Real World Evidence are used to monitor the post-market safety and adverse events of drugs. The monitoring of this data assists in making regulatory decisions. The healthcare community is using RWE and RWD to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.
The shift from volume- to value-based care, delays in drug development (and the subsequent increase in development costs), growth in R&D spending, and support from regulatory bodies for the use of RWE solutions are some of the other major factors that are driving the growth of this market.
In this regard, RWE solutions have proven to be very helpful, as they allow industrial and academic researchers to monitor patients using digitally connected platforms while helping to organize and evaluate clinical data for regulatory submissions.
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RWE is set to become the most influential emerging technology to help in the fight against the COVID-19 outbreak, according to the latest poll on GlobalData’s Pharmaceutical Technology website. In this poll, which was completed by 935 of its readers in April 2021, more than one-third of the respondents indicated that RWE would have the greatest impact on the management of COVID-19.
RWE can provide valuable insights to better understand, monitor, and prepare for the challenges caused by outbreaks such as the COVID-19 pandemic. The utilization of RWE in infectious disease control is not a new concept. During the Ebola outbreak in 2014, forecasters successfully used Global Epidemic and Mobility (GLEaM) simulations that combined real-world data on populations and their mobility with rigorous stochastic models of disease transmission to predict the global spread of the disease.
Regulators use Real World Evidence to monitor the safety of marketed products through traditional pharmacovigilance tools (for instance, Periodic Benefit-Risk Evaluation Report, Periodic Safety Update Report, and Vaccine Adverse Event Reporting System) as well as newer digital aids such as the FDA Sentinel Initiative, a post-market active safety surveillance system.
