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Strategic use of statistical thinking in drug development.

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Date
2000-12-15
Author
Rockhold, FW
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Abstract
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.
Type
Journal article
Subject
Drug Approval
Drug Design
Drug Industry
Humans
Statistics as Topic
Permalink
https://hdl.handle.net/10161/11026
Published Version (Please cite this version)
10.1002/1097-0258(20001215)19:23<3211
Publication Info
Rockhold, FW (2000). Strategic use of statistical thinking in drug development. Stat Med, 19(23). pp. 3211-3217. 10.1002/1097-0258(20001215)19:23<3211. Retrieved from https://hdl.handle.net/10161/11026.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Rockhold

Frank Wesley Rockhold

Professor of Biostatistics & Bioinformatics
Frank is a fulltime Professor of Biostatistics and Bioinformatics and Faculty Director for Biostatistics at Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Strategic Consultant at HunterRockhold, Inc.  His 40+-year career includes senior research positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer and Senior Vice President of Global Clinical Safety and Pharmacovigilance.  He has
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