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Strategic use of statistical thinking in drug development
Author(s) -
Rockhold Frank W.
Publication year - 2000
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 - 10.1002/1097-0258(20001215)19:23<3211::aid-sim622>3.0.co;2-f
Subject(s) - statistician , pace , computer science , management science , statistical thinking , pharmaceutical industry , drug development , regulatory affairs , face (sociological concept) , range (aeronautics) , data science , engineering ethics , operations research , operations management , sociology , economics , psychology , medicine , engineering , social science , mathematics , drug , statistics , geodesy , aerospace engineering , psychiatry , pharmacology , geography
The role of the statistician and statistical thinking in the pharmaceutical industry has evolved greatly in the last four or five decades. Regulatory developments and the changing face of the science of drug development have driven this evolution. The increasing regulatory requirement for statistical input in critical areas has facilitated a wider range of applications. The pace of change of science in general has brought statisticians into contact with a wider range of potential customers. More importantly, it has allowed the statistician to become increasingly involved in strategic issues with the possibility of influencing the direction of the business. However, it is not clear that the statistical profession in industry is adequately prepared for these opportunities either in attitude or training. Changing the statisticians' approach to their role and acquiring the correct training and experience are critical for the profession to optimize their contribution to the drug discovery and development processes. Copyright © 2000 John Wiley & Sons, Ltd.