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

Research output: Contribution to journalJournal articleResearchpeer-review

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.

Original languageEnglish
JournalJournal of Rheumatology
Volume46
Issue number10
Pages (from-to)1406-1408
ISSN0315-162X
DOIs
Publication statusPublished - Oct 2019

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Phase II Clinical Trials
Public Opinion
Rheumatology
Sample Size
Control Groups

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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. In: Journal of Rheumatology. 2019 ; Vol. 46, No. 10. pp. 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, vol. 46, no. 10, pp. 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.

In: Journal of Rheumatology, Vol. 46, No. 10, 10.2019, p. 1406-1408.

Research output: Contribution to journalJournal articleResearchpeer-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

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VL - 46

SP - 1406

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JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

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