DIA 2017 Annual Meeting

Real World Evidence (RWE) has emerged as an area of great interest and opportunity, especially with ever-increasing capabilities for data mining. RWE has established value in informing prescriber and payer decision-making and interest in RWE generation and use continues to grow with discussions turning to possibilities of its value in supporting new indications and label claims. While broadly the quality objectives of “human research subject protection/patient safety” and “data reliability” apply to RWE, there is no definitive quality regulation or even guidance for the research that generates RWE as there is for interventional, well-controlled clinical trials. In this discussion, we will explore the expectations for quality and compliance in the rapidly expanding RWE ecosystem and how they can be achieved using pragmatic – and perhaps even unconventional – approaches.