PURPOSE: The Covid-19 pandemic has disrupted all aspects of healthcare delivery and generated controversy in matters related to disease prevention, treatment options, and even reporting of events. At the same time, the pandemic has shown that drugs and vaccines can be developed, approved, and marketed in one year, instead of the usual 10-15 years. This may put greater importance on and increases the value of real-world data (RWD). The objective of this workshop is to highlight the unique opportunities and challenges of using RWD during the Covid-19 pandemic. Particular attention will be given to the use of electronic health records (EHR) and health insurance claims as alternative or additional data sources compared to data used by local and central governments.

DESCRIPTION: This workshop will start by giving a broad overview of the different types of RWD that can be used for Covid-19 research (10 min). This is followed by discussing the unique challenges of building fit-for-purpose real-world datasets from health insurance claims or EHRs of Covid-19 patients (20 min). The next 10 minutes will be used to review some of the regulatory aspects of RWD in the Covid-19 era. Next, an overview of the opportunities of using RWD for Covid-19 research are discussed. The audience will select through real-time polling what use cases of RWD in Covid-19 research should be presented (15 min), with topics including for example the natural history of Covid-19; uptake and effectiveness of Covid-19 vaccines in the post-marketing setting; medical cost related to the Covid-19 crisis; consequences of the pandemic for the execution of clinical trials of non-Covid-19 drugs; and under-utilization of routine healthcare services. The last 5 minutes will be used to discuss any other challenges and opportunities in the use of RWD for Covid-19 research that are put forward by the audience.