Arano Ichiro, Imaeda Takayuki
Pfizer Japan Inc., 3-22-7 Yoyogi, Shibuya-ku, Tokyo 151-8589, Japan.
Nihon Shinkei Seishin Yakurigaku Zasshi. 2011 Aug;31(4):181-6.
It has recently become possible to conduct placebo-controlled clinical studies in Japan. However, worldwide, there has been much discussion of the problems in placebo-controlled studies, such as the fact that the increase in the placebo response in clinical studies in depression increases the risk of failed studies and the number of patients that need to be enrolled. Japan has been participating in more multinational studies aimed at obtaining simultaneous worldwide approval. This paper discusses an overview of the development of antidepressants and examples of research that has been conducted on the placebo response, and describes the controversy regarding the designs of future studies as well as the issues involved in Japanese participation in multinational studies.
最近在日本开展安慰剂对照临床研究已成为可能。然而，在全球范围内，对于安慰剂对照研究中的问题存在诸多讨论，比如抑郁症临床研究中安慰剂反应的增加会提高研究失败的风险以及所需纳入患者的数量。日本一直在参与更多旨在获得全球同步批准的跨国研究。本文讨论了抗抑郁药的发展概况以及关于安慰剂反应所开展研究的实例，并描述了未来研究设计方面的争议以及日本参与跨国研究中所涉及的问题。
