Adaptive Trial Designs in Rheumatology: Report from the OMERACT Special Interest Group
Publication in refereed journal
Officially Accepted for Publication


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AbstractObjective
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.
Acceptance Date18/12/2018
All Author(s) ListTim Pickles, Rieke Alten, Maarten Boers, Vivian Bykerk, Jared Christensen, Robin Christensen, Hubert van Hoogstraten, Lee S. Simon, Lai-Shan Tam and Ernest H. Choy
Journal nameJournal of Rheumatology
Year2019
ISSN0315-162X
eISSN1499-2752
LanguagesEnglish-United Kingdom
KeywordsADAPTIVE TRIAL DESIGN, OMERACT CORE OUTCOME SET, EARLY-PHASE CLINICAL TRIAL, RHEUMATOID ARTHRITIS, SYSTEMATIC REVIEW

Last updated on 2021-16-10 at 00:37