Strategic use of statistical thinking in drug development.
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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.
Published Version (Please cite this version)10.1002/1097-0258(20001215)19:23<3211
Publication InfoRockhold, Frank Wesley (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 http://hdl.handle.net/10161/11026.
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Professor of Biostatistics & Bioinformatics
Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. In addition his role of full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute, Frank is also Managing Partner of HunterRock