Is the future for clinical trials internet-based? A cluster randomized clinical trial
Is the future for clinical trials internet-based? A cluster randomized clinical trial
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DOI：
10.1191/1740774505cn069oa
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发表时间：
2005-01-01
期刊：
影响因子：
2.7
通讯作者：
Chubb, B
中科院分区：
文献类型：
--
作者：
Litchfield, J;Freeman, J;Chubb, B
目的比较网络数据采集与传统纸质数据记录在临床试验中的效率和易用性。设计多中心、聚类随机临床试验。英国的全科医生。主要结果测量：研究里程碑、查询、数据输入和监测时间的计时；调查员QuestionnaireResults。结果网络源性数据库在患者最后一次就诊后33天就可以发布，而纸质源性数据库在最后一次就诊后48天就可以发布，尽管网络源性数据库的患者数量要多得多。就诊至数据录入的平均时间分别为10.2 （SD 18.9）天和95.4 （SD 44.6）天（P < 0.01）。从访问到解决查询的平均时间分别为121.4 （SD 58.3）天和182.1 （SD 58.9）天（P < 0.01）。研究人员的研究后反应是积极的。71%的研究中心表示，他们更愿意在未来的研究中使用互联网而不是纸质的CRI。与基于纸张的系统相比，在数据输入、查询解析和数据库发布时间方面，使用基于互联网的系统可以提高效率。调查人员对互联网系统的反应总体上是有利的，尽管调查人员平均报告说花在研究上的时间增加了。通过改进程序设计，提高研究者对互联网系统的熟悉程度，以及为赞助者的监督员和数据库人员采用新的工作方法，可以进一步提高效率。
Objective To compare the efficiency and ease of use of internet data capture compared with conventional paper based data recording in the conduct of a clinical trial.Design Multicentre, cluster randomized clinical trial.Setting General practice in the UK.Main outcome measures Timings for study landmarks, queries, data entry and monitoring time; Investigator QuestionnaireResults. Results The internet-derived database was ready for release 33 days after the last patient visit compared with 48 days for the paper-derived database, despite much higher numbers of patients in the internet group. The mean times from visit to data entry were 10.2 (SD 18.9) days and 95.4 (SD 44.6) days respectively (P < 0.01). The mean times from a visit to a query being resolved were 121.4 (SD 58.3) days and 182.1 (SD 58.9) days respectively (P < 0.01). The post-study responses from investigators were positive. Seventy-one percent of centres said they would prefer to use the internet rather than paper CRI's for future studies.Conclusions There were efficiency gains seen with the use of an internet-based system when compared with a paper-based system in terms data entry, query resolution and the time to the release of the database. The investigators' response to the internet system was generally favourable although on average investigators reported increased time spent on the study. Further efficiency might be gained with improved programming, increased investigator familiarity with the internet system, and with newly adapted working practices for sponsors' monitors and database personnel.