The design of clinical trials aimed at assessing the DC-ART properties of new molecules in rheumatoid arthritis.
Considerations in designing clinical trials of novel molecules are not different from those that should be considered in every rheumatoid arthritis clinical trial. This article raises some critical issues that clinicians have to face in the planning and design of clinical trials for new molecules in rheumatoid arthritis. The most frequent problems are related to outcome measures (core set of endpoints, improvement and remission), patient populations, characteristics of the study design, and economic evaluation. Although some of these issues have been resolved by consensus, further research needs to be carried out to support the use of different measurement techniques. Because clinical trials remain the most powerful investigative instrument for deciding about the benefits of new advances in medical therapy, their design should be based on an appropriate methodology.
Ortiz
Z
Z
Instituto Municipal de Rehabilitación Psico-fisica, Buenos Aires, Argentina.
Tugwell
P
P
Yocum
D
D
D018501:Antirheumatic Agents / Q000145:classification / Q000191:economics / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002986:Clinical Trials as Topic / Q000592:standards*; D004185:Disability Evaluation; D006801:Humans; D011788:Quality of Life; D012107:Research Design / Q000592:standards*; D016896:Treatment Outcome
D018501:Antirheumatic Agents