A note on sample size calculation for mean comparisons based on noncentral t-statistics

J Biopharm Stat. 2002 Nov;12(4):441-56. doi: 10.1081/BIP-120016229.

Abstract

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.

MeSH terms

  • Algorithms
  • Anticholesteremic Agents / therapeutic use
  • Bone Diseases, Metabolic / drug therapy
  • Cholesterol, LDL / blood
  • Coronary Disease / prevention & control
  • Cross-Over Studies*
  • Data Interpretation, Statistical*
  • Drug Therapy
  • Female
  • Humans
  • Middle Aged
  • Osteoporosis / drug therapy
  • Research Design
  • Sample Size*
  • Therapeutic Equivalency

Substances

  • Anticholesteremic Agents
  • Cholesterol, LDL