重庆地区临床试验机构现状分析

Analysis of Clinical Trial Institutions in Chongqing Area

关键词:  临床试验  临床试验机构  问卷调研

Key words:  clinical trials  clinical trial institutions  questionnaire survey

摘要:

目的 调研临床试验机构备案制后重庆市临床试验机构现状，并提出建议。方法 以重庆市34家临床试验机构为调研对象发放问卷，调研内容主要包括机构基本情况、人员配备和软硬件建设情况、项目运行情况和工作难点等方面，并结合调研结果，针对新、老机构在临床试验机构运行中各自的难点问题提出建议。结果 共收回问卷29份，有效问卷29份。重庆市临床试验存在资源释放不够充分、不均匀，激励政策不足，信息化平台建设欠缺以及从业人员数量和专业度需提升等问题。临床试验新机构在项目负荷、办公场地和承接意愿上具备一定优势，但受主要研究者资质、项目经验和机构名气等方面的制约。结论 建议明确激励机制，增强各机构临床试验开展积极性并建立规范化培养临床试验专业人员机制；充分利用信息化平台，提升临床试验开展效率，并构建区域信息化平台实现信息和资源共享，加快区域临床试验工作发展。

Abstract:

OBJECTIVE To investigate the current situation of clinical trial institutions in Chongqing after the recording system of clinical trial institutions, and to put forward suggestions. METHODS A total of 34 clinical trial institutions in Chongqing were selected as the research objects. The research contents mainly included the basic situation of the institutions, staffing, hardware and software construction, project operation and work difficulties, etc. Combined with the research results, suggestions were put forward for the difficulties of the new and old institutions in the operation of clinical trial institutions. RESULTS A total of 29 questionnaires were collected and 29 were valid. The release of clinical trial resources in Chongqing were not sufficient and uniform, there were problems such as insufficient incentive policies, lack of information platform construction, and the number and professional degrees of practitioners need to be improved. The new institutions had certain advantages in project load, office space and willingness to undertake, but it was restricted by principle investigator qualification, project experience and institutional reputation. CONCLUSION It is suggested to clarify the incentive mechanism, enhance the enthusiasm of clinical trials and establish a standardized training mechanism for clinical trial professionals. Make full use of the information platform to improve the efficiency of clinical trials, build a regional information platform to share information and resources, and accelerate the development of regional clinical trials.