Assessing the Feasibility of Integrating Swedish Healthcare Data into Pharmaceutical Research and Development

Sammanfattning: Today, Real World Data (RWD) is a popular topic in many studies. In particular, it is anticipated to be a significant resource for addressing issues brought on by drug development costs, lengthy development times, and safety concerns. The Swedish healthcare Quality Registries (QR) are studied to contribute to the improvement of health care with individual-based clinical data. Recorded data is used for quality improvement, guidance compliance monitoring, and research. However, the workflow for such a framework that applies RWD which is patient-related data that came from various sources to the new drug development field is currently not well-defined. Thus the main aim of this project is to establish a strategy for integrating RWD with pharmaceutical modeling. To achieve this aim, QRs were examined through an ontological approach. The data and procedures necessary for modeling the development of new drugs, as well as the correspondence of the pieces offered by QR, were studied to assess the feasibility. The modeling of new drug development was studied for three applications: Adverse Drug Event (ADE), Computer-based Simulation (CBS), and drug repurposing, and the analysis of QRs was conducted on seven diseases. After in-depth analysis, although there were differences between the registries, it showed enough feasibility in terms of how much the data provided in the studies on drug repurposing and computer-based simulation satisfied the items required for new drug development. However, in the case of rare diseases, given the lack of an automated method, the ethical ambiguity, and the speed of the process, there still seems to be potential for improvement.  Many registries have begun to support research on the development of novel medications, such as by independently recording the features of drugs. These initiatives could enable the future potential of new Real World Evidence (RWE) such as in the field of proteomics and genomics discovery.