探索提高药物临床试验机构的核心竞争力

Approaches to Improve the Core Competitive Power of Drug Clinical Trial Institutions

目的:为药物临床试验机构提高新药Ⅰ～Ⅳ期临床试验的质量,保障受试者权益,增强核心竞争力提供参考。方法:将《药物临床试验质量管理规范》(GCP)的指导原则和《检测和校准实验室能力的通用要求》(ISO/IEC17025)质量管理标准优势互补,贯穿于药物临床试验质控的全过程。结果与结论:将GCP的原则和ISO/IEC17025质量管理标准结合,建立既符合国际规范,又符合我国国情的质量管理及督察体制,有利于全面提高药物临床试验研究质量,增强我国药物临床试验机构的核心竞争力。

OBJECTIVE： To provide references for improving the quality of clinical trial of new drug （phase Ⅰ-Ⅳ）, guaranteeing participants＇ interests and enhancing the core competitive power of drug clinical trial institutions. METHODS： The advantages of both the guiding principle of Good Clinical Practice （GCP） and the quality standards of ISO/IEC17025：2005 were applied throughout the quality control process of clinical drug trial. RESULTS ＆ CONCLUSIONS： To establish quality management and supervision system in China that is in line with the international norm and national condition by combining GCP principle with the quality standards of ISO/IEC17025 is conducive to the improvement of the quality of clinical drug trial and enhancement of the core competitive power of drug clinical trial institutions in China.