Strategic use of statistical thinking in drug development.
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 articlePermalink
https://hdl.handle.net/10161/11026Published Version (Please cite this version)
10.1002/1097-0258(20001215)19:23<3211Publication 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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Show full item recordScholars@Duke
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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