TY -非盟的El伊玛目哈立德AU -彼特,伊丽莎白AU -桑普森,玛格丽特AU - Krleža-Jerić,Karmela盟——Neisa当归PY - 2009 DA - 2009/3/09 TI -在临床试验中使用电子数据采集工具:网络调查259名加拿大试验乔- J地中海互联网Res SP - e8六世- 11 - 1 KW -临床试验千瓦-创新扩散KW -电子数据捕获KW -数据收集AB -背景:电子数据捕获(EDC)工具为临床试验的数据收集、报告、查询解析、随机化和验证等功能提供自动化支持。在临床试验中有更多地采用EDC工具的趋势，但在实践中有多少试验实际使用了这种技术也存在不确定性。对截至2007年进行的EDC采用调查的系统回顾得出结论，只有20%的试验使用了EDC系统，但以前的调查存在缺陷。目的:我们的主要目的是估计2006年和2007年加拿大II/III/IV期临床试验中使用EDC系统的比例。次要目标是调查可能对采用产生影响的因素，并制定一个量表来评估EDC系统的复杂程度。方法:我们进行了一项网络调查，以估计使用EDC系统的试验比例。这项调查被发送给加拿大的地点协调员进行331次试验。我们还开发并验证了使用Guttman标度来评估EDC系统的复杂程度的量表。使用EDC的试验根据其系统的复杂程度进行比较。 Results: We had a 78.2% response rate (259/331) for the survey. It is estimated that 41% (95% CI 37.5%-44%) of clinical trials were using an EDC system. Trials funded by academic institutions, government, and foundations were less likely to use an EDC system compared to those sponsored by industry. Also, larger trials tended to be more likely to adopt EDC. The EDC sophistication scale had six levels and a coefficient of reproducibility of 0.901 (P< .001) and a coefficient of scalability of 0.79. There was no difference in sophistication based on the funding source, but pediatric trials were likely to use a more sophisticated EDC system. Conclusion: The adoption of EDC systems in clinical trials in Canada is higher than the literature indicated: a large proportion of clinical trials in Canada use some form of automated data capture system. To inform future adoption, research should gather stronger evidence on the costs and benefits of using different EDC systems. SN - 1438-8871 UR - //www.mybigtv.com/2009/1/e8/ UR - https://doi.org/10.2196/jmir.1120 UR - http://www.ncbi.nlm.nih.gov/pubmed/19275984 DO - 10.2196/jmir.1120 ID - info:doi/10.2196/jmir.1120 ER -