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

Tim Pickles, Rieke Alten, Maarten Boers, Vivian Bykerk, Jared Christensen, Robin Christensen, Hubert van Hoogstraten, Lee S Simon, Lai-Shan Tam, Ernest H Choy

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

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.

OriginalsprogEngelsk
TidsskriftJournal of Rheumatology
Vol/bind46
Udgave nummer10
Sider (fra-til)1406-1408
ISSN0315-162X
DOI
StatusUdgivet - okt. 2019

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