抗肿瘤药物临床试验的特点和医学伦理问题

Specialty and Related Medical Ethical Issues in Clinical Trials of Anticancer Drugs

抗肿瘤药物的研发离不开高质量的临床试验,与非抗肿瘤药物相比,其临床试验既有共性也有特殊性,其相关医学伦理问题也日益引起人们的重视。探讨并总结抗肿瘤药物临床试验的研究对象、受试者招募、知情同意、试验设计、疗效观察和安全性评价等主要内容的特点及相关医学伦理问题,为抗肿瘤药物临床试验更好地保护受试者,以及更加规范化地实施和长远发展提供科学依据和参考。

The research and development of new anticancer drugs rely on high quality clinical trials, which have both common but special characteristics compared with non-anticancer drugs, and their related medical ethical issues are getting more and more attention. This paper discusses and summarizes the specialty of study objects, subjects＇ recruitment, informed consent, experimental design, observation of therapeutic effect, security evaluation, and related medical ethical issues in clinical trials of anticancer drugs, in order to provide scientific basis and reference for protecting subjects better and get a more standardized long-term development of clinical trials about antieancer drugs.