RECOMMENDATIONS FOR A CORE SET OF OUTCOME MEASURES FOR FUTURE PHASE-III CLINICAL-TRIALS IN KNEE, HIP, AND HAND OSTEOARTHRITIS - CONSENSUS DEVELOPMENT AT OMERACT-III

Significant progress has been made in outcome measurement procedures f or osteoarthritis (OA)clinical trials, and guidelines have been establ ished by the US Food and Drug Administration, European League Against Rheumatism, the World Health Organization/International League of Asso ciations for Rheumatology, and the Group for the Respect of Ethics and Excellence in Science. However, there remains a need for further inte rnational harmonization of measurement procedures used to establish be neficial effects in Phase III clinical trials. A key objective of the OMERACT III conference was to establish a core set of outcome measures for future phase III clinical trials. During the conference, using a combination of discussion and polling procedures, a consensus was reac hed by at least 90% of participants that the following 4 domains shoul d be evaluated in future phase III trials of knee, hip, and hand OA: p ain, physical function, patient global assessment, and, for studies of one year or longer, joint imaging (using standardized methods for tak ing and rating radiographs, or any demonstrably superior imaging techn ique). These evidence based preferences, achieved with a high degree o f consensus, establish an international standard for future phase III trials and will also facilitate metaanalysis and Cochrane Collaborativ e Project goals.