Danish Medicines Agency’s Data Analytics Center (DAC)
Better medicines and medical devices based on advanced data applications
The volume of data and the capacity to process data are growing exponentially. At the same time, the digital, physical and biological worlds are merging more and more when it comes to medicines and medical devices.
It offers unprecedented opportunities:
- First of all, medicines and medical devices with enhanced health-beneficial effects can be developed much faster for patients.
- Secondly, it will become easier to monitor whether the medicines and medical devices used in the real world achieve the efficacy and safety that were demonstrated in clinical trials.
Against this background, a new Data Analytics Center is being established within the Danish Medicines Agency.
The new Data Analytics Center (DAC) will enable the Danish Medicines Agency to offer more precise scientific advice to the pharmaceutical companies on the development of new medicines, including medicines for people with rare diseases and small patient groups. As an example, it has always been cost-intensive and very difficult to develop medicines for special diseases affecting children, one of the reasons being that it has proven extremely difficult to recruit enough trial subjects for conventional clinical trials in a single country.
Close collaboration with other authorities and the research environment
With the Danish Medicines Agency’s Data Analytics Center, which will be among the first of its kind in Europe, Denmark will gradually develop its expertise in the area. Over a period of years and in close collaboration with other authorities and the research environment, the Danish Medicines Agency will fulfil its ambition of becoming one of the best qualified drug regulatory authorities in Europe to analyse and apply these major and new data sets for the benefit of the general public and society.
The Data Analytics Center will provide better ways to ensure that the assessment of efficacy and safety of medicines based on data from the companies also proves accurate in the ‘real’ world, that is, after the trial phase has finished, and patients outside the research environment start taking the medicine. In addition, the center will make safety monitoring of medicines and medical devices more fine-meshed because the new methods and the approach to large data sets will catch adverse reactions that will not appear until after larger populations start using the medicines and medical devices.
Finally, the Data Analytics Center will set a regulatory framework for these data in terms of how they are obtained, protected and used in the interest of public health and in line with data-ethical standards.
The Data Analytics Center and its various types of analyses will be developed gradually over the coming years. We are thinking big but will take simple steps in the beginning while we develop the skills, cooperative relations, technology and legal basis.
The Data Analytics Center is expected to open officially in 2020.