【摘要】 Ⅰ期临床试验是药物临床研究的起始阶段,是整个药物研发链中十分重要的一环。Ⅰ期临床试验通常是以健康受试者为主要研究对象的单中心临床研究,健康受试者不但不能获得疾病治疗的益处,还常常需要承受高剂量试验药物所引起的不良反应。对Ⅰ期临床试验受试者的保护应贯穿在试验的整个过程中,从方案设计、伦理审查和知情同意、保险和研究协议、身份识别和个人信息保护、临床观察及安全性评价等方面进行严格管理。更多还原

【Abstract】 As a very important part of the whole drug development chain, phase Ⅰ clinical trial is the initial stage of drug clinical research. Healthy subjects are usually recruited by a single site for a special phaseⅠ clinical study. The healthy subjects could not obtain treatment benefits as patients, instead they often endure the adverse reactions caused by the high dose of investigational medicinal product. The protection for phase Ⅰclinical trial subjects should be run through the whole process from protocol design, ethics review and informed consent, insurance and study contract, identity recognition and personal information protection, clinical observation and safety evaluation, all of which need to be strictly managed.更多还原