When Is Stratification Detrimental to a Clinical Trial Design? Part I. Gretchen Marcucci, M.S . Biostatistician, Rho, Inc . and Katherine L. Monti, Ph.D. Rho, Inc. and University of North Carolina. Outline. Introduction Motivation for the literature search Why stratify? Advantages
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When Is Stratification Detrimental to a Clinical Trial Design?Part I
Gretchen Marcucci, M.S.
Biostatistician, Rho, Inc.
Katherine L. Monti, Ph.D.
Rho, Inc. and University of North Carolina
Perfect balance with 4 treatments.
If you want to stratify …
How many strata depends on:
If stratification is not done at randomization, covariate analysis can be performed.
Consider stratifying only if:
Authors are still (1999) concluding that “Stratification is … harmless always, useful frequently, and important rarely”. (Kernan et. al., 1999)
The preconception that stratification would improve the balance and could not hurt should be reconsidered.