Strategic use of statistical thinking in drug development.
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.
Duke Scholars
Published In
DOI
ISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Statistics as Topic
- Statistics & Probability
- Humans
- Drug Industry
- Drug Design
- Drug Approval
- 4905 Statistics
- 4202 Epidemiology
- 1117 Public Health and Health Services
- 0104 Statistics
Citation
Published In
DOI
ISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Statistics as Topic
- Statistics & Probability
- Humans
- Drug Industry
- Drug Design
- Drug Approval
- 4905 Statistics
- 4202 Epidemiology
- 1117 Public Health and Health Services
- 0104 Statistics