Challenges often arise in medical device evaluations with a traditional clinical trial due to practical issues given the nature of the device or ethical concerns. In such cases, when the real world data (RWD) contains sufficiently relevant and reliable information, it may be used to reduce time in FDA decision-making and bring the drug or device faster to the public. Furthermore, RWD may be used to leverage the real-world drug/device use and performance in a wider intended use population than the information collected through a traditional clinical trial. These traditional clinical trials well control factors to potentially limit bias on the device performance.
Recently issued FDA draft guidance on real world evidence (RWE) described situations where it can be used for premarket approval, types of RWD that can be utilized, limitations for use of RWD, and elements such as the relevance and reliability of RWD. They also provided few examples where RWE can be used in therapeutic devices. However, there were limited guideline on where and how RWD can be used for diagnostic devices, and it is also not clear on what type of data can be considered as RWD for diagnostic devices. In addition, recently published paper in New England Journal on RWE focuses heavily on registry data which are also more relevant to therapeutic devices and provides limited guidelines for diagnostic devices.
In this FDA Townhall Roundtable, we will have a casual discussion with representatives from academia, industry, and FDA to provide clarifications on use of RWE and types of RWD. We will also openly communicate the expectations and potential challenges of using RWE and RWD for premarket approval or clearance. Tentative list of Panel Discussants: • Meijuan Li, PhD, Chief, Diagnostic Statistics Branch II, Division of Biostatistics, OSB, CDRH, FDA • Tom Gwise, PhD, Deputy Director, Division of Biostatistics V, OB, OTS, CDER, FDA • Telba Irony, PhD, Deputy Director, Office of Biostatistics and Epidemiology, CBER, FDA • Gerry Gray, PhD, DATA-fi • Myung Kim, PhD, Executive Director, Epidemiology, Medical Devices, Johnson & Johnson Co.