Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, New York, United States of America.
PLoS Med. 2009 Sep;6(9):e1000144. doi: 10.1371/journal.pmed.1000144. Epub 2009 Sep 8.
ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.
We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515), nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46%) of trials were published, among which 96 (31%) provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357) were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001), but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22). Among trials that reported an end date, 75 of 123 (61%) completed prior to 2004, 50 of 96 (52%) completed during 2004, and 62 of 149 (42%) completed during 2005 were published (p = 0.006).
Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data elements, the potential for ClinicalTrials.gov to address selective publication of clinical trials will be limited. Please see later in the article for the Editors' Summary.
ClinicalTrials.gov 是一个公共可访问的、基于互联网的临床试验注册库，由美国国家医学图书馆管理，它具有解决选择性试验发表的潜力。我们的目标是检查 ClinicalTrials.gov 内注册的完整性，并确定选择性发表的程度和相关性。
我们检查了在 1999 年 12 月 31 日后在 ClinicalTrials.gov 注册并在 2007 年 6 月 8 日前更新为已完成的试验中报告的注册信息，不包括 I 期试验。然后，我们通过使用系统协议搜索 MEDLINE，从随机抽取的 10%样本中确定了试验的出版状况，其中排除了 2005 年 12 月 31 日后完成的试验，以确保至少在完成后 2 年内发表。在完整的完成试验样本（n=7515）中，几乎 100%报告了 ClinicalTrials.gov 要求的所有数据元素，如干预和赞助。可选数据元素的报告有所不同，其中 53%报告了试验结束日期，66%报告了主要结局，87%报告了试验开始日期。在 10%的样本中，不到一半（311 个中的 677 个，46%）的试验发表了，其中 96 个（31%）在 ClinicalTrials.gov 中引用了一篇描述试验结果的出版物。主要由工业界赞助的试验（40%，144 个中的 357 个）与非工业/非政府赞助的试验（56%，110 个中的 198 个；p<0.001）相比，发表的可能性较小，但与政府赞助的试验（47%，57 个中的 122 个；p=0.22）相比，差异无统计学意义。在报告了结束日期的试验中，75 个（123 个中的 61%）在 2004 年前完成，50 个（96 个中的 52%）在 2004 年完成，62 个（149 个中的 42%）在 2005 年完成（p=0.006）。
可选数据元素的报告存在差异，在 ClinicalTrials.gov 中注册的已完成试验的发表率较低。如果不更加重视所有数据元素的报告，ClinicalTrials.gov 解决临床试验选择性发表的潜力将受到限制。请在文章后面查看编辑摘要。
