Success with use of real world data in medicines research: Joining the dots of the European ecosystem (Guest blog)

recent survey in England indicated that, during the COVID-19 pandemic, the public had learned more about how real world data (RWD) can be used both for monitoring public health and for research. Words such as epidemiology and vaccine effectiveness now trip off the tongue and are no longer the preserve of scientists. From society’s perspective, real world evidence (RWE) has arrived.

However for the pharmaceutical industry RWE (clinical evidence about diseases and health interventions derived by scientific analysis of RWD) is not the new kid on the block.  Nevertheless the exciting growth of new data sources and complex analytical methodology (including artificial intelligence) means that its prominence in decision making of stakeholders is on the rise. A recent EMA report indicates that RWE was included in about a third of 63 innovative marketing authorisation applications (pre-authorisation), received in 2018 and 2019, with an exclusively supportive role in the benefit-risk assessment in three quarters of cases.  Moreover, many of the research questions that can be answered using RWD cannot be addressed by other means.

Read the full blog on the EHDEN website.

Karin Van Baelen

Karin Van Baelen is Head Global Regulatory Affairs, Janssen, the Pharmaceutical Companies of Johnson & Johnson...
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