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Strategic use of statistical thinking in drug development.

dc.contributor.author Rockhold, FW
dc.coverage.spatial England
dc.date.accessioned 2015-12-03T17:47:42Z
dc.date.issued 2000-12-15
dc.identifier http://www.ncbi.nlm.nih.gov/pubmed/11113955
dc.identifier 10.1002/1097-0258(20001215)19:23<3211
dc.identifier.issn 0277-6715
dc.identifier.uri https://hdl.handle.net/10161/11026
dc.description.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.
dc.language eng
dc.publisher Wiley
dc.relation.ispartof Stat Med
dc.relation.isversionof 10.1002/1097-0258(20001215)19:23<3211
dc.subject Drug Approval
dc.subject Drug Design
dc.subject Drug Industry
dc.subject Humans
dc.subject Statistics as Topic
dc.title Strategic use of statistical thinking in drug development.
dc.type Journal article
duke.contributor.id Rockhold, FW|0668002
pubs.author-url http://www.ncbi.nlm.nih.gov/pubmed/11113955
pubs.begin-page 3211
pubs.end-page 3217
pubs.issue 23
pubs.organisational-group Basic Science Departments
pubs.organisational-group Biostatistics & Bioinformatics
pubs.organisational-group Duke
pubs.organisational-group Duke Clinical Research Institute
pubs.organisational-group Institutes and Centers
pubs.organisational-group School of Medicine
pubs.publication-status Published
pubs.volume 19
duke.contributor.orcid Rockhold, FW|0000-0003-3732-4765


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