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您关心哪些主题可以使狼疮试验更有效?国际狼疮专家开放空间会议的结果。

What are the topics you care about making trials in lupus more effective? Results of an Open Space meeting of international lupus experts.

机构信息

Policlinic and Hiller Research Unit, Heinrich Heine University Düsseldorf, Dusseldorf, Nordrhein-Westfalen, Germany

GENYO, Centre for Genomics and Oncological Research, Pfizer/University of Granada/Andalusian Regional Government, Granada, Spain.

出版信息

Lupus Sci Med. 2021 May;8(1). doi: 10.1136/lupus-2021-000506.

Abstract

Despite promising candidates for new therapeutic options in the treatment of systemic lupus erythematosus (SLE), many clinical trials have failed in the past few years. The disappointing results have been at least partly be attributed to trial designs. With the aim of stimulating new developments in SLE trial design, an international open space meeting was held on occasion of the European Lupus Meeting 2018 in Duesseldorf, Germany about 'What are the topics you care about for making trials in lupus more effective?'. The Open Space is a participant-driven technology, where the discussion topics and schedule are selected during the meeting by all participants and discussion rounds are led by the people attending encouraging active contributions. Eleven topics were selected for further discussion, of which 6 were voted to be more intensively discussed in two consecutive rounds. Major topics were the optimal handling of glucocorticoids in clinical trials, the improvement of outcome measures, reducing or controlling the placebo response and the identification of biomarkers and stratification parameters. Further, the importance of local and international networks was emphasised. By networking, collaborations are facilitated, patient recruitment is more efficient and treatment can be harmonised thus lead to more successful SLE trials. Further discussions are needed to substantiate the results and develop new trial designs.

摘要

尽管在治疗系统性红斑狼疮(SLE)方面有很有前途的新治疗选择的候选者,但在过去几年中,许多临床试验都失败了。令人失望的结果至少部分归因于试验设计。为了激发 SLE 试验设计的新发展,在德国杜塞尔多夫举行的 2018 年欧洲狼疮会议期间,举行了一次国际开放式空间会议,主题是“对于使狼疮试验更有效,您关心哪些主题?”开放式空间是一种由参与者驱动的技术,其中讨论主题和时间表由所有参与者在会议期间选择,讨论轮由参加的人主持,鼓励积极参与。选择了 11 个主题进行进一步讨论,其中 6 个被投票决定在两轮连续讨论中进行更深入的讨论。主要主题是临床试验中糖皮质激素的最佳处理、改善结局指标、减少或控制安慰剂反应以及鉴定生物标志物和分层参数。此外,还强调了本地和国际网络的重要性。通过联网,可以促进合作,更有效地招募患者,并协调治疗,从而使 SLE 试验更成功。需要进一步讨论来证实结果并开发新的试验设计。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/306d/8141446/ca76afd5e876/lupus-2021-000506f01.jpg

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