The Pre-Competitive Consortium for Osteoarthritis, an initiative of the Osteoarthritis Research Society International, submitted a White Paper entitled Osteoarthritis as a Serious Disease to the U.S. Food and Drug Administration on December 1, 2016.
The Pre-Competitive Consortium for Osteoarthritis (PCCOA) mission is to advance the development of structure modifying therapies for the treatment of patients with OA. The strategy of the PCCOA is to enhance collaboration among stakeholders and promote the sharing of knowledge of barriers and opportunities for OA drug discovery and development. The ultimate goal is to synthesize the expertise of academic researchers, clinical investigators, and representatives from pharmaceutical and biotechnology R&D segments to effectively inform the drug approval process about ways to remove the current barriers to new treatments for OA.
The development of the White Paper required an extensive review of the epidemiology of OA, impact on quality of life, associated symptoms and functional disability, and association with increased risk of comorbidity and mortality. An additional systematic review of clinically relevant outcomes in OA was undertaken to establish the argument that biomarkers (biochemical and/or imaging) used as intermediate endpoints can serve as surrogates of structural change and that the measured changes are meaningful as they relate to the clinical outcomes of pain and stiffness, need for assistive devices or need for joint replacement.
Lastly, but most importantly, the PCCOA will be moving forward to collaborate with patients to gain their perspectives, which will further inform the strategic messaging to be delivered to governmental agencies within the US and Europe.