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Evaluating Sample Size
Sample size a random variable
–Summary measures of distribution as a function
of treatment effect
•maximum
(feasibility of accrual)
•mean
(Average Sample N- ASN)
•median,
quartiles
–Stopping
probabilities
•Probability of stopping at each analysis as a
function of treatment effect
•Probability of each decision at each analysis
(Sponsor)
(Sponsor, DMC)
(Sponsor)