title: Clinical trials for drug approval: a pilot study of the view of doctors at Tokushima University Hospital.
abstract: 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%) and 62 (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.
authors.affiliation: Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yanagawa
authors.forename: Masako
authors.initials: M
authors.lastname: Nishiya
authors.forename: Toshiko
authors.initials: T
authors.lastname: Miyamoto
authors.forename: Michiyo
authors.initials: M
authors.lastname: Shikishima
authors.forename: Mitsuko
authors.initials: M
authors.lastname: Imura
authors.forename: Rika
authors.initials: R
authors.lastname: Nakanishi
authors.forename: Kazuyo
authors.initials: K
authors.lastname: Ariuchi
authors.forename: Akiyo
authors.initials: A
authors.lastname: Akaishi
authors.forename: Shigemi
authors.initials: S
authors.lastname: Takai
authors.forename: Shinji
authors.initials: S
authors.lastname: Abe
authors.forename: Masatoshi
authors.initials: M
authors.lastname: Kisyuku
authors.forename: Chieko
authors.initials: C
authors.lastname: Kageyama
authors.forename: Chiho
authors.initials: C
authors.lastname: Sato
authors.forename: Makiko
authors.initials: M
authors.lastname: Yamagami
authors.forename: Noriko
authors.initials: N
authors.lastname: Urakawa
authors.forename: Saburo
authors.initials: S
authors.lastname: Sone
authors.forename: Minoru
authors.initials: M
authors.lastname: Irahara
mesh_terms: D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000639:trends*; D017277:Drug Approval; D007722:Health Knowledge, Attitudes, Practice; D006785:Hospitals, University; D006801:Humans; D007258:Informed Consent; D007400:Interprofessional Relations; D007564:Japan; D010819:Physician's Role; D010865:Pilot Projects; D011795:Surveys and Questionnaires; D016312:Treatment Refusal; D016526:Workload