Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials: Need for Minimum Reporting Requirements

Stamp Lisa K.; Morillon Melanie B.; Taylor William J.; Dalbeth Nicola; Singh Jasvinder A.; Lassere Marissa; Christensen Robin

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Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials: Need for Minimum Reporting Requirements

机译：血清呼吸术和呼出临床试验中的血清呼吸和耀斑的变异性：需要最低报告要求

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摘要

Objective. To describe the ways in which serum urate (SU) and gout flares are reported in clinical trials, and to propose minimum reporting requirements.

机译：客观的。描述临床试验中报告血清尿酸盐（SU）和痛风耀斑的方式，并提出最低报告要求。

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来源
《The Journal of rheumatology》 |2018年第3期|共6页
作者
Stamp Lisa K.; Morillon Melanie B.; Taylor William J.; Dalbeth Nicola; Singh Jasvinder A.; Lassere Marissa; Christensen Robin;
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作者单位

Univ Otago Dept Med POB 4345 Christchurch New Zealand;

Parker Inst Bispebjerg &

Frederiksberg Hosp Musculoskeletal Stat Unit Dept Rheumatol Odense Univ;

Univ Otago Dept Med POB 4345 Christchurch New Zealand;

Univ Auckland Dept Med Auckland New Zealand;

Univ Alabama Birmingham Dept Med Birmingham AL 35294 USA;

Univ New South Wales NSW Dept Rheumatol St George Hosp Sydney NSW Australia;

Bispebjerg &

Frederiksberg Hosp Musculoskeletal Stat Unit Parker Inst Birmingham AL USA;

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原文格式 PDF
正文语种 eng
中图分类免疫性疾病;
关键词
GOUT; SERUM URATE; OUTCOME MEASURES; GOUT FLARES;

机译：痛风;血清呼吸;结果措施;痛风耀斑;

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专利

1. Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials: Need for Minimum Reporting Requirements [J] . Stamp Lisa K., Morillon Melanie B., Taylor William J., The Journal of rheumatology . 2018,第3期

机译：血清呼吸术和呼出临床试验中的血清呼吸和耀斑的变异性：需要最低报告要求
2. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States [J] . Ina Jazic, Olivia M Shopshear, Jocelyn Ulrich, BMJ Open . 2017,第9期

机译：临床试验透明度：重新评估行业对美国临床试验注册和报告要求的遵守情况
3. Safety reporting in clinical trials: new regulatory requirements arising by the regulation (EU) No 536/2014 of the European parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use [J] . Duranton S., Autexier M. D., Carlhant-Kowalski D., Fundamental & clinical pharmacology. . 2016,第Suppla1期

机译：临床试验中的安全报告：法规（欧盟）产生的新监管要求（欧盟）欧洲议会的第536/2014号和2014年4月16日的理事会关于人类使用的药品临床试验
4. High variability in Summative Usability Test methods reporting among clinical informatics vendors complying with Federal certification requirements [C] . Christine Buchanan, Anthony Threatt, Matthew B. Weinger, Human Factors and Ergonomics Society;Human Factors and Ergonomics Society annual meeting . 2014

机译：符合联邦认证要求的临床信息学供应商之间的汇总可用性测试方法和报告差异很大
5. Hypersensitivity Adverse Event Reporting in Clinical Cancer Trials: Barriers and Potential Solutions to Studying Severe Events on a Population Level [D] . ?Eldredge, Christina 2020

机译：临床癌症试验中的超敏反不良事件报告：障碍和潜在的解决方案，用于研究人口水平的严重事件
6. The challenges of gout flare reporting: mapping flares during a randomized controlled trial [O] . Novell Teoh, Gregory D. Gamble, Anne Horne, 2019

机译：痛风火炬报告的挑战：在随机对照试验中测绘火炬
7. OP0267 Serum urate as a surrogate endpoint for gout flares: results of a systematic review and meta-regression analysis of randomized trials [O] . L Stamp, M Morillon, W Taylor, 2017

机译：OP0267血清呼吁作为痛风斑点的代理终点：随机试验的系统评价和元回归分析的结果
8. Clinical Nutritional Study of Minimum Protein and Caloric Requirements for Man Annual Report, Sep. 1964 - Sep. 1965 [R] . Calloway, D. H., Margen, S. 1966

机译：1964年9月 - 1965年9月男性年度报告最低蛋白质和热量需求的临床营养研究

Variability in the Reporting of Serum Urate and Flares in Gout Clinical Trials: Need for Minimum Reporting Requirements

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