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[癌症患者临床试验实施中的问题]

[Problems in conducting clinical trials for cancer patients].

作者信息

Kondo M

机构信息

Dept. of Radiology, Keio University School of Medicine, Tokyo, Japan.

出版信息

Gan To Kagaku Ryoho. 1996 Jan;23(2):151-5.

PMID:8611042
Abstract

There are many problems and difficulties in conducting clinical trials for cancer patients. Firstly, the public does not understand well the concept of clinical trials. They often can't distinguish clinical trials for comparing two treatment methods from ones for developing new chemotherapeutic agents. Secondly, clinical trials per se can hardly fulfill the necessary conditions. At least four conditions are necessary to allow clinical trials for cancer patients: (1) the possibility of improved survival by the new methods; (2) A necessity to conduct the clinical trials; (3) the possibility of conducting clinical trials; and (4) the permissibility of conducting said trials. However, none of these conditions are fulfilled. The reasons why clinical trials are not allowed in the field of cancer treatment are discussed.

摘要

对癌症患者进行临床试验存在许多问题和困难。首先,公众对临床试验的概念了解不足。他们常常无法区分比较两种治疗方法的临床试验和开发新化疗药物的临床试验。其次,临床试验本身很难满足必要条件。允许对癌症患者进行临床试验至少需要四个条件:(1)新方法有提高生存率的可能性;(2)有进行临床试验的必要性;(3)有进行临床试验的可能性;(4)进行上述试验的可允许性。然而,这些条件无一得到满足。本文讨论了癌症治疗领域不允许进行临床试验的原因。

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