Ravinetto Raffaella
Public Health Department, Institute of Tropical Medicine Antwerp, Nationalestraat, 155, 2000 Antwerp, BELGIUM,.
Indian J Med Ethics. 2017 Oct-Dec;2(4):255-259. doi: 10.20529/IJME.2017.057.
The Guideline for Good Clinical Practice (GCP) of the International Conference of Harmonisation (ICH) is an international standard for the ethical and scientific quality of the designing, conducting, recording and reporting of trials that involve the participation of human subjects. Today, most regulators and funding agencies follow the ICH guidelines. These were drawn up by a small number of regulatory agencies and drug companies from high-income countries and do not pay sufficient heed to the problematic aspects of clinical trials in the low- and middle-income countries. A recent process of revision of the ICH GCP, which focused mainly on improving the use of technology and quality systems in clinical trials, did not remedy the pre-existing divide between the guideline, ethics and the challenges of globalised clinical research. It is not clear whether another, newly announced "renovation" of the ICHGCP (a "reflection paper" was open for public comment until March 11, 2017) will succeed in addressing this divide.
国际协调会议（ICH）的《药物临床试验质量管理规范》（GCP）是涉及人类受试者参与的试验设计、实施、记录和报告的伦理与科学质量的国际标准。如今，大多数监管机构和资助机构都遵循ICH指南。这些指南由少数高收入国家的监管机构和制药公司制定，没有充分关注低收入和中等收入国家临床试验中存在问题的方面。最近对ICH GCP的修订过程主要集中在改善临床试验中技术和质量体系的使用，但并未弥补该指南、伦理与全球化临床研究挑战之间原有的差距。目前尚不清楚ICH GCP新宣布的另一次“革新”（一份“反思文件”在2017年3月11日前公开征求意见）是否能成功弥合这一差距。
