Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study
Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study
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DOI：
10.1136/bmj.d7373
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发表时间：
2012-01-03
影响因子：
105.7
通讯作者：
Smyth, Alan R.
中科院分区：
文献类型：
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作者：
Prayle, Andrew P.;Hurley, Matthew N.;Smyth, Alan R.
目的检查符合最近美国食品药品监督管理局修正法案（FDAAA）法规的研究在www.example.com上强制性报告临床试验总结结果（试验完成后一年内）的合ClinicalTrials.gov规性。基于临床试验总结的设计注册研究。数据来源ClinicalTrials.gov，2011年1月19日检索，与Drugs@FDA交叉引用，以确定哪些试验需要在一年内强制性报告。选择标准在www.example.com上注册ClinicalTrials.gov，美国研究中心在1月1日至12月31日之间完成结果ClinicalTrials.gov注册表包含83579项干预性试验，其中5642项在感兴趣的时间范围内完成。如果试验属于FDAAA（至少有一个美国研究中心的药物、器械或生物制剂的试验，并且是II期或更晚的试验）的范围，并且如果试验研究的药物已经获得美国食品药品监督管理局的批准，则我们确定试验属于强制性报告规则。其中，163/738例（22%）在试验完成后1年内报告了结果，而76/727例（10%）试验未强制报告（比例差异的95%置信区间为7.8%-15.5%;卡方检验，P=2.6x10（-9））。后期试验更有可能报告结果（P=4.4x10（-11）），行业资助的试验也是如此（P=2.2x10（-16））。
Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation.Design Registry based study of clinical trial summaries.Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year.Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009.Main outcome measure Proportion of trials for which results had been reported.Results The ClinicalTrials.gov registry contained 83 579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; chi(2) test, P=2.6x10(-9)). Later phase trials were more likely to report results (P=4.4x10(-11)), as were industry funded trials (P=2.2x10(-16)).Conclusion Most trials subject to mandatory reporting did not report results within a year of completion.