重庆市药物临床试验研究者GCP参培现状调查

Investigation on Current Status of Clinical Trial Researchers Participating in GCP Training in Chongqing

目的提高重庆市药物临床试验质量管理规范(GCP)培训水平。方法选择重庆市22家药物临床试验机构的临床试验研究者(简称研究者),以调查问卷的形式,对其接触GCP培训的时间、参加GCP学习的途径与方法、医院及科室开展GCP培训频次、研究者自行参与GCP培训情况、现有GCP培训班是否满足研究者需求及存在的缺陷等情况进行调查,以了解该市研究者规范化GCP参培现状,分析该市GCP培训现存问题并提出相应策略。结果现场发放问卷190份,事后均成功回收,其中有效问卷177份,有效回收率为93.16%。当前,该市GCP培训存在一定的问题,包括研究者接触GCP培训时间较晚;医院内部组织学习GCP频次少且重视程度低;培训内容在专家讲解热点难点、实战GCP案例教学等方面有一定欠缺。研究者不参加培训的原因多为工作太忙没时间、培训地点与教育方式不方便、培训流于形式且“干货”少、培训费高等。结论重庆市当前GCP培训存在普及程度不够、医院及科室重视不足、现有GCP培训班存在缺陷等问题。可试点医学院校设立临床试验相关必修和选修课程,鼓励各医院及科室开展GCP相关培训,建设跨产学研的药物临床试验培训专家库,并组建专业化培训课程建设团队等措施。GCP培训班则应增加专家讲解热点难点、实战案例教学等内容,并提高培训趣味性,以及采用多地点多方式培训,进一步构建重庆市临床试验培训线上和线下平台,降低培训费用,避免疾病感染风险,建立适合该市研究者继续培训的创新模式及方式。

Objective To improve the training level of Good Clinical Practice(GCP)in Chongqing.Methods Clinical trial researchers(hereinafter referred to as researchers)from 22 drug clinical trial institutions in Chongqing were selected,a questionnaire survey was conducted on their time of exposure to GCP training,ways and methods of participating in GCP learning,GCP training frequency of hospitals and departments,self participation in GCP training,whether the existing GCP training courses met the needs and defects to know the current status of researchers participating in GCP training in the city,and analyze the existing problems of GCP training in the city.The corresponding strategies were put forward.Results A total of 190 questionnaires were distributed on-site,all of which were successfully recovered,including 177 valid questionnaires,with an effective recovery rate of 93.16%.At present,the GCP training in this city had the following problems:researchers were exposed to GCP training late,the internal organization of the hospital had a low frequency and low emphasis on GCP learning,the content of GCP training was lacking in experts'explanation of hot and difficult points and practical teaching.Most of the reasons why researchers did not participate in the training were lack of time caused by busy work,inconvenient training place and education mode,formalistic training,less″real McCoy″and higher training fee.Conclusion There are some problems in the current GCP training in Chongqing,such as the popularization of GCP training is insufficient,hospitals and departments has low emphasis on GCP learning,and the existing GCP training courses have defects.In view of the above problems,Chongqing can pilot medical colleges to set up compulsory and elective courses related to clinical trials,encourage hospitals and departments to carry out GCP-related training,build a cross-industry-university-research clinical trial training expert database,and set up a professional training course construction team.The GCP training courses should be increase experts'explanation of hot spots and difficulties,practical case teaching and other contents,increase training interest,multi-location and multi-method training to build online and offline platforms for clinical trial training in Chongqing,reduce training costs,avoid the risk of disease infection,and establish innovative models and methods for continuing training for researchers in Chongqing.