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Summary and recommendations of the OARSI FDA osteoarthritis Assessment of Structural Change Working Group
2011
Import JabRef | WosArea Orthopedics; Rheumatology; International audience; Objective: The Osteoarthritis Research Society International initiated a number of working groups to address a call from the US Food and Drug Administration (FDA) on updating draft guidance on conduct of osteoarthritis (OA) clinical trials. The development of disease-modifying osteoarthritis drugs (DMOADs) remains challenging. The Assessment of Structural Change (ASC) Working Group aimed to provide a state-of-the-art critical update on imaging tools for OA clinical trials. Methods: The Group focussed on the performance metrics of conventional radiographs (CR) and magnetic resonance imaging (MRI), performing systemati…