我国影像临床试验注册情况及其对科研管理的启示

Analysis of the Registration of Radiological Clinical Trials and Hints for Science Research Management

目的分析和探讨我国影像医学临床试验注册现状及存在的问题。方法收集中国临床试验注册中心2008—2012年的临床试验注册数据,使用SPSS16.0软件进行统计分析,组间构成比比较采用Pearsonχ2检验。结果5年间我国影像医学临床试验注册数呈明显上升趋势。2011—2012年注册试验的影像手段构成与2008—2010年注册试验不同,P=0.037,MRI(从18.18%到32.73%)、CT(从9.09%到18.18%)试验所占比例明显升高。影像医学临床试验采用诊断试验设计的比例最高,占37.98%,明显高于平均水平3.45%,P<0.001。结论我国影像临床试验的管理逐渐规范,临床试验的科学性和可信度随之提高。加强临床试验预注册、完善试验设计是提高影像医学试验管理水平的重要措施。

Objective To investigate and discuss the registration of radiological clinical trials in China. Methods The regis-tration data of clinical trials from 2008 to 2012 were collected from ChiCTR. The statistical analysis was conducted with SPSS 16.0. Pearson x2 test was used to compare inter-group proportions. Results The number of registered radiological clinical trials kept rising in five years. The constitution of trials registered from 2011 to 2012 was obviously different from that from 2008 to 2010, P=0.037. The trials using MRI （from 18.18% to 32.73%） and CT （from 9.09% to 18.18%） took higher percentage. 37.98% of radiological clinical trials applied the diagnostic accuracy trial design, which was signifi-cantly higher than the average level of 3.45%, P〈0.001. Conclusion The management of radiotogical clinical trials in China has been gradually standardized, which improves the scientificness and reliability of clinical trials. It is of great importance to enhance pre-registration and improve design for promoting the management of radiological clinical trials.