Adaptive Trial Designs in Rheumatology: Report from the OMERACT Special Interest Group

Abstract

Objective.Adaptive trial design was developed initially for oncology to improve trial efficiency. If optimized for rheumatology, it may improve trial efficiency by reducing sample size and time.Methods.A systematic review assessed design of phase II clinical trials in rheumatoid arthritis.Results.Fifty-six trials were reviewed. Most trials had 4 groups (1 control and 3 intervention), with an average group size of 34 patients. American College of Rheumatology 20 measured at 16 weeks was the most commonly used primary endpoint.Conclusion.The next step is to undertake a systematic review of adaptive designs used in early-phase trials in nonrheumatic conditions.