Sample size estimation: a glimpse beyond simple formulas.

Small increments in the complexity of clinical studies can readily take sample size estimation and statistical power analysis beyond the capabilities of simple mathematic formulas. In this article, the method of simulation is presented as a general technique with which sample size may be calculated for complex study designs. Applications of simulation for determining sample size requirements in studies involving correlated data and comparisons of receiver operating characteristic curves are discussed. Copyright RSNA, 2004