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Adaptive trial designs in rheumatology: Report from the OMERACT Special Interest Group

Pickles, Tim, Alten, Rieke, Boers, Maarten, Bykerk, Vivian, Christensen, Jared, Christensen, Robin, van Hoogstraten, Hubert, Simon, Lee S., Tam, Lai-Shan and Choy, Ernest H. 2019. Adaptive trial designs in rheumatology: Report from the OMERACT Special Interest Group. Journal of Rheumatology , jrheum.181054. 10.3899/jrheum.181054
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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.

Item Type: Article
Date Type: Published Online
Status: In Press
Schools: Medicine
Centre for Trials Research (CNTRR)
Publisher: Journal of Rheumatology
ISSN: 0315-162X
Date of First Compliant Deposit: 25 February 2019
Date of Acceptance: 18 December 2018
Last Modified: 03 Sep 2019 14:38
URI: http://orca-mwe.cf.ac.uk/id/eprint/119832

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