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Statistics versus statistical science in the regulatory process
Author(s) -
Longford Nicholas T.,
Nelder John A.
Publication year - 1999
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/(sici)1097-0258(19990915/30)18:17/18<2311::aid-sim257>3.0.co;2-t
Subject(s) - computer science , process (computing) , selection (genetic algorithm) , econometrics , value (mathematics) , connection (principal bundle) , statistical hypothesis testing , data science , management science , statistics , data mining , mathematics , economics , artificial intelligence , machine learning , geometry , operating system
Abstract This paper reviews the established practice of providing evidence to regulatory authorities about the claimed properties (such as efficacy and safety) of new pharmaceutical products. The established conventions and procedures are contrasted with scientific 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. Copyright © 1999 John Wiley & Sons, Ltd.