Design and conduct of clinical trials in patients with osteoarthritis of the hand: recommendations from a task force of the Osteoarthritis Research Society International

A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee1. Limited material available on clinical trials of OA of the hand2-4 has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to hand OA. The Task Force was composed of academic physicians, clinical physicians and researchers in the pharmaceutical industry. Task Force expenses were supported by unrestricted grants provided by pharmaceutical company representatives (see the Acknowledgments section). The Task Force elected to produce a set of guidelines that are based on the published medical literature supplemented by expert opinion. Small working groups dealt with specific aspects of trial design. The Task Force met in whole, or in part, on four occasions over a 4-year period between 2001 and 2005. Additional modifications of the guidelines were made through e-mail correspondence. The Board of Directors of the OARSI requested further refinement of the guidelines document and established a set of workshops at the OARSI World Congress on Osteoarthritis held in Chicago, in December 2004. Subsequent e-mail correspondence was required to address outstanding issues, and the final guidelines were submitted to Osteoarthritis and Cartilage for independent external review, and to the OARSI Board of Directors for approval, prior to publication. As research methods for clinical trials in OA of the hand have not been as well developed as those for knee and hip OA2-4, it is anticipated that the methodology for performing clinical trials of drugs for hand OA will evolve as more is learned. It should therefore be understood that the following recommendations will need to be modified as new information becomes available. Investigators, and representatives of regulatory and sponsoring agencies, need to be aware of the need for such changes; and new methodologies will need to be incorporated into the protocol design. The Task Force is of the opinion that changes in protocol design should be based on published data. The Task Force recommends that developers of new protocols should utilize credible and validated measures where available, for primary outcome assessments and should consider including, instruments and measurement techniques requiring initial or additional validation as additional secondary outcome measures. The guidelines are recommendations, not rigid rules, for the conduct of clinical trials in OA of the hand. Many of the recommendations are supported by published clinical research. However, some recommendations have yet to be validated and are suggestions based on the best judgment and expert opinion of the Task Force at the time the guidelines were finalized. These guidelines have been constructed to build upon, and follow the pattern of, previously published guidelines1. © 2006 OsteoArthritis Research Society International.