Pickles, Tim ORCID: https://orcid.org/0000-0001-7743-0234, Alten, Rieke, Boers, Maarten, Bykerk, Vivian, Christensen, Jared, Christensen, Robin, van Hoogstraten, Hubert, Simon, Lee S., Tam, Lai-Shan and Choy, Ernest H. ORCID: https://orcid.org/0000-0003-4459-8609 2019. Adaptive trial designs in rheumatology: Report from the OMERACT Special Interest Group. Journal of Rheumatology 46 (10) , pp. 1406-1408. 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 |
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Date Type: | Publication |
Status: | Published |
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: | 06 Nov 2023 21:07 |
URI: | https://orca.cardiff.ac.uk/id/eprint/119832 |
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