This is the audio-only version of DEVICE LOVE Live! #23, originally recorded 19 November 2020.

As defined by the FDA, Real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, like electronic health records and product and disease registries. With the additional requirements of the EU MDR, RWD can also be gathered from PMCF studies and surveys, and EUDAMED. Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and observational studies (prospective and/or retrospective).

More simply put, RWD are the data sources obtained outside of a traditional clinical trial, which are then analyzed to generate RWE or used to define a study to create RWE.  RWE can provide a faster and more efficient method to meet the evidentiary requirements for FDA and EU regulatory submissions, but it is not without its challenges.

Determining what RWD and RWE are and how to apply them for your device can be daunting.  In this show, we will simplify these terms and discuss best practices.  We'll also answer the questions we often receive including the following:

Bring your toughest RWD/RWE questions for our experts to answer LIVE!