FDA Issues Draft Guidance on Real-World Data

In September, FDA issued a draft guidance to clarify how it evaluates real-world data to determine whether it can be used in FDA regulatory decision-making for medical devices. The guidance explains how FDA will use data collected outside of traditional clinical trials, such as electronic health records and registries, as a part of the medical device process. This data, as the guidance explains, is only appropriate if it represents the population being studied.
Introduction to Real-World Data (RWD) and Real-World Evidence (RWE)
The guidance outlines the FDA’s definition of these terms, considering real-world data (RWD) to include that that is collected from sources outside of traditional clinical trials. These sources may include large simple trials, or pragmatic clinical trials, prospective observational or registry studies, retrospective database studies, case reports, administrative and healthcare claims, electronic health records, data obtained as part of a public health investigation or routine public health surveillance, and registries (e.g., device, procedural, or disease registries). The data is typically derived from electronic systems used in health care delivery, data contained within medical devices, and/or in tracking patient experience during care, including in home-use settings. Furthermore, real-world evidence (RWE) to be evidence that is derived from the aggregation and analysis of RWD elements.
FDA explains that routine clinical practice often involves ...

Source: Policy and Medicine - October 10, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs