Wednesday, December 23, 2020
In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug Administration (FDA) has continued to make substantial progress on its non-COVID priorities as well.
Continued Progress on Non-COVID Priorities…
Besides the obvious scientific, technical, and regulatory work that FDA and other stakeholders have been doing all year to mount a comprehensive response to the emergence of SARS-CoV-2 as a pandemic pathogen, the agency’s work on other high-priority human drug and biological product regulatory programs continued during 2020. FDA has demonstrated a fairly impressive ability to manage a huge number of competing priorities, even as certain areas like pre-approval inspections and re-inspections of facilities seeking removal from an import alert have suffered in the face of travel restrict
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NEW YORK, Dec. 17, 2020 /PRNewswire/ Real-world evidence (RWE) studies can offer comparable insights to randomized controlled trials (RCTs), particularly when the intent is to compare clinically meaningful treatment scenarios using rigorous study design and fit-for-purpose data, according to results from the RCT-DUPLICATE project published today in
Circulation. Researchers from Brigham and Women s Hospital (BWH) and Harvard Medical School, in close collaboration with the U.S. Food and Drug Administration (FDA) and Aetion, reported the findings from 10 RWE studies designed to emulate RCTs for cardiovascular outcomes of antidiabetic or antiplatelet medications.
Nine of the 10 RWE studies achieved at least two of three agreement metrics that researchers set at the outset. For each of these nine studies, the difference in results between the RWE and RCT was not statistically significant. Eight of the nine RWE findings achieved estimate agre