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 Item availability restricted.

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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:	29 Jun 2019 15:53
URI:	http://orca.cf.ac.uk/id/eprint/119832

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