OARSI Report to the FDA - July, 2010
In October 2007, the Osteoarthritis Research Society International (OARSI) responded to an RFP from the FDA to conduct and manage the coordination of a critical appraisal of certain fundamentals of the science related to the design of clinical development programs for human drugs, biological products, and medical devices for the treatment and prevention of osteoarthritis to assist the agency as they work to finalize the draft guidance originally issued in July 1999.
OARSI received notification that their proposal had been accepted and subsequently embarked upon a two-year initiative to address the key issues as outlined within the original RFP.
The report reviews the work undertaken by seven working groups to address the key areas identified within the RFP. Recommendations have been provided based on the most recent data available. Additionally, recommendations for subsequent research agendas required to address areas where data is not yet available to support a specific recommendation have also been outlined. The reports from the individual working groups have been published in Osteoarthritis and Cartilage, Volume 19, Issue 5 , Pages 475-610 (May 2011)