✦ LIBER ✦

Statistics versus statistical science in the regulatory process

✍ Scribed by Nicholas T. Longford; John A. Nelder

Publisher: John Wiley and Sons
Year: 1999
Tongue: English
Weight: 93 KB
Volume: 18
Category: Article
ISSN: 0277-6715
DOI: 10.1002/(sici)1097-0258(19990915/30)18:17/18<2311::aid-sim257>3.0.co;2-t

No coin nor oath required. For personal study only.

✦ Synopsis

This paper reviews the established practice of providing evidence to regulatory authorities about the claimed properties (such as e$cacy and safety) of new pharmaceutical products. The established conventions and procedures are contrasted with scienti"c concepts and principles. The following issues are discussed: (a) recruitment of subjects and its connection to treatment heterogeneity; (b) the measurement process and the handling of missing data; (c) data transformation and the use of generalized linear models; (d) model selection and model checking; (e) the &cult of the single trial' and the use of prior information; and (f ) hypothesis testing and the P-value culture.

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