Jaki T, Gordon A, Forster P, Bijnens L, Bornkamp B, Brannath W, Fontana R, Gasparini M, Hampson L V, Jacobs T, Jones B, Paoletti X, Posch M, Titman A, Vonk R, Koenig F
Lancaster University, Department of Mathematics and Statistics, Lancaster, UK.
Janssen Pharmaceutica NV, Beerse, Belgium.
Pharm Stat. 2018 Sep;17(5):593-606. doi: 10.1002/pst.1873. Epub 2018 Jul 9.
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.
本文概述了“改进早期药物研发研究的设计、评估与分析”（IDEAS）项目，这是一个由欧盟委员会资助的网络，汇集了顶尖学术机构以及从小型到大型的制药公司，旨在培养一批研究生水平的医学统计学家。该网络由分布在欧洲各地的公共和私营部门合作伙伴组成，将为14名早期研究人员提供为期36个月的资助。IDEAS培训活动由专业方法组件和通用可转移技能的全面组合构成。特别注重促进研究人员与导师之间的合作，这些合作跨越学术界和私营部门。在本文中，我们回顾了现有的医学统计学课程（硕士和博士），并强调了它们在与药物研发相关技能方面提供的培训。基于此次回顾以及我们在IDEAS项目中的经验，我们提出了一个联合、统一的欧洲博士项目概念，以培养在药物研发定量方法方面的统计学家。
