上海市级医院临床研究中心建设现状及临床研究者的服务需求分析

Analysis on the construction status of clinical research center in Shanghai municipal hospital and the service demand of clinical researchers

目的了解市级医院临床研究中心的建设现状和临床研究中心为临床研究项目负责人提供临床研究服务情况,为推进医院临床研究中心内涵建设提供依据。方法纳入35家市级医院临床研究中心负责人和市级医院临床研究项目负责人345例,应用问卷星收集相关信息。应用SAS9.3软件进行统计分析。结果 35家市级医院均已成立临床研究中心,22家医院设置为一级处/科(62.86%),配置专业人员数的中位数为10例[四分位间距(interquartile range,IQR):6~19]。市级医院临床试验管理系统、电子数据采集系统、中央随机化系统、生物样本库、研究型病房的建立比例分别为68.57%、71.43%、31.43%、82.86%和68.57%。345例临床研究项目负责人获得"临床研究方案设计""统计分析""临床研究随机化"服务的比例分别为67.25%、58.55%和41.74%;而对"临床研究方法学培训"、"创建数据库""统计分析""CRA协助项目质控""经费管理和审计""CRC协助数据采集"需求比例分别为94.78%、78.55%、68.99%、62.32%、48.12%和42.61%。结论市级医院临床研究中心建设情况整体良好,但部分医院仍存在专业人员配置不足,信息系统建设滞后及临床研究方法学支撑不足等问题,今后需加强临床研究服务内涵建设。

Objectives To investigate the status of clinical research center construction in municipal hospitals and the clinical research service provided by clinical research center to the person in charge of clinical research project,and to provide the basis for promoting the connotation construction of clinical research center in hospitals.Methods A total of 35 persons in charge of clinical research centers and 345 researchers in charge of clinical research projects in 35 municipal hospitals were included.Relevant information was collected by questionnaire.SAS9.3 software was used for statistical analysis.Results Clinical research centers were established in 35 municipal hospitals,and the median number of professional staff was 10[interquartile range(IQR):6~19.The allocation proportion of clinical trial management system,electronic data acquisition system,central randomization system,biofilm bank and research ward in municipal hospitals were 68.57%,71.43%,31.43%,82.86% and 68.57%,respectively.The service acquired proportions of "clinical study protocol design","statistical analysis" and "clinical study randomization" from CRC of hospitals were 67.25%,58.55% and 41.74% among 345 clinical study project leaders,respectively.The demand proportion for "clinical research methodology training","database creation","statistical analysis","CRA assisted project quality control","fund management and audit" and "CRC assisted data collection" were 94.78%,78.55%,68.99%,62.32%,48.12% and 42.61%,respectively.Conclusion The construction of clinical research centers in municipal hospitals is good on the whole,but some hospitals still have problems such as insufficient professional staff allocation,lagging information system construction and insufficient clinical research methodology support.The connotation construction of clinical research services should be strengthened in the future.