A new £2.7 million international training network project, led by a team at Lancaster University, will develop a generation of medical statisticians dedicated to achieving early stage drug development success.
The four-year research and training initiative, which has attracted funding from the European Union, is due to get underway next year.
IDEAS (Improving Design, Evaluation and Analysis of Early Drug Development) is led by Dr Thomas Jaki, who heads up Lancaster University’s Medical and Pharmaceutical Statistics Research Unit.
“Recently, it has been recognised that more care needs to be taken during the early stages of drug development to avoid lengthy and costly confirmatory studies in the final stages with ineffective or even harmful treatments,” explains Dr Jaki.
“It is essential to implement efficient methods for the design and analysis of such early development studies. The expertise in this area is, however, limited at the moment and adequate methodology is only partially available.”
The network brings together eight partners from across Europe - universities, research institutes and pharmaceutical companies - to get the training network off the ground.
The network will provide places for 14 PhD students working in early drug development across Europe. They will work individually with joint training activities and interactions which will include cross sector internships.
Cross-sector, transnational research teams will support the student researchers with individual projects and devise tailored training programmes for each of them.
High-profile clinical advisors and industry regulators will support the supervisory teams to ensure practical relevance and implementation of the methods devised.
At the end of their training the students will be uniquely qualified with expertise in the field, benefit from public and private sector experience and will be able to rely on a network of subject experts.
“This approach will result in leading researchers with in depth understanding of the demands of the public and private sector and experience in training to educate, promote and support the future leaders in medical statistics and, in particular, in the design and analysis of early developmental studies,” added Dr Jaki.
“This is about what we can do to make sure information from pre-clinical studies is being used efficiently in human studies and how we design further studies. We want to make sure what is developed can be used in practice to provide a closer link to end users.”
- Lancaster University’s Medical and Pharmaceutical Statistics Research Unit develops and evaluates novel statistical methods of study design and data analysis for use in the pharmaceutical and medical research community. It works with partners in health care, the public sector and pharmaceutical industry and undertakes methodological research for companies and provides professional development courses and a consultancy service.