关键词: 随机化, 医学伦理学, 外科临床研究设计

Abstract:

Employment of randomization and his reflection of ethics in surgical clinical research design YANG Zhen.Department of Surgery,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology,Wuhan430030，China Abstract In this paper, some confliction between randomization and medical ethics in surgical clinical research design were analysed. Owing to randomization may interfere with patient’s autonomy and limit surgeons’ freedom, so randomization could be difficult to carry out in surgical clinical research. It is most important that the medical needs of the patients must always be given priority, therefore, surgeons should make good communication with patients. A few alternative design could be employed in surgical clinical research, for example the adaptive design、objective performance criteria (OPC)、sequential design and non-randomized controlled design.

Key words: randomization, medical ethics, surgical clinical research design