Real world evidence studies: Perspective on study design and regulatory framework for RWE

There is a growing need for broader information on Real-World Effectiveness and safety of any new intervention, service or protocol vs data limited by standardized and strictly controlled environment like in a RCT. RWE studies gives the freedom for analysis based on a varied and diverse database. As Real-World Studies gain higher acceptance, it is important to understand the types of RWE studies and design that can be used. Data from real-world patient experience has the potential to improve the quality and delivery of medical care, impact overall costs and outcomes. This review helps understand study designs, issues, and its implications in improving medical services. Though the RWE is challenged by diversity of information, large data sets of uncertain quality, and methodological rigor, however if utilized properly has potential to shape policies, protocols and develop programs to implement best practices.RWE has many issues including Legal, technological, data privacy, transparency, and standardization. These challenges can be and necessarily need to be addressed while planning the RWE which would then vastly enhance the acceptance of the evidence generated by RWE. Several researchers, professional societies, government agencies and multi-stakeholder initiatives  worldwide have disseminated guidance, framework, and standards in this aspect which can address gaps in data standardization and improve the quality of RWD