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临床试验的对象是活生生的人体,在许多方面有别于尸体实验、动物实验、计算机模拟试验等生物医学领域中的常用研究方法,并可能产生医学科学以外的伦理的、法律的、经济的、社会的等方面的问题。因此,对临床试验的妥善管理是摆在临床研究工作者、医院管理者面前不容回避的问题。要在《赫尔辛基宣言》基本原则的指导下,在国家相应法律、法规的规范下,积极地、严谨地、科学地开展必要的临床试验;要对临床试验的全过程切实加强管理
The object of clinical trials is a living human body, in many respects different from commonly used methods in biomedical fields such as cadaveric experiments, animal experiments, and computer simulation experiments, and may produce ethical, legal, and economical issues other than medical science. Social issues. Therefore, proper management of clinical trials is an issue that cannot be evaded by clinical researchers and hospital administrators. Under the guidance of the “Helsinki Declaration” basic principles, and under the corresponding national laws and regulations, we must actively, rigorously and scientifically carry out necessary clinical trials; we must strengthen the management of the whole process of clinical trials.