A proposal for a new PhD level curriculum on quantitative methods for drug development |
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| Authors: | T. Jaki A. Gordon P. Forster L. Bijnens B. Bornkamp W. Brannath R. Fontana M. Gasparini L.V. Hampson T. Jacobs B. Jones X. Paoletti M. Posch A. Titman R. Vonk F. Koenig |
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| Affiliation: | 1. Lancaster University, Department of Mathematics and Statistics, Lancaster, UK;2. Janssen Pharmaceutica NV, Beerse, Belgium;3. Novartis Pharma AG, Basel, Switzerland;4. University of Bremen, KKSB and IfS Faculty 3 – Mathematics/Computer Science, Bremen, Germany;5. Politecnico di Torino, Turin, Italy;6. INSERM CESP‐OncoStat Institut Gustave Roussy & Université Paris‐Saclay UVSQ & Service de Biostatistique et d'Epidémiologie, Gustave Roussy, Villejuif, France;7. Medical University of Vienna, Center for Medical Statistics, Informatics, and Intelligent Systems, Vienna, Austria;8. Bayer AG, Berlin, Germany |
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| Abstract: | This paper provides an overview of “Improving Design, Evaluation and Analysis of early drug development Studies” (IDEAS), a European Commission–funded network bringing together leading academic institutions and small‐ to large‐sized pharmaceutical companies to train a cohort of graduate‐level medical statisticians. The network is composed of a diverse mix of public and private sector partners spread across Europe, which will host 14 early‐stage researchers for 36 months. IDEAS training activities are composed of a well‐rounded mixture of specialist methodological components and generic transferable skills. Particular attention is paid to fostering collaborations between researchers and supervisors, which span academia and the private sector. Within this paper, we review existing medical statistics programmes (MSc and PhD) and highlight the training they provide on skills relevant to drug development. Motivated by this review and our experiences with the IDEAS project, we propose a concept for a joint, harmonised European PhD programme to train statisticians in quantitative methods for drug development. |
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| Keywords: | development of early‐stage researchers drug development PhD curriculum regulatory statistics university‐industry partnership |
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