Trial registration at ClinicalTrials.Gov between May and October 2005
Trial registration at ClinicalTrials.Gov between May and October 2005
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DOI：
10.1056/nejmsa053234
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发表时间：
2005-12-29
影响因子：
158.5
通讯作者：
Ide, NC
中科院分区：
文献类型：
--
作者：
Zarin, DA;Tse, T;Ide, NC
背景临床试验注册允许有关各方获得正在进行和已完成的试验的信息，但很少有数据表明注册过程中提供的信息的质量。我们使用公开的ClinicalTrials.gov数据库中的信息来描述期刊编辑实施新政策之前和之后的试验注册模式，该新政策要求注册为publication.MethodsWe的先决条件，我们回顾了ClinicalTrials.gov记录，以确定在2005年5月20日和10月11日注册的试验的“干预名称”和“主要结果测量”数据字段的完成模式。结果在研究期间，www.example.com的注册数量ClinicalTrials.gov从13，153增加到22，714，增加了73%。按行业登记的非特定干预名称条目（归因于四家制药公司）的干预性试验百分比从10%下降到2%;所有其他行业和非行业记录都包含该字段的特定条目。在这两个日期之间按行业登记的2670项研究中，76%提供了主要结局指标领域的信息，尽管这些条目的特异性程度差异很大。在其余的24%的记录，这个字段是blank.ConclusionsDuring 2005年夏天，有大量增加的临床试验注册的数量。总体而言，10月份记录中的数据比5月份更完整，但仍有大幅改进的余地。
BackgroundClinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication.MethodsWe reviewed ClinicalTrials.gov records to determine patterns of completion of the "Intervention Name'' and "Primary Outcome Measure'' data fields for trials registered on May 20 and October 11, 2005, and for trials registered during the interval between these two dates, inclusively.ResultsDuring the interval studied, the number of registrations in ClinicalTrials.gov increased by 73 percent from 13,153 to 22,714. The percentage of interventional trials registered by industry with nonspecific Intervention Name entries (attributable to four drug companies) decreased from 10 percent to 2 percent; all other industry and nonindustry records contained specific entries in this field. Of the 2670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24 percent of the records, this field was blank.ConclusionsDuring the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than they were in May, but there still is room for substantial improvement.