Sample Size Calculations in Clinical Research



Sample Size Calculations in Clinical Research
Shein-Chung Chow, Jun Shao, Hansheng Wang
CRC | 2003-03-04 | ISBN:0824709705 | 358 pages | PDF | 12,3 Mb



This text enforces statistical design procedures that ensure the validity, accuracy, reliability, and reproducibility of clinical studies. It illustrates formulas for sample size calculation with selected examples from studies on womens health, oncology, in vivo and in vitro bioequivalence, and the cardiovascular and central nervous systems. Topics of discussion include regulatory requirement, considerations prior to sample size calculation, confounding and interaction, crossover design versus parallel design, subgroup/interim analyses, Fishers exact test, tests for goodness-of-fit and contingency tables, Coxs proportional hazards model, and comparing variabilities.


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