Insights in Biomedicine Open Access

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Abstract

Evidence-Based Studies - Their Advantages and Disadvantages in the Data Collection Ecosystem

Barick Uttam, Vijay Kanth Anto, Gowda Arun, Mohanty Rituraj and Zomorodi Behsad

Real World Evidence (RWE) is an ideal tool to perform a proof of concept that a pharmaceutical company deems necessary to demonstrate the real scenario of healthcare in practice. Real-world studies define the market landscape, economic and patient burden of illness, and prevailing treatment modes prior to the launch of a particular drug. There is an ever-increasing connectivity between RWE and digital healthcare. The integration of Electronic Health Records (EHR) has been the driving force behind several innovations in RWE. The evolution of ‘eHealth’ covers a wide range of e-Health apparatuses like e-prescriptions, tele-health and patients’ electronic health records (EHRs), which are becoming an integral part of RWE. In spite of the challenges in establishing the best practices in RWE programs, real world evidence has the potential to both escalate adeptness in research and development and to bridge the gap between the proof of appropriateness required to pass regulatory scrutiny and the demonstration of likely effectiveness needed to cater to the needs of health technology assessment bodies.