Bringing methodology to a higher level
16 March 2017
Partnership agreement between Julius Center and MEB. The Dutch Medicines Evaluation Board (MEB) assesses and monitors the efficacy, risks and quality of medicines.
Thanks to a recently concluded partnership agreement with the Julius Center, the MEB will be able to bring its knowledge of clinical research methodology to a higher level. For the Julius Center, part of University Medical Center (UMC) Utrecht, the partnership provides a stimulus for the application and further development of methodology for research into medicines.
Prof. Kit Roes, Professor in Clinical Trials Methodology and affiliated with the Julius Center: ‘Two staff members of the Julius Center will be seconded to the MEB’s methodology group. They will assist in the evaluation of drug files and give scientific advice to corporations on the methodological aspects of the research required to develop medicines. I myself will join this group one day a week to oversee the methodological aspects of their work. In addition, I will provide input for the discussions currently ongoing at the European level, including in the Biostatistics Working Party of the European Medicines Agency.’
‘The MEB has also asked us to share ideas on the methodological challenges that exist in the development of medicines. For example, a great deal of high-quality research is conducted before a new drug is put on the market. But once a drug is on the market, far less research is done. That raises questions such as: Could you accelerate and widen the availability of medicines for rare diseases and extend the period of thorough research? We can share ideas on the methodological consequences of such adaptive pathways and link that to research into methodology.’
The focus is not only on new drugs, but also on drugs already on the market for which safety concerns have been highlighted. ‘That issue is currently not sufficiently considered in terms of methodology. The Julius Center can help in better interpreting such concerns and assessing their severity,’ says Kit Roes.
‘An experimental drug should have as few side effects for patients as possible and be accompanied by the best possible information when it is put on the market. By gate keeping, the MEB can monitor the safety of patients. At the same time, where possible, the MEB wants to ensure that truly valuable medicines are put on the market quickly. Methodology has a big impact on that balance.’
Biostatisticians and clinical epidemiologists from the Julius Center will make a contribution to training by developing a standard curriculum for the MEB’s clinical assessors. Through class-based courses or e-learning, they will be imparted with the methodological tools they need in their work.