效率与质量的平衡——构建多中心临床试验伦理审查协调体系与平台的设想

Balance of efficiency and quality:conceiving a new framework of multi-center clinical trial ethical review system and coordination platform

随着近年来国内医疗机构承担的多中心临床药物试验项目不断增加,开展这些项目必须的伦理审查出现的质量不一致、效率低下的问题愈发显得突出。为解决上述问题,本文对作者所在机构伦理委员会委员、研究者及试验申办方进行调查;对国内及美国开展多中心临床试验伦理审查情况进行调研和文献分析;比较借鉴美国开展多中心临床试验伦理审查的经验,结合本机构多年的实践,提出在国内构建一个能够平衡效率与质量的,包含中心、联盟、协作伦理审查等模式的伦理审查机制及平台的初步设想。该设想对现行的多中心临床试验伦理审查体系从政策、监管部门、机构伦理委员会建设及审查模式等方面提出了改革建议。

In recent years,multi-center clinical drug trials undertaken by Chinese medical institutions continue to increase,but many ethical reviews of them were carried out differently in different institutions,and have inconsistent quality and low efficiency.To improve the efficiency and quality of these ethical reviews,interviews and discussions were held with authors＇ Institutional Review Board（IRB） members,principal researchers and sponsors.Literature review was conducted to compare the ways of ethical reviews Chinese IRBs and their counterparts from the Unite States carried out.Combining the experience from the American ethical review system with the practice of the authors＇ and some others institution,a preliminary idea was expected which constructs a new framework of ethical review mechanism and a platform balances efficiency and quality.This framework includes different reforms in policy making,regulator system,construction of IRBs and review mechanism.