药物临床试验受试者招募的主要问题及伦理审查要点

Main Problems and Ethical Review Points of Subject Recruitment in Drug Clinical Trials

药物临床试验需要招募适合的受试者验证新药的安全性和有效性,受试者招募是整个药物临床试验过程中非常重要和富有挑战性的环节,甚至直接影响试验的进度和最终结果。医学伦理委员会应该充分发挥伦理审查的重要职能,从科学性和伦理学角度,对受试者招募的整个过程进行认真审查,做好受试者健康和权益的保护工作。通过探讨受试者招募的基本原则、招募过程中存在的主要问题和伦理审查的重点内容,为规范受试者招募、保护受试者权益、促进药物临床试验高效和高质量地完成提供科学参考和建议。

Drug clinical trials need to recruit suitable subjects to verify the safety and effectiveness of new drugs.Subject recruitment is a very important and challenging link in the whole process of drug clinical trials,and even directly affects the progress and final results of the trials.The medical ethics committee should give full play to the important function of ethical review,carefully review the whole process of subject recruitment from the perspective of science and ethics,and do a good job in the protection of the health and rights of subjects.This paper mainly discussed the basic principles of subject recruitment,the main problems existing in the recruitment process and the key contents of ethical review,so as to provide scientific references and suggestions for standardizing subject recruitment,protecting the rights and interests of subjects,and promoting the efficient and high-quality completion of drug clinical trials.