A note on sample size calculation for mean comparisons based on noncentral t-statistics.
Journal Article (Journal Article)
One-sample and two-sample t-tests are commonly used in analyzing data from clinical trials in comparing mean responses from two drug products. During the planning stage of a clinical study, a crucial step is the sample size calculation, i.e., the determination of the number of subjects (patients) needed to achieve a desired power (e.g., 80%) for detecting a clinically meaningful difference in the mean drug responses. Based on noncentral t-distributions, we derive some sample size calculation formulas for testing equality, testing therapeutic noninferiority/superiority, and testing therapeutic equivalence, under the popular one-sample design, two-sample parallel design, and two-sample crossover design. Useful tables are constructed and some examples are given for illustration.
Full Text
Duke Authors
Cited Authors
- Chow, S-C; Shao, J; Wang, H
Published Date
- November 2002
Published In
Volume / Issue
- 12 / 4
Start / End Page
- 441 - 456
PubMed ID
- 12477068
International Standard Serial Number (ISSN)
- 1054-3406
Digital Object Identifier (DOI)
- 10.1081/BIP-120016229
Language
- eng
Conference Location
- England