EHDEN - D1.4 - Development of an EHDEN Academy Course on Implementation of RMM Effectiveness Testing Methods

The EHDEN Academy (academy.ehden.eu) is an online educational resource for anyone working in the domain of real world data and real world evidence. Originating in the European Health Data & Evidence Network (EHDEN) IMI2 project, its goal is to build upon the foundations of that project and its collaboration with the Observational Health Data Science and Informatics (OHDSI). The EHDEN Academy offers a number of courses related to real world data harmonisation and analysis using standardised analytical tools and infrastructure.

In this work a new EHDEN Academy course on “Methods for time series analysis, with application to Risk Minimisation Measures (RMM) Effectiveness Testing” has been developed. RMM are used by regulatory authorities to ensure and improve the safe use of a drug once it has been approved for use. Typical examples of RMM include changes in the conditions of marketing authorisation and/or changes in the conditions of use or label characteristics. Evaluating the impact of such regulatory measures is needed to measure immediate as well as long-term effects on drug uptake and use in the community.

The course covers basics of change point detection theory for examining trends over time and its application to testing the effectiveness of risk minimisation measures. Users learn how to apply change point detection methods using an interactive online tool. The tool enables users to select from a range of time-series change detection methods to a) determine the effect of known interventions/changes, and b) to detect plausible changes, in a data-driven manner. Users can select the time-series, methods, and interventions of interest and view the results of the RMM test in real-time. A demo is included showing the changes over time in the use of drugs for COVID-19 treatment.