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Ⅰ期临床试验是新药首次用于人体。尽管Ⅰ期临床试验中不良反应发生率较低,但仍然有一定比例的不良反应病例出现,甚至出现严重的不良反应,如果处理不当,将会给受试者、社会带来难以估量的伤害。必须清醒地认识到Ⅰ期临床试验是一个高风险的研究。本文将结合作者在国内药物临床试验检查工作中发现的问题,对Ⅰ期病房的监护条件、Ⅰ期临床试验的研究人员组成、试验医疗监护和抢救流程等提出建议,以保障Ⅰ期临床试验受试者的安全,保证Ⅰ期临床试验的顺利进行。
Phase I clinical trials are new drugs for the first time in the human body. Although the incidence of adverse reactions in Phase I clinical trials is relatively low, a certain proportion of adverse reactions still occur and even serious adverse reactions occur. If not handled properly, it will bring immeasurable harm to the subjects and society. It is imperative to be clearly aware that Phase I clinical trials are a high-risk study. This article will be combined with the problems found in the clinical drug testing work in the country, the first ward guardianship conditions, phase Ⅰ clinical trial researchers, experimental medical care and rescue process to make recommendations to protect Phase Ⅰ clinical trials by The safety of the trial, to ensure the successful phase Ⅰ clinical trials.