Real World Evidence Are Used To Monitor The Post Market Safety and Adverse Events of Drugs

The emergence of this pandemic has posed severe financial constraints on pharma-biopharma companies in several countries. 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.


The uncertainty brought on by the COVID-19 pandemic has dramatically shifted how and when patients decide to seek medical care. In addition, shifts in healthcare coverage and provision during the pandemic have changed the discovery and reporting of certain outcomes in data and the treated population. This means that disease trends may lead to incorrect interpretations when RWD and RWE are not framed in the context of the pandemic and long-term COVID-19 disease, therapy, and lifestyle changes.  


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. 


Even though emerging technologies, such as telemedicine, have existed for decades, most of healthcare systems rely heavily on in-person interactions between patients and clinicians. Nevertheless, the current requirement for social distancing measures is swiftly pushing the primary care provision toward remote care. Telemedicine and virtual care may also prompt a greater adoption of technologies such as wearables and digital therapeutics, thus accelerating digitalization in the healthcare space and boosting the importance of RWE and AI. 


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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. 


In countries with strict data privacy laws, the implications of contact-tracing apps on individual privacy are considered a major associated concern. While cryptographers are currently working on improving tracing apps to address the issue, tracking apps can only be effective when they are used by a significant proportion of the population. Therefore, it is critical that the functionality and safety of these applications are considered acceptable by the majority of the population. 


Through the analysis of the data generated from various networks, healthcare organizations can benefit from sensible information, resulting in real-time disease monitoring and control. However, as the use of technology as a means to produce more and more data to drive insights and foresight increases, the ability to automate and analyze that data becomes a necessity. Accelerated digitalization in the healthcare space has revealed gaps in infrastructure, workforce, and digital education that ultimately need to be bridged.  


Real World Evidence SolutionsMarket Dynamics


Without intelligent analytics, RWE alone will not be able to produce meaningful and actionable results. Previously, the healthcare industry did not have the ability to gather RWE at the speed and scale needed to address urgent public health crises. However, this scenario has changed due to the pandemic. Advances in analytics and access to broad and diverse real-world data sets have made it possible to rapidly analyze data as it is captured to better understand how pandemics like COVID-19 are unfolding. 


The pre-approved use of RWE in efficacy decisions is being carried out currently, and there is potential for it to be used more broadly, such as in oncology, rare diseases, and pediatric conditions when randomized controlled clinical trials are impossible or unethical to conduct. In parallel, legislators are recognizing the value of RWE. In the US, the 21st Century Cures Act, passed in December 2016, has established public-private partnerships to collect data and improve the understanding of diseases. 

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