based on odds ratio in clinical trials.

Hansheng Wang1, Shein-Chung Chow, Gang Li

  • 1StatPlus, Inc., Heston Hall, Suite 206, 1790 Yardley-Langhorne Road, Yardley, PA 19067, USA. hwang@statplusinc.com

Journal of Biopharmaceutical Statistics
|December 13, 2002
PubMed
Summary

This study provides sample size calculation formulas for odds ratio analysis in clinical trials, covering parallel and crossover designs for various hypotheses. Simulations confirm the formulas

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

Macrophage apoptosis in advanced atherosclerosis.

Annals of the New York Academy of Sciences·2009
Same author

Calcium/calmodulin-dependent protein kinase II links ER stress with Fas and mitochondrial apoptosis pathways.

The Journal of clinical investigation·2009
Same author

Cripto-1 overexpression is involved in the tumorigenesis of nasopharyngeal carcinoma.

BMC cancer·2009
Same author

Range of motion and orientation of the lumbar facet joints in vivo.

Spine·2009
Same author

[Silencing of COX-2 in nasopharyngeal carcinoma cells with a shRNAmir lentivirus vector].

Nan fang yi ke da xue xue bao = Journal of Southern Medical University·2009
Same author

The risk of melamine-induced nephrolithiasis in young children starts at a lower intake level than recommended by the WHO.

Pediatric nephrology (Berlin, Germany)·2009

Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Pharmacoeconomics

Background:

  • Accurate sample size calculation is crucial for the statistical power and validity of clinical trials.
  • Existing methods for sample size determination may not cover all hypothesis testing scenarios (equality, noninferiority, superiority, equivalence) based on odds ratios.
  • Both parallel and crossover study designs are commonly employed in clinical research, each with specific considerations for sample size.

Purpose of the Study:

  • To derive and present novel sample size calculation formulas for testing equality, noninferiority, superiority, and equivalence based on the odds ratio.
  • To illustrate the application of these formulas using a practical example in schizophrenia research.
  • To evaluate the performance and adequacy of the derived sample size formulas through simulations.

Related Experiment Videos

Main Methods:

  • Derivation of mathematical formulas for sample size calculations under parallel and one-arm crossover designs.
  • Application of derived formulas to a hypothetical clinical study comparing a test compound with standard therapy for schizophrenia relapse prevention.
  • Monte Carlo simulations to assess the accuracy and reliability of the proposed sample size formulas across different scenarios.

Main Results:

  • Formulas for sample size calculation were successfully derived for various hypothesis testing situations (equality, noninferiority, superiority, equivalence) using odds ratios.
  • The illustrative example demonstrated the practical implementation of these formulas for both parallel and crossover designs.
  • Simulation results indicated that the derived formulas provide adequate and reliable sample size estimations.

Conclusions:

  • The developed sample size calculation formulas offer a comprehensive tool for researchers designing clinical trials involving odds ratios.
  • These formulas are applicable to both parallel and crossover designs, enhancing flexibility in study planning.
  • The findings support the use of these formulas for ensuring appropriate sample sizes in studies evaluating treatment efficacy, particularly in psychiatric disorders.