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

被引：8

作者：

Pickles, Tim ^{[1
]}

Alten, Rieke ^{[2
]}

Boers, Maarten ^{[3
,4
,5
]}

Bykerk, Vivian ^{[6
,10
]}

Christensen, Jared ^{[7
]}

Christensen, Robin ^{[11
,12
]}

van Hoogstraten, Hubert ^{[8
]}

Simon, Lee S. ^{[9
]}

Tam, Lai-Shan ^{[13
,14
]}

Choy, Ernest H. ^{[1
]}

机构：

[1] Cardiff Univ, Div Infect & Immun, Rheumatol Sect, CREATE Ctr, Cardiff, S Glam, Wales

[2] Charite, Schlosspk Klin, Berlin, Germany

[3] Dept Epidemiol & Biostat, Amsterdam, Netherlands

[4] Amsterdam Rheumatol & Immunol Ctr, Amsterdam, Netherlands

[5] Univ Amsterdam, Med Ctr, VUmc, Amsterdam, Netherlands

[6] Hosp Special Surg, Weill Cornell Med Coll, Dept Rheumatol, 535 E 70th St, New York, NY 10021 USA

[7] Pfizer, New York, NY USA

[8] Sanofi, Bridgewater, MA USA

[9] SDG LLC, Cambridge, MA USA

[10] Univ Toronto, Mt Sinai Hosp, Rebecca McDonald Ctr Arthrit & Autoimmune Dis, Toronto, ON, Canada

[11] Bispebjerg & Frederiksberg Hosp, Parker Inst, Musculoskeletal Stat Unit, Odense, Denmark

[12] Odense Univ Hosp, Dept Rheumatol, Odense, Denmark

[13] Chinese Univ Hong Kong, Dept Med & Therapeut, Div Rheumatol, Hong Kong, Peoples R China

[14] Chinese Univ Hong Kong, Fac Med, Hong Kong, Peoples R China

来源：

JOURNAL OF RHEUMATOLOGY | 2019年 / 46卷 / 10期

关键词：

ADAPTIVE TRIAL DESIGN; OMERACT CORE OUTCOME SET; EARLY-PHASE CLINICAL TRIAL; RHEUMATOID ARTHRITIS; SYSTEMATIC REVIEW; CLINICAL-TRIALS;

D O I：

10.3899/jrheum.181054

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1406 / 1408

页数：3

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