中国临床药学杂志

目的分析重庆市研究者参加临床试验现状及其影响因素,探讨重庆市临床试验水平及质量提升的方法及可行的对策。方法选择重庆市各临床试验机构的研究者,以调查问卷的形式,对其年龄、职称、参加临床工作的年限、参与临床试验的基本情况等方面进行调查。结果年龄30～39岁、工作年限5～15年的研究者为临床试验的主力军;研究者中硕士及以上学历人群占比达60.45%,副高及以上人群占比为43.50%;有88.24%的研究者不愿参与临床试验的原因为时间不足,有68.92%的研究者近3年来承接的注册试验(含器械)项目数≤3个,甚至有23.16%的研究者近3年来未承接过注册试验(含器械);研究者所在医院中,高达63.95%医院未针对参与临床试验的研究者给予晋升优先和资金的奖励。结论重庆市研究者参与临床试验积极性及临床试验相关教育水平亟待提高。可采取设立专职研究者,改革绩效考核、职称评定等激励措施,以提高研究者参与临床试验的积极性。

AIM To analyze the status quo and influencing factors of researchers participating in clinical trials and explore the methods and feasible countermeasures for improving the level and quality of clinical trials in Chongqing.METHODS Questionnaire was used to investigate the age, professional title, years of clinical work and basic situation of clinical trial participation of researchers in various clinical trial institutions in Chongqing. RESULTS Researchers aged 30 to 39 and working for 5 to 15 years were the main force of clinical trials in Chongqing. The proportion of researchers with master's degree or above was 60.45%, and the proportion of researchers with deputy senior degree or above was 43.50%. The 88.24% of researchers were unwilling to participate in clinical trials because of limited time, 68.92%of researchers undertook no more than 3 registered trials(including devices) and even 23.16% of researchers did not undertake any registered trials(including devices) in the past 3 years. In the hospital where the researchers worked, up to 63.95% of hospitals did not give researchers participating in clinical trials the promotion priority and financial rewards.CONCLUSION It is urgent to improve the enthusiasm and the level of education related to clinical trial of researchers to participate in clinical trials in Chongqing. We can set up the position of full-time researchers, reform performance appraisal, professional title evaluation and other incentive measures to improve the enthusiasm of researchers to participate in clinical trials.