Resumé
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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Journal of Rheumatology |
| Vol/bind | 46 |
| Udgave nummer | 10 |
| Sider (fra-til) | 1406-1408 |
| ISSN | 0315-162X |
| DOI | |
| Status | Udgivet - okt. 2019 |
Fingeraftryk
Citer dette
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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; Choy, Ernest H.
I: Journal of Rheumatology, Bind 46, Nr. 10, 10.2019, s. 1406-1408.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review
TY - JOUR
T1 - Adaptive Trial Designs in Rheumatology
T2 - Report from the OMERACT Special Interest Group
AU - Pickles, Tim
AU - Alten, Rieke
AU - Boers, Maarten
AU - Bykerk, Vivian
AU - Christensen, Jared
AU - Christensen, Robin
AU - van Hoogstraten, Hubert
AU - Simon, Lee S
AU - Tam, Lai-Shan
AU - Choy, Ernest H
PY - 2019/10
Y1 - 2019/10
N2 - 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.
AB - 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.
U2 - 10.3899/jrheum.181054
DO - 10.3899/jrheum.181054
M3 - Journal article
VL - 46
SP - 1406
EP - 1408
JO - Journal of Rheumatology
JF - Journal of Rheumatology
SN - 0315-162X
IS - 10
ER -