دورية أكاديمية

Sample Size Calculation for Comparing Two Poisson or Negative Binomial Rates in Noninferiority or Equivalence Trials.

التفاصيل البيبلوغرافية
العنوان: Sample Size Calculation for Comparing Two Poisson or Negative Binomial Rates in Noninferiority or Equivalence Trials.
المؤلفون: Zhu, Haiyuan1 (AUTHOR)
المصدر: Statistics in Biopharmaceutical Research. Jan-Mar2017, Vol. 9 Issue 1, p107-115. 9p.
مصطلحات موضوعية: *CLINICAL trials, *MEDICAL research
مستخلص: Poisson and negative binomial models are frequently used to analyze count data in clinical trials. While several sample size calculation methods have recently been developed for superiority tests for these two models, similar methods for noninferiority and equivalence tests are not available. When a noninferiority or equivalence trial is designed to compare Poisson or negative binomial rates, an appropriate method is needed to estimate the sample size to ensure the trial is properly powered. In this article, several sample size calculation methods for noninferiority and equivalence tests have been derived based on Poisson and negative binomial models. All of these methods accounted for potential over-dispersion that commonly exists in count data obtained from clinical trials. The precision of these methods was evaluated using simulations. Supplementary materials for this article are available online. [ABSTRACT FROM PUBLISHER]
قاعدة البيانات: Academic Search Index
الوصف
تدمد:19466315
DOI:10.1080/19466315.2016.1225594