Unlocking the power of Danish Data Analytics Centre
“Denmark has a richness of healthcare data and registries that offer huge potential for the generation of real-world evidence. In medicines regulation this evidence can then support the development and supervision of medicines for the benefits of European patients. DKMA and its Analytics Centre are amongst the European trailblazers in the analysis of healthcare data to support better medicines for patients.”
More precise scientific advice
The Data Analytics Centre is the first of its kind in Europe, supporting regulatory decision-making as well as creating a globally unique research infrastructure also to be used by industry partners. With the Data Analytics Centre, the Danish Medicines Agency is able to offer more precise scientific advice to the pharmaceutical companies in the development of new medicines, including medicines for people with rare diseases or small patient groups.The key goal
The overall vision for the Data Analytics Centre is, through use of clinical trial and real world data and advanced analytical methods, to increase the accessibility of safe and affective medicines and medical devices. The purpose is to provide both the industry and academia i) better regulatory framework for scientific advises. ii) Give authorities access to applicants’ clinical trial data (CDISC formatted data) in the preapproval process, as well as conditional approvals expands. iii), and in the post-approval part, to give adverse drug reaction supplemented with real world data (RWD).Comprehensive registers and statistical databases
The centre is highly relevant in Denmark, since the public health service system includes numerous comprehensive registers and statistical databases of extremely high quality – not least Denmark’s national unique personal identifier system (Civil Registration Number or CPR). For 50 years, the Civil Registration Number is issued to all Danish citizens at birth and the citizens are subsequently registered in the public health service system. The Civil Registration Number ensures easy linkage to national registries.Collaboration with the industry
The Data Analytics Centre collaborates with the industry in relation to RWD among others. The RWD analysis, which DAC is currently involved in, is in collaboration with academia in Denmark. Furthermore, in collaboration with academia, DAC is currently doing medical device RWD analysis. Besides, DAC is doing pilot projects on both biostatistical analysis (CDISC data) and real time surveillance. More in-depth information about the Data Analytics Centre is available at DAC’s webpage.Unique opportunities for epidemiological research
The Danish Civil Registration Number system and the numerous statistical databases, registers and journal records offer unique opportunities for epidemiological research of extremely high quality. Given that the aforementioned registers have a long history in Denmark, Danish researchers also have a long tradition of performing register research, public health studies, and epidemiological research, all of which are important prerequisites for the identification and segmenting of relevant target segments and patient populations within personalized medicine.“One cohort”
When talking more specifically about epidemiology and the Danish registers, it is actually fair to say, that Denmark itself is a cohort. Denmark has gathered more data on its citizens than any other country. Now, Denmark wants to make this array of statistics even more useful. It is easy for Danish scientists to get safe and secure access to all the data in the registries through the websites “Statistics Denmark” and “The Danish Health Data Authority”, which works as single point of access for all the registries. Although Denmark has some of the best and oldest registries in the world, new registries are being development continually. Two of the newest developments are Laboratory values and In-hospital medicines.
With the development of the Data Analytics Centre, the regions and universities obtain secure, confidential, and flexible access to the use of health data. This means more accurate diagnostics and better treatment for the patient. The goal is more use of personalized medicine for the benefit of all patients.
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