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. 2018 Sep;17(5):593-606.
doi: 10.1002/pst.1873. Epub 2018 Jul 9.

A proposal for a new PhD level curriculum on quantitative methods for drug development

T Jaki  1 , A Gordon  1 , P Forster  1 , L Bijnens  2 , B Bornkamp  3 , W Brannath  4 , R Fontana  5 , M Gasparini  5 , L V Hampson  3 , T Jacobs  2 , B Jones  3 , X Paoletti  6 , M Posch  7 , A Titman  1 , R Vonk  8 , F Koenig  7
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A proposal for a new PhD level curriculum on quantitative methods for drug development

T Jaki et al. Pharm Stat. 2018 Sep.

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.

Keywords: PhD curriculum; development of early-stage researchers; drug development; regulatory statistics; university-industry partnership.

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References

    1. The IDEAS Blogs: the role of a statistician in drug development. Available at http://www.ideas-itn.eu/ideas-blog/(last accessed 2017–02‐15).
    1. Eichler HG, Bloechl‐Daum B, Brasseur D, et al. The risks of risk aversion in drug regulation. Nat Rev Drug Discov. 2013;12(12):907‐916. - PubMed
    1. Bauer P, König F. The risks of methodology aversion in drug regulation. Nat Rev Drug Discov. 2014;13(5):317‐318. - PubMed
    1. Pinheiro J, Bornkamp B, Glimm E, Bretz F. Model‐based dose finding under model uncertainty using general parametric models. Stat Med. 2014;33(10):1646‐1661. - PubMed
    1. Hilgers RD, Roes K, Stallard N. Directions for new developments on statistical design and analysis of small population group trials. Orphanet J Rare Dis. 2016;11(1):78 10.1186/s13023-016-0464-5 - DOI - PMC - PubMed

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