IDEAS: improving design, evaluation and analysis of early drug development studies

Prof Thomas Jaki from the Medical and Pharmaceutical Statistics Research Unit at Lancaster University explores a novel approach to Ph.D. training for those in the pharmaceutical industry

The pharmaceutical industry is one of the main employers of statisticians hiring across all levels of education. According to Morgan (1999)1 in Switzerland, 40% of statisticians in the pharmaceutical industry do have a Ph.D. Despite this high demand for highly trained statisticians in the pharmaceutical industry, most existing Ph.D. programmes focus on pursuing a narrow research question and do not offer additional training relevant to someone working as a pharmaceutical statistician.

To provide tailored Ph.D. level training for someone aspiring to work as a statistician in (early) drug development, we have set up the IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies) network (www.ideas-itn.eu). It consists of 8 partners (3 industrial and 5 academics) from 7 European countries that work together to provide a unique Ph.D. programme. Together with several associated partners (largely from industry) it offers a programme that consists of:

1. Individually supervised research projects;
2. Transnational, cross-sectorial secondments;
3. Network-wide training activities and;
4. Individual training activities.

The individually supervised research projects form the core of the research undertaken by a student and focus on statistical challenges relevant to early drug development. Unlike the traditional model where the student is supervised by a single academic supervisor, students in IDEAS are supervised by at 2 experienced researchers, one working in academia while the other works in the industry. To complement the supervision a clinical advisor is associated with every project to ensure the practical utility of the work.

The transnational, cross-sectorial secondments are visits of the students to partner organizations of 3-12 months. The principle of these secondments is that students based at an industry partner spend the secondment with an academic partner and similarly students at an academic institution have their secondments at an industry partner. This allows students to experience both the academic as well as industry environment during their studies.

Besides the secondments, the second main place where students gain specialised knowledge relevant for drug development are the network-wide training activities. During their studies, students participate in 4 week-long training events and one think-tank. During these events students give updates on their project to receive critical feedback from the wider network, undertake specialist training relevant for drug development (e.g. dose-finding, regulation) and training in transferable skills (e.g. developing entrepreneurial skills, project management).

The final component of the programme is individual training. This training is used to develop the student further based on the specific needs of the individual. The exact training programme is developed with the supervisory team and forms the basis of a personal career development plan. The individual training activities range from career planning sessions via specialist courses to conference attendance.

Acknowledgement

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement No 633567 and by the Swiss State Secretariat for Education, Research and Innovation (SERI) under contract number 999754557. The opinions expressed and arguments employed herein do not necessarily reflect the official views of the Swiss government.

References

1 Morgan D. Qualified Statisticians in the European Pharmaceutical Industry: Report of a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) Working Group: EFSPI Working Group. Drug Information Journal. 1999 Apr;33(2):407-15.

Please note: this is a commercial profile

Prof Thomas Jaki

Professor of Statistics

Medical and Pharmaceutical Statistics

Research Unit

Lancaster University

Tel: +44 (0)1524 59 23 18

mps@lancaster.ac.uk

www.ideas-itn.eu