EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis
EULAR recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis: focus on anti-neutrophil cytoplasm antibody-associated vasculitis
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DOI：
10.1136/ard.2006.062711
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发表时间：
2007-05-01
影响因子：
27.4
通讯作者：
Luqmani, Raashid A.
中科院分区：
文献类型：
--
作者：
Hellmich, Bernhard;Flossmann, Oliver;Luqmani, Raashid A.
目的：制定欧洲抗风湿病联盟（EULAR）关于系统性血管炎临床研究和/或临床试验的建议。方法：成立了一个专家共识小组，由代表五个欧洲国家和美国的风湿病学家、肾脏病学家和内科专家、一名临床流行病学家和来自监管机构的代表组成。该小组采用基于证据和专家意见的方法，根据标准化的 EULAR 操作程序，通过修改后的德尔菲技术确定了系统文献检索的九个主题。根据专家组提出的研究问题，提出了针对系统性血管炎开展临床研究和/或临床试验的建议。 结果：根据文献研究的结果，专家委员会得出的结论是，仅针对抗中性粒细胞胞浆抗体相关性血管炎（AAV）有足够的证据来制定临床试验指南。因此决定将建议重点放在这些疾病上。本摘要文件详细阐述并提出了进行 AAV 临床试验的建议。决定考虑血管炎的具体问题而不是试验方法的一般问题。这些建议涉及与血管炎临床研究相关的以下领域：疾病的定义、活动状态、结果测量、资格标准、试验设计（包括相关终点）和生物标志物。试验方法的许多方面被认为对未来的研究很重要。结论：根据专家意见，制定了进行 AAV 临床试验的建议。此外，专家委员会还发现，非常需要针对非 AAV 系统性血管炎进行精心设计的研究。
Objectives: To develop the European League Against Rheumatism (EULAR) recommendations for conducting clinical studies and/or clinical trials in systemic vasculitis.Methods: An expert consensus group was formed consisting of rheumatologists, nephrologists and specialists in internal medicine representing five European countries and the USA, a clinical epidemiologist and representatives from regulatory agencies. Using an evidence-based and expert opinion-based approach in accordance with the standardised EULAR operating procedures, the group identified nine topics for a systematic literature search through a modified Delphi technique. On the basis of research questions posed by the group, recommendations were derived for conducting clinical studies and/or clinical trials in systemic vasculitis.Results: Based on the results of the literature research, the expert committee concluded that sufficient evidence to formulate guidelines on conducting clinical trials was available only for anti-neutrophil cytoplasm antibody-associated vasculitides (AAV). It was therefore decided to focus the recommendations on these diseases. Recommendations for conducting clinical trials in AAV were elaborated and are presented in this summary document. It was decided to consider vasculitis-specific issues rather than general issues of trial methodology. The recommendations deal with the following areas related to clinical studies of vasculitis: definitions of disease, activity states, outcome measures, eligibility criteria, trial design including relevant end points, and biomarkers. A number of aspects of trial methodology were deemed important for future research.Conclusions: On the basis of expert opinion, recommendations for conducting clinical trials in AAV were formulated. Furthermore, the expert committee identified a strong need for well-designed research in non-AAV systemic vasculitides.