Sample size justification in phase III/IV clinical trials.
A sample size justification is often a key component in securing funding to conduct a clinical trial. Sample size computations typically require supplying values of parameters that are unknown and subject to misspecification. As an alternative, we advocate a power analysis approach based on a range of reasonable values for such parameters. We illustrate this approach in the context of a secondary stroke prevention trial.
Richardson
D
D
AAASPS Data Management Center, Chicago, Ill. 60612, USA.
Leurgans
S
S
D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D016021:Epidemiologic Studies; D006801:Humans; D012107:Research Design; D018401:Sample Size