新 GCP 下の臨床試験における服薬コンプライアンスに関する調査

フォーマット:

論文

責任表示:

古川, 裕之 ; 陶山, 和明 ; 河原, 昌美 ; 石崎, 純子 ; 松嶋, 由紀子 ; 長田, 幸恵 ; 松田, 静枝 ; 清水, 栄 ; 宮本, 謙一

言語:

日本語

出版情報:

日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics, 2001-01-01

著者名:

古川, 裕之

陶山, 和明

河原, 昌美

石崎, 純子

松嶋, 由紀子

長田, 幸恵

松田, 静枝

清水, 栄

宮本, 謙一

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掲載情報:

臨床薬理 = Japanese journal of clinical pharmacology

ISSN:

0388-1601      

巻:

32

通号:

1

開始ページ:

35

終了ページ:

42

バージョン:

publisher

概要:

To attain good medication compliance is the major premise in well-controlled clinical trials. We conducted a questionnaire survey on 40 clinical investigators, 25 sponsors and 20 trial subjects during Oct.-Dec. 1998 to investigate the correlation among actual circumstances of medication compliance in trial subjects and the evaluation of medication compliance by clinical investigators and sponsors, and to determine effective measures to improve … medication compliance. Whereas almost all clinical investigators and sponsors evaluated or expected over 70% of medication compliance, the trial subjects answered over 90%. The clinical investigators (95%) and the sponsors (96%) thought in actuality that the primary means to maintain good compliance was for the clinical investigator to individually interview the trial subjects. The sponsors proposed possible adoption of clinical research coordinator's (CRC) support, a specific dispenser device or container, the use of medication diary, etc. However, only a few beneficial medication devices and medication diaries have been provided by the sponsors to date. This survey suggests that the medicine dispenser device and the interview by CRC are very effective to attain good medication compliance. 続きを見る

URL:

http://hdl.handle.net/2297/18234