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

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.

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

Fingeraftryk

Phase II Clinical Trials
Public Opinion
Rheumatology
Sample Size
Control Groups

Citer dette

Pickles, T., Alten, R., Boers, M., Bykerk, V., Christensen, J., Christensen, R., ... Choy, E. H. (2019). Adaptive Trial Designs in Rheumatology: Report from the OMERACT Special Interest Group. Journal of Rheumatology, 46(10), 1406-1408. https://doi.org/10.3899/jrheum.181054
Pickles, Tim ; Alten, Rieke ; Boers, Maarten ; Bykerk, Vivian ; Christensen, Jared ; Christensen, Robin ; van Hoogstraten, Hubert ; Simon, Lee S ; Tam, Lai-Shan ; Choy, Ernest H. / Adaptive Trial Designs in Rheumatology : Report from the OMERACT Special Interest Group. I: Journal of Rheumatology. 2019 ; Bind 46, Nr. 10. s. 1406-1408.
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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.",
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Pickles, T, Alten, R, Boers, M, Bykerk, V, Christensen, J, Christensen, R, van Hoogstraten, H, Simon, LS, Tam, L-S & Choy, EH 2019, 'Adaptive Trial Designs in Rheumatology: Report from the OMERACT Special Interest Group', Journal of Rheumatology, bind 46, nr. 10, s. 1406-1408. https://doi.org/10.3899/jrheum.181054

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 tidsskriftTidsskriftartikelForskningpeer 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

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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.

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DO - 10.3899/jrheum.181054

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JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

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