Real world data (RWD) are defined by FDA as “the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources” while real world evidence (RWE) is “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD” .
More broadly, RWD and RWE can be defined as health-related data / evidence obtained from multiple sources outside of traditional clinical research trials, and accordingly, RWE is typically valued based on its’ potential in complementing and validating clinical trial data .
Figure 1 highlights some selected examples and future visions on how RWD and RWE can be utilized, adopting a wider perspective on the possibilities. For example, utilization of RWE includes assessments of treatment needs, treatment paths and impact of an intervention on health status and quality of life. Growing data sources provide new opportunities in developing diagnostics for rare diseases and planning clinical trials. From a health economic point of view, RWE can be utilized to provide local resource and cost information and for comparison of costs and health effects between different treatments.
It seems likely that we have only begun to understand the full potential of RWE in decision-making and that many decisions will apply RWE in the future.
In Finland, we have unique opportunities in utilizing real world data. Our existing national registries, dating back to several decades, constitute the main data sources for nation-wide evaluations, while region-specific registry data provide means to review regional differences. The currently existing three national biobanks and six regional biobanks provide a valuable source of clinical data for biobank-based studies. Figure 2 illustrates the types of clinical data accessible from electronic patients records for such studies. Importantly, information between the various data sources can be interconnected through the national ID code, as illustrated further in figure 3.
To support the use of health and wellbeing data, several actions are currently ongoing in Finland. The main reform concerns the legislation and, subsequently, the launch of a new national service operator, which will serve as a “one-stop shop” for more straightforward and easier data access from multiple sources. Other ongoing actions include the establishment of the Finnish Biobank Cooperative, FINBB, supporting the development of biobanks, development of hospital data lakes and disease-specific registries, as well as efforts regarding the collection and use of genome data. Besides research, new possibilities of using RWE include decision-making, product development and innovations. These efforts will further advance the role of RWE in Finland and will undoubtedly attract attention also globally.
2. Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, et al. Real-world evidence – What is it and what can it tell us? NEJM, 375(23):2293-2297, 2016.