Shimada Y
Department of Medical Oncology, National Cancer Center Hospital, Japan.
Gan To Kagaku Ryoho. 1996 Jan;23(2):226-30.
Informed consent in phase I trials involves very difficult problems related to experimental factors of the phase I trial, a toxicity study conducted in human cancer patients. However, this is the first clinical step in new drug development, and patients must participate in phase I only when there is full disclosure of correct trial information. Disclosure should include the purpose of the trial, the procedure, and the risk/benefits related to the trial. Informing the patient of the cancer diagnosis and the extent of disease is also necessary before entry into a phase I trial. Although phase I trials are conducted with the precious contribution of patients, it is important that informed consent should not become a type of legal contract. Informed consent in phase I trials is an essential process, just like a roundtable discussion of patient and physician before fighting an incurable cancer.
I期临床试验中的知情同意涉及与I期试验的实验因素相关的非常棘手的问题，I期试验是在人类癌症患者中进行的毒性研究。然而，这是新药开发的首个临床步骤，只有在充分披露正确的试验信息时，患者才能参与I期试验。披露内容应包括试验目的、程序以及与试验相关的风险/益处。在进入I期试验之前，告知患者癌症诊断情况和疾病程度也是必要的。尽管I期试验是在患者的宝贵贡献下进行的，但重要的是，知情同意不应成为一种法律契约。I期临床试验中的知情同意是一个必不可少的过程，就如同在对抗无法治愈的癌症之前患者与医生进行的一次圆桌讨论。
