Design and conduct of clinical trials in osteoarthritis.
Clinical features of osteoarthritis (OA) require that general recommendations for the design and conduct of clinical trials be modified in order to apply these concepts to clinical trials in OA. A format has been devised for design of clinical trials in OA. In order to assess the applicability of this format, it has been compared to a published clinical trial: chondroprotective agents versus standard treatment of OA of the knee. The published study appeared reliably designed and conducted in a manner that provided an answer to most of the questions posed. The study appears to form a sound basis for additional studies.
Altman
R D
RD
Division of Rheumatology, School of Medicine, University of Miami, Florida 33101.
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006025:Glycosaminoglycans / Q000627:therapeutic use; D006801:Humans; D010003:Osteoarthritis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D014020:Tissue Extracts / Q000627:therapeutic use
D000894:Anti-Inflammatory Agents, Non-Steroidal; D006025:Glycosaminoglycans; D014020:Tissue Extracts; C000562:Rumalon; C010034:Arteparon