News from the healthcare data industry
When Robert Califf became the new commissioner of the U.S. Food & Drug Administration, he did so with a plan to emphasize the use of real-world evidence (RWE) in Agency decisions....
Background To assess the performance of various coding algorithms for identifying people with hepatitis B virus (HBV) and hepatitis C virus (HCV) using claims data according to different reference standards...
SAN FRANCISCO, March 3, 2022 /PRNewswire/ — NephroSant™ a biotechnology company dedicated to accelerating the diagnosis of early kidney damage in native and transplanted kidneys, with a mission to significantly improve global kidney...
Posted 02 March 2022 | By Mary Ellen Schneider Pharmaceutical manufacturers and patient advocates want to see more details from the US Food and Drug Administration as it finalizes guidance on...
Abstract Real-world data (RWD) and real-world evidence (RWE) are becoming essential tools for informing regulatory decision making in health care and offer an opportunity for all stakeholders in the health...
In this article, Peter Persson and Ben Tichler (both Biogen) discuss the role of real-world evidence in rare diseases, specifically spinal muscular atrophy, and how real-world data can be used...
Accessing compelling and relevant evidence is crucial to drug development, safety monitoring, and improved patient outcomes. However, gaps between clinical trial data (CTD) and real world data (RWD) make it...
Zachary BrennanSenior EditorThe clinical trial ecosystem in North America was upended quickly by Covid-19, casting a giant spotlight on inefficiencies and the need to make room for more decentralized clinical...
National Coordinator for Health IT Micky Tripathi points to information blocking, API standardization and TEFCA as key factors in enhancing critical interoperability. By Kat Jercich February 22, 202204:21 PM Photo:...
Executive Summary In comments on FDA guidance on electronic health records and medical claims, Duke-Margolis Center suggests a certification process for validated datasets, while data companies request the agency do...