Global Real-World Evidence (RWE) Solutions Market estimated at close to $1 billion (2020), is growing at a steady growth rate of 15%
RWE is the clinical evidence regarding usage and potential benefits/risks of a medical product based on analysis of the real-world data. RWE to play vital role in helping regulators formulating decisions RWE could potentially help FDA while making regulatory decisions about the safety and effectiveness of medical products such as identifying new safety issues post-approval or determine the effectiveness of a drug for a new indication or patient population. Citing the potential, the 21st Century Cures Act (Cures Act, signed in 2016) required FDA to publish a framework for a program to evaluate the use of RWE in regulatory decision-making; FDA published the framework for this program in December 2018. As part of its RWE Program, FDA committed to understanding the full potential of RWD and RWE in regulatory decision-making. The agency has been holding workshops, funding demonstration projects, creating mobile and web applications that can collect RWD, and engaging with spo...