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A call for more transparency of registered clinical trials on endometriosis.

机译:呼吁提高子宫内膜异位症注册临床试验的透明度。

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摘要

In response to the pressing need for more efficacious and safer therapeutics for endometriosis, there have been numerous reports in the last decade of positive results from animal and in vitro studies of various compounds as potential therapeutics for endometriosis. A handful of these have undergone phase II/III clinical trials. Since the announcement of the International Committee of Medical Journal Editors that mandated registration as a prerequisite for publication, 57 endometriosis-related clinical trials have been registered at ClinicalTrials.gov, an Internet-based public depository for information on drug studies. Among them, 25 are listed as completed, and 2 as suspended. There are 15 completed phase II/III trials, which evaluated the efficacy of various promising compounds. Yet only three of the 15 trials (20%) have published their results. The remaining 12 (80%) studies so far have not published their findings. We argue that this apparent lack of transparency will actually not benefit the trial sponsors or the public, and will ultimately prove detrimental to research efforts attempting to develop more efficacious and safer therapeutics for endometriosis. Thus we call for more transparency of clinical trials on endometriosis.
机译:响应对子宫内膜异位症的更有效和更安全的疗法的迫切需求,在过去的十年中,已经有许多报道了对各种化合物作为子宫内膜异位症的潜在疗法的动物和体外研究的积极结果。其中一些已经过II / III期临床试验。自国际医学杂志编辑委员会宣布将注册作为出版的先决条件以来,已有57项与子宫内膜异位症相关的临床试验已在ClinicalTrials.gov上注册,ClinicalTrials.gov是一个基于互联网的公共库,提供有关药物研究的信息。其中25个列为已完成,2个列为已暂停。有15个完成的II / III期试验,评估了各种有前途的化合物的功效。但是15个试验中只有3个(20%)公布了结果。到目前为止,其余12项研究(80%)尚未发表他们的发现。我们认为这种明显的缺乏透明度实际上不会使试验的申办者或公众受益,并且最终将证明不利于为子宫内膜异位症开发更有效,更安全的疗法的研究工作。因此,我们呼吁子宫内膜异位症的临床试验更加透明。

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