FDA has created a Real World Evidence Program framework for evaluating the potential use of real-world evidence (RWE) to help

• support the approval of a new indication for a drug already approved under section 505(c) of the FD&C Act
• support or satisfy drug post approval study requirements
• Support drug and biological products approved under section 505(c)

FDA has also defined

• Real-World Data (RWD) are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
• RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD
• Observational studies are non-interventional clinical study designs that are not considered clinical trials. Includes Retrospective and Prospective Definitions in context with data availability from the start of study (time point when research protocol is initiated).

It has been observed that budget for RWE studies is relatively lesser as compared to clinical trials. However, there is a trend to utilize large patient population in multi-year, multiple data source based prospective RWE (Observational Studies). As, industry outsources observational studies, industry has a minimal view of the emerging risks in study conduct phase. FDA plans to examine the use of risk-based and central monitoring for clinical trials that are integrated into the health care system. There is a strong need for adopting principles of Risk Based and centralized monitoring to proactively identify risks related to patient enrolment, data, site and compliance risks across the RWE study cycle and mitigate to ensure compliance, study design and budget effectiveness. As RWE studies, include complexities involving variable patterns of treatment, heterogeneous study groups, multiple investigators and disparate data sources, it becomes imperative to monitor RWE studies in Real Time.