Ramagopalan Sreeram V, Skingsley Andrew P, Handunnetthi Lahiru, Magnus Daniel, Klingel Michelle, Pakpoor Julia, Goldacre Ben
SVR Consulting, London, UK.
Imperial College Medical School, London, UK.
F1000Res. 2015 Mar 26;4:80. doi: 10.12688/f1000research.6312.2. eCollection 2015.
We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov.
A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date.
13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .
Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.
我们和其他人已经表明，在ClinicalTrials.gov上注册的相当一部分干预性试验在列出的研究开始和完成日期之后改变了其主要结局。本研究的目的是调查对主要结局的改变是否与在ClinicalTrials.gov上报告具有统计学意义的主要结局的可能性相关。
对截至2014年11月20日在ClinicalTrials.gov上注册的所有干预性临床试验进行横断面分析。主要结局是对最初列出的主要结局的任何改变以及该改变相对于试验开始和结束日期的时间。
13238项完成的干预性试验在ClinicalTrials.gov上注册，并且在该网站上发布了研究结果。2555项（19.3%）有一个或多个具有统计学意义的主要结局。统计分析表明，注册年份、资金来源和试验完成后主要结局的改变与报告具有统计学意义的主要结局相关。
资金来源和试验完成后主要结局的改变与在ClinicalTrials.gov上报告具有统计学意义的主要结局相关。
