Real-world data (RWD) and real-world evidence (RWE) are playing increasing roles in health care decisions. The FDA is using RWD and RWE to track postmarket safety and adverse events and, to an ever-increasing extent, using both to make regulatory decisions, including premarket decisions about the safety and effectiveness of FDA-regulated products.

In addition, medical product developers are increasingly using RWD and RWE as they design clinical trials and observational studies for new drugs, medical devices and biological products.

This white paper from Thompson FDA:

• Outlines the FDA’s current thinking about the use of RWE and RWD in clinical trials and in the agency’s regulatory decision-making
• Explores the range of issues that the FDA is considering as it evaluates the potential of RWD and RWE for clinical trials and the agency’s product reviews
• Surveys agency guidance documents and policy statements that can help medical product sponsors and clinical research professionals understand the potential of RWE and RWD — as well as the agency’s compliance expectations concerning their use
• And more!