摘要
随着制药行业的国际化发展和临床试验的产业化大趋势,国际竞争日益增加,提高临床试验质量是首要的竞争手段,而有效的管理机制是保证临床试验质量的强有力途径。本文结合多年的临床研究工作管理经验及现行的运行管理模式,对我院根据国家药物临床试验相关法规指导药物临床试验机构建设和管理的具体做法进行探讨和总结。研究认为,加强对软硬件的投入和建设、加强对临床试验质量和试验过程的管理、制定完备的管理制度和标准操作规程、建立规范化的管理模式,将有利于提高试验水平,保证临床试验质量,为我国新药审评和批准上市提供科学、准确、可靠的依据。
With the international development of the pharmaceutical industry and the industrialization trend of clinical trials, the international competition is increasing. The primary means of competition is improving the quality of clinical trials and the effective management mechanism is the powerful guarantee of the quality of clinical trials. According to the experience on clinical research management in many years and nowaday operation and management model, the paper explored and summarized the practice of construction and management of hospital clinical drug trial institution in accordance with the relevant laws and regulations. Strengthening the investment and construction of software and hardware, strengthening the management on quality and process of clinical trials, developing a comprehensive management system and standard operating procedures, and establishing a standardized management mode will be beneficial to improve the level of clinical trial and ensure quality of clinical trials, so as to provide scientific, accurate and reliable basis for the evaluation and approval of new drugs in China.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2013年第5期362-365,共4页
Chinese Journal of New Drugs and Clinical Remedies
基金
国家十二五"重大新药创制"科技重大专项(2011ZX09302-007-03)
关键词
药物临床试验机构
组织和管理
全面质量管理
drug clinical trial institution
organization and administration
total quality management
