民族衛生
Online ISSN : 1882-868X
Print ISSN : 0368-9395
ISSN-L : 0368-9395
無作為化臨床試験の被験者になることの受容性
―本音と建前および未経験質問票項目に対する観念的回答を鑑みて―
杉田 稔清水 勇人宮川 路子大田 原由美伊津 野孝
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2006 年 72 巻 2 号 p. 70-80

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Conducting randomized clinical trial (RCT), which is indispensable for developing new treatments, requires participation of study subjects. We investigated the receptivity of participating as study subjects using questionnaire. A self-report questionnaire survey of 401(264 males, 137 females) teaching and non-teaching staff members in non-medical, non-dental, or non-pharmaceutical schools of a university and its affiliate schools located in the Tokyo metropolitan area was conducted in 1995. We obtained the receptivity rates of participating as RCT study subjects and compared the values between the various subgroups. The receptive rate of participation as RCT study subjects was more than 50% from the questionnaire survey in the present study. It is, however, difficult to conclude that the value shows true status in Japan, because most Japanese reply from their true intention (honne) on one occasion but from stated intention (tatemae) on another. This derives from the long history and ingrained culture of Japan. It is not reasonable to assume that many Japanese will agree to participate as RCT study subjects from their true intention. Study subjects of questionnaire surveys reply to unexperienced items as concepts as opposed to items that have actually been experienced. It is reasonable to assume that the most respondents to the present study have not experienced participating as RCT study subjects because RCTs participants are much smaller in number than the general population. In the present study, the absolute RCT receptive rates must contain a large bias, while relative comparisons between the RCT receptive rates of subgroups may be reliable. Therefore, it may be difficult to conduct RCTs in Japan in the future.

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