ID 110825
Author
Yanagawa, Hiroaki Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital Tokushima University Educator and Researcher Directory KAKEN Search Researchers
Nishiya, Masako Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Miyamoto, Toshiko Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Shikishima, Michiyo Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Imura, Mitsuko Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Nakanishi, Rika Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Ariuchi, Kazuyo Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Akaishi, Akiyo Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Takai, Shigemi Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Abe, Shinji Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital Tokushima University Educator and Researcher Directory KAKEN Search Researchers
Kisyuku, Masatoshi Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Kageyama, Chieko Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Sato, Chiho Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Yamagami, Makiko Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Urakawa, Noriko Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital
Sone, Saburo Institute of Health Biosciences, The University of Tokushima Graduate School Tokushima University Educator and Researcher Directory KAKEN Search Researchers
Irahara, Minoru Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital Tokushima University Educator and Researcher Directory KAKEN Search Researchers
Keywords
doctors’ view
clinical trials
questionnaire
drug approval
Content Type
Journal Article
Description
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.
Journal Title
The journal of medical investigation : JMI
ISSN
13431420
NCID
AA11166929
Volume
53
Issue
3-4
Start Page
292
End Page
296
Sort Key
292
Published Date
2006-08
FullText File
language
eng
TextVersion
Publisher
departments
University Hospital
Pharmaceutical Sciences
Medical Sciences