口腔专科医院药物临床试验机构管理现状的调查

Investigation on the management status of clinical trial institution in stomatological hospitals

目的了解口腔专科医院药物临床试验机构现状,分析口腔专科医院临床试验管理问题并提出相应的建议。方法截至2022年1月,在国家药品监督管理局“药物临床试验机构备案管理信息系统”备案的13家口腔专科医院药物临床试验机构作为调查对象,通过问卷星方式进行调查,对收集的数据进行统计分析,并针对机构管理存在的问题提出建议。结果共发放问卷13份,回收13份。调查结果显示,各机构均配置专职人员负责临床试验工作,每年承接的药物临床试验均不超过1项,仅1家参与过国际多中心的项目。13家机构依据工作实际选择不同方式管理试验药物,有9家机构建立了临床试验中心药房,但整体面积较小。各机构质控频率均按照试验阶段(试验前、中、后)进行,有11家机构采用三级质量控制体系,实行1人全程负责模式。12家机构临床试验相关人员的培训由机构办公室负责并组织实施。结论目前口腔专科医院药物临床试验机构在人员架构、试验药品管理、人员培训和质量管理等方面基本符合管理要求。后续应在人员专职化建设、伦理审查结果互认、临床试验全过程信息化、试验药物集中化管理和完善质控体系方面加强,促进口腔专科医院临床试验机构的高质量发展。

AIM To understand the current situation of clinical trial institutions in stomatological hospitals in China,and to analyze the problems of clinical trial management in stomatological hospitals and put forward corresponding suggestions.METHODS Until January 2022,the 13 clinical trial institutions in oral hospitals recorded in the"Clinical Trial Institution Record Management Information System"of the National Medical Products Administration were investigated through the questionnaire in the form of star for statistical analysis of data collected and suggestions for clinical trial institution management were put forward.RESULTS A total of 13 questionnaires were distributed and 13were recovered.The survey results showed that all institutions had assigned full-time staff to take charge of clinical trials,and undertook no more than 1 drug clinical trials per year,only 1 institution participated in international multi-center clinical trials.The 13 institutions chose different ways to manage experimental drugs according to the actual work,and 9 institutions established clinical trial pharmacy,but the overall area was small.The quality control frequency of each institution was carried out according to the clinical trial phase(before,during and after trial),11 institutions adopted the three-level quality control system,and implemented the whole-process responsibility mode of one person.The training of clinical trial in 12 institutions was organized and implemented by the institutional office.CONCLUSION The clinical trial institutions of stomatological hospitals basically meet the management requirements in personnel structure,experimental drug management,personnel training,and quality management.In the follow-up,efforts should be intensified in the construction of professional personnel,mutual recognition of ethical review results,information of the whole process of clinical trial,centralized management of experimental drugs,and improvement of the quality control system to promote the high-quality development of clinical trial institutions in stomatological hospitals.