Journal of biopharmaceutical statistics
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Historical Article
Biopharmaceutical statistics in a pharmaceutical regulated environment: past, present, and future.
The practice of statistics in the pharmaceutical industry has changed markedly over the last 25 years. This paper examines the evolution of clinical trial statistics in relationship to advances in statistical methodology and computational power as well as the changing regulatory environment. The current role of the biopharmaceutical statistician is assessed along with the drivers for future change.
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Recent literature has discussed the value of adjustment for important covariates in models involving nonnormal data. It is generally concluded that, when performing traditional "fixed sample size" clinical trials, covariate adjustment influences the magnitude of the treatment effect but has little effect on precision of the estimate. ⋯ Sequential and fixed sample analyses are compared, with and without covariate adjustment of the treatment effect. It was found that conclusions similar to those for the fixed sample size case also apply in the sequential case, but that incorporation of covariate information can present added complications in this setting.