OARSI FDA OA Initiative
In October of 2007, the Osteoarthritis Research Society International (OARSI) submitted a proposal to the Food and Drug Administration (FDA) in response to their request to receive additional information on issues related to clinical development programs for drugs, biological products, and medical devices for the treatment and prevention of osteoarthritis (OA). Specifically, a request was made to conduct and manage the coordination of a critical appraisal of the science related to the design of clinical development programs for the treatment and prevention of OA to assist the agency as they work to finalize the OA draft guidance originally issued in July 1999. The FDA accepted OARSI’s proposal and work began in June of 2008 under the guidance of an Executive Committee whose members include Drs. Steven Abramson, Francis Berenbaum, Marc Hochberg, and Roland Moskowitz, and the expert advice of Dr. Lee Simon, former Director of the Division of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products, U.S. Food and Drug Administration. Eight Working Groups were created to address specific areas outlined within the FDA’s original federal register notice:
Individuals representing academia, industry, patient organizations and government agencies actively participate in the Working Groups.
The project deliverables include the following:
The first public meeting took place in December 2008 and was attended by 80 individuals, including representatives from academia, patient organizations, government agencies, and pharmaceutical and device companies. Each Working Group Chair provided an update of their current work plan and suggested research agenda. The work plans were vetted and discussed for their practicality and applicability. Informed by the meeting discussions, the plans were updated and work has continued during 2009. The Executive Committee has approved two research agendas. The first was submitted by the Claim of Symptomatic Relief Working Group and is focused on establishing a comprehensive database of randomized, blinded, OA clinical trials where the validity and responsiveness of primary and secondary outcome measures used in OA trials will be examined. The Assessment of Structural Change Working Group submitted the second research agenda and is currently conducting a systematic literature review focusing on the psychometrics of validity, reliability, and sensitivity to change of conventional radiographic measurement of interbone distance (joint space narrowing), and magnetic resonance imaging (cartilage thickness, morphology, volume, compositional measures, bone marrow lesions, bone attrition, menisci, synovitis).
The Biomarkers Working Group conducted a webinar that included a faculty of experts in biomarker qualification, including Federico Goodsaid, PhD, Associate Director for Operations in Genomics within the FDA’s Center for Drug Evaluation and Research.
A Pre-Congress Workshop is planned during the 2009 OARSI World Congress that will provide all attendees with an update on the OARSI FDA Initiative and will include presentations by many of the Working Group Chairs.
The second and final public meeting is scheduled for December 15, 2009 in Washington, D.C. at which time the recommendations for the updating of the 1999 OA Draft Guidance will be discussed and finalized.
The OARSI FDA OA Initiative gratefully acknowledges financial support from:
The American College of Rheumatology, Astra Zeneca, Alpharma, Amgen, ArthroVision/ArthroLab,
Chondrometrics, Cypress BioScience, CombinatorRx, Expanscience, 4QImaging, Genzyme, Merck, Merck Serono, Novartis. NicOx, Pfizer, Rottapharm, Smith & Nephew, Wyeth, Depuy Mitek.