中国医学伦理学2024，Vol.37Issue(5)：556-563,8.DOI:10.12026/j.issn.1001-8565.2024.05.09
以患者为中心的临床试验的伦理审查挑战
Challenges of ethical review in patient-centered clinical trials
摘要
Abstract
Patient-centered clinical trials refer to clinical trials that take participant'needs as the starting point,regard participant as active participants,and take clinical values as the ultimate goals.This concept has become the core guiding ideology of current pharmaceutical research and development,and the model of the patient-centered clinical trial will gradually become the mainstream model of pharmaceutical research and development.Patient-centered clinical trials in China have challenges such as difficulty in changing the way of trial thinking and quality control,increased difficulty in participant'privacy protection,lack of training for all research parties,and unfair recruitment of research participants.Then suggestions were proposed for patient-centered clinical trials in China from three aspects,including relevant departments provide more policy support,sponsors and relevant third parties timely transform ideas of research and development,as well as researchers and research participants strengthen awareness.This paper also put forward the key points of ethical review of patient-centered clinical trials from 8 aspects,including the trial design that incorporated preference information on patients and took into account the assessment of clinical outcomes,protection of the safety and rights of research participants,recruitment based on the needs of research participants,acceptable informed consent,the rationality of selection of decentralssed clinical trials elements,privacy protection of research participants,training and education of researchers and research participants,and compensation and indemnity of research participants,so as to standardize the ethics review of patient-centered clinical trials and ensure the quality of patient-centered clinical trials.关键词
以患者为中心/临床试验/伦理审查/隐私保护Key words
patient-centered/clinical trial/ethical review/privacy protection分类
医药卫生引用本文复制引用
张增瑞,周吉银..以患者为中心的临床试验的伦理审查挑战[J].中国医学伦理学,2024,37(5):556-563,8.基金项目
2022年西南医科大学社科重点项目"药物临床试验受试者保护体系的规范化研究"(2022SK001) （2022SK001）
2022陆军军医大学人文社会科学基金重点项目"我市涉及人的健康相关研究伦理治理的现状与对策研究"(2022XRW05) （2022XRW05）
