An overview of the current status of clinical trials on endometriosis: issues and concerns
An overview of the current status of clinical trials on endometriosis: issues and concerns
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子宫内膜异位症临床试验现状概述：问题和担忧
DOI：
10.1016/j.fertnstert.2013.08.050
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发表时间：
2014-01-01
影响因子：
6.7
通讯作者：
Guo, Sun-Wei
中科院分区：
文献类型：
--
作者：
Guo, Sun-Wei
目的：检查和比较产业界和非产业界赞助的子宫内膜异位症临床试验之间的差异（如果有的话），并评估先前发表的阳性临床前结果或缺乏临床前结果对试验状态的影响。设计：子宫内膜异位症临床试验的横断面研究，评估截至2013年7月3日在ClinicalTrials.gov注册的药物/生物制剂。单位：学校附属医院。病人:没有。干预:没有。主要结局指标：试验状态、规模、阶段和持续时间；使用比较国组；毒品类别、武器数量、目标条件；以及在试验开始前是否存在阳性的临床前结果。结果：确定了80个试验。由工业和非工业赞助的试验在试验状态、阶段、比较物、药物类别、组数、试验规模和持续时间等方面具有明显的特点。II/III期试验主要由工业界支持，但这些试验经常使用安慰剂作为比较剂。没有事先发表临床前结果的试验似乎进展不太顺利，尽管这类研究的存在并不能保证成功。结论：在大多数情况下，关于试验药物是否真的优于现有最佳药物或其成本效益概况的问题被忽视了。似乎有大量的“模仿”药物，它们比现有药物具有模棱两可的优势和成本效益。由于临床试验非常耗时，目前尚无治疗子宫内膜异位症的重磅药物问世。肥料(R) 2014；101: 183 - 90。(C) 2014年由美国生殖医学学会发布。)
Objective: To examine and compare differences, if any, between industry- and nonindustry-sponsored clinical trials on endometriosis and to evaluate the effect of prior published positive preclinical results, or lack thereof, on trial status.Design: Cross-sectional study of clinical trials on endometriosis that evaluate drugs/biologicals registered at ClinicalTrials.gov as of July 3, 2013.Setting: University-affiliated hospital.Patient(s): None.Intervention(s): None.Main Outcome Measure(s): Trial status, size, phase, and duration; use of comparator groups; drug classes, number of arms, targeting conditions; and presence or absence of prior positive preclinical results before the launch of the trial.Result(s): Eighty trials were identified. The trials sponsored by industry and non-industry have distinct features, differing in trial status, phase, comparator, drug classes, number of arms, trial size, and duration. The phase II/III trials are predominantly industry supported, but these trials frequently use placebo as the comparator. Trials launched without prior published preclinical results do not seem to fare well, although the presence of such studies is no guarantee for success.Conclusion(s): Questions as to whether the drug on trial is truly superior to the best available drug or of its cost-benefit profile are overlooked in most cases. There seems to be a deluge of "me-too'' drugs with equivocal superiority over existing drugs and cost-benefit profiles. Because clinical trials are time-consuming, no blockbuster drug for endometriosis seems to be on the horizon yet. (Fertil Steril (R) 2014; 101: 183-90. (C) 2014 by American Society for Reproductive Medicine.)