Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source.
Timing of pivotal clinical trial results reporting for newly approved medications varied by reporting source.
复制标题
新批准药物的关键临床试验结果报告时间因报告来源而异。
DOI：
10.1016/j.jclinepi.2016.04.007
复制
发表时间：
2016
影响因子：
7.2
通讯作者：
Hartung,DanielM
中科院分区：
文献类型：
--
作者：
Withycombe,Bethany;Ovenell,Mac;Meeker,Amanda;Ahmed,ShariaM;Hartung,DanielM
研究设计和设置我们检查了2009年至2013年美国食品和药物管理局（FDA）批准的新分子实体（NME）的关键临床试验结果的可用性。对于每个NME，我们量化的时间，从批准日期，直到结果可在FDA网站上，在ClinicalTrials.gov基本结果数据库，并在医学journal. ResultsTwenty一百五十五个关键试验支持88 NME符合我们的标准。在FDA网站ClinicalTrials.gov和出版物上获得关键试验结果的中位时间分别为42天、27天和-28天。在批准后的前30天内，52%的关键性试验在ClinicalTrials.gov上进行了总结，20%发布在FDA网站上，46%发表在期刊上。在所有来源中，79%的关键试验在批准后30天内获得结果。从2009年到2013年，根据联邦消息来源，公开上市的平均时间有所改善。结论新批准药物的关键试验首先出现在出版物中。大多数关键性试验的结果在批准后30天内可在某些来源公开获得。
ObjectiveThe study aimed to characterize the public availability of pivotal clinical trial results for newly approved drugs.Study Design and SettingWe examined the availability of pivotal clinical trial results for new molecular entities (NMEs) approved by the US Food and Drug administration (FDA) from 2009 to 2013. For each NME, we quantified the time from approval date until results were available on the FDA web site, in the ClinicalTrials.gov basic results database, and in a medical journal.ResultsTwo hundred fifty-five pivotal trials supporting 88 NMEs met our criteria. The median time until pivotal trial results were available on the FDA web site, ClinicalTrials.gov, and in a publication was 42 days, 27 days, and −28 days, respectively. In the first 30 days after approval, 52% of pivotal trials were summarized in ClinicalTrials.gov, 20% were posted to the FDA web site, and 46% were published in a journal. Across all sources, 79% of pivotal trials had results available within 30 days of approval. From 2009 to 2013, the average time until public availability has improved for federal sources.ConclusionsPivotal trials of newly approved drugs appeared first in publications. Results from most pivotal trials were publicly available in some source within 30 days of approval.