ID 110825
著者
楊河, 宏章 Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital 徳島大学 教育研究者総覧 KAKEN研究者をさがす
ニシヤ, マサコ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
ミヤモト, トシコ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
シキシマ, ミチヨ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
イムラ, ミツコ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
ナカニシ, リカ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
アリウチ, カズヨ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
アカイシ, アキヨ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
タカイ, シゲミ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
阿部, 真治 Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital 徳島大学 教育研究者総覧 KAKEN研究者をさがす
キシュク, マサトシ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
カゲヤマ, チエコ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
サトウ, チホ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
ヤマガミ, マキコ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
ウラカワ, ノリコ Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
曽根, 三郎 Institute of Health Biosciences, The University of Tokushima Graduate School 徳島大学 教育研究者総覧 KAKEN研究者をさがす
苛原, 稔 Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital 徳島大学 教育研究者総覧 KAKEN研究者をさがす
キーワード
doctors’ view
clinical trials
questionnaire
drug approval
資料タイプ
学術雑誌論文
抄録
The development of new and useful pharmaceutical drugs is essential in order to improve the quality of drug therapeutics. Clinical trials play a central role in drug development. Over time, the clinical trial infrastructure has improved and is now integrating the contribution of clinical research coordinators (CRC). Nevertheless, the attitude of doctors towards clinical trials still favors conventional/historical methodologies. In the present study, we explored the view of doctors towards clinical trials for drug development, in order to improve communication among participants, sponsors, and investigators. A questionnaire was designed for this pilot study. The questionnaire included general attitudes, difficult points, the benefit of doctors in participating as investigators, special attention requirements, and the expected role of CRC in clinical trials for drug approval. In addition, the appropriate use of the outpatient clinic was examined. The questionnaire was provided to doctors in each department of Tokushima University Hospital in 2000 and 2004. Because of the small number of subjects included in this pilot study, no statistical analysis is presented. A total of 89 (81%) and62 (56%) doctors among 110 responded to the survey in 2000 and 2004, respectively. Inquiries about the familiarity of the physicians with clinical trials for drug approval revealed that 84% in 2000 and 66% in 2004 were aware of such trials. The attitude towards participating as investigators in the clinical trials was favorable, with a response of 66% in 2000 and 58% in 2004. Patients’ refusal and the informed consent process were considered difficult areas by many doctors. Expected roles of CRC included activities based on the nurse’s specialty. Although many doctors agreed to take care of the study participants separately from the clinical practice, they lacked the time to do so. In spite of the doctors’ workload reduction by introduction of the CRC concept, their views regarding clinical trials for drug approval remain conventional. Further refinement in the support process by CRC should be considered in our hospital, and the views of the doctors should be investigated in a larger study, in order to promote clinical trials for drug approval in Japan.
掲載誌名
The journal of medical investigation : JMI
ISSN
13431420
cat書誌ID
AA11166929
53
3-4
開始ページ
292
終了ページ
296
並び順
292
発行日
2006-08
フルテキストファイル
言語
eng
著者版フラグ
出版社版
部局
病院
薬学系
医学系