In the Medaffcon customer evening organised in April 2017, we went through data sources related to real world data on health and well-being and brought up some concrete examples on how the data could be used. In addition, we discussed how the field of data sources will change in the near future along with several projects preparing more extensive and effective usability of health and well-being data.
Real world evidence (RWE) to support decision-making
RWE is derived from real world data (RWD), i.e. data collected about an individual. This information can be used for a wide variety of purposes. Clinical data based RWE can be utilised, for example, in assessing the treatment paths and treatment recommendations of diseases and in reviewing the need for treatment. Growing data resources provide valuable information for improving diagnostics, which creates new potential, particularly with regard to rare diseases. RWE can also be utilised in assessing the clinical value of a product and in planning clinical trials. The collected data also contributes to the evaluation of change in health status or quality of life after a procedure or treatment. From a health economic perspective, RWE can be used for creating local resource and cost information, that can be further utilised in economic evaluations, e.g. when comparing the costs and health effects of different treatments. Accounting for regional differences and individual background information such as socioeconomic differences brings depth to the evaluations.
The widening range of RWE sources
The field and perspective of decision-making determine the data sources to be used. By utilising national data sources, evaluations can be made at the level of the entire Finland, while also reviewing regional differences, if needed. Regional sources provide precise region-specific data. Other data sources complement the evaluations or serve as data sources as such. Data sources at different levels can be utilised in parallel.
The clinical data sources include electronic patient records, biobanks as well as hospital data lake accessible by the Turku Centre for Clinical Informatics, operating in the hospital district of Southwest Finland. The oldest regional biobank in Finland, Auria Biobank, operating in the hospital district of Southwest Finland, has constituted, together with the Centre for Clinical Informatics, a strong and functional concept. This has also in practice had an influence on the various biobank-based research projects coordinated by Medaffcon. Lately, other regional biobanks have also developed substantially, and valuable sample collections that were collected before the entry into force of the Biobank Act, have been transferred to several biobanks, while new sample collections have also been launched. In addition to regional biobanks, two national biobanks operate in Finland, THL Biobank and the Finnish Hematology Registry and Clinical Biobank, FHRB.
Research and genome data provide valuable information when examining the underlying molecular mechanisms and individuals’ genotype-related risks for diseases, as well as in preventing disease onset and planning individualised treatment. Drug development benefits from the information on individuals’ differences at the molecular level and other information provided by the new research methods, e.g. ex vivo drug sensitivity of patient-derived cells. The availability of research and genome data improves as the samples from biobanks are used in research and the sample-specific research results are returned to the biobank. Even now, THL Biobank includes a significant amount of genome data.
One interesting future direction is the development of P4 medicine, which refers to Predictive, Preventive, Personalized and Participatory Medicine. With this development, as also generally in the current era of increasing use of self-monitoring applications, individual’s own role as data producer and utiliser is becoming more and more pronounced.
From a fragmented system towards an organized ecosystem
Currently, permissions for person-level data of e.g. THL, Statistics Finland and Kela must be separately applied from these permission authorities. In Isaacus project coordinated by Sitra, preparations have been conducted, preproduction projects have been tested and a plan of action has been constructed for a new national actor that collects, combines and analyses well-being and health data from different registers and sources. The operation of the well-being service operator is set to be launched already next year, and from a user’s perspective, such “one-stop shop” service is extremely welcome improvement compared to the fragmented current situation. Other reforms are also expected; there are active preparations for establishing a common institution for biobanks in Finland, a biobank cooperative, which further strengthens the development of biobanks at both national and international level. Data lakes are constructed in hospital districts and disease-specific registries improve the monitoring of treatment effectiveness and quality. Regarding genome data, a decision to establish a national genome centre has been made. We are in the middle of great development and new potential for utilising RWE awaits us!
Medaffcon is up-to-date with the development
Along with the changes now taking place, Finland can even better utilise up-to-date health data that can be connected into coherent entities. While the number of time-consuming permission processes decreases, we can even better focus on actual scientific questions and come up with new and innovative ways of utilizing RWE data. This means new opportunities for all of us.
PhD, Docent in Molecular Medicine
+358 40 572 0615
MSc (Econ), MSc (Health Econ)
+358 50 3286 651