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.

A survey of attitudes toward clinical research among physicians at Kyoto University Hospital

“…To prepare the questionnaire, we modified and added questions to a questionnaire from a similar study conducted in Tokushima University Hospital [8]. …”

Nurse awareness of clinical research: a survey in a Japanese University Hospital

“…We have already reported physicians’ view on registration trials [6], and considered understanding clinical nurses’ awareness of research, including “local” situations, may contribute to the establishment of a clinical research infrastructure. Therefore, we focused on clinical nurses and used questionnaires to survey their status at Tokushima University Hospital.…”

The Views of Doctors on Registration Trials in a Japanese Rural Area: A Survey of Medical Institutions Registered to the Tokushima Network for Clinical Trials

“…Nevertheless, our previous studies revealed that doctors' views regarding registration trials at Tokushima University Hospital have remained conventional. 4 A clear understanding of the attitude of doctors at networking medical institutions, therefore, may contribute to the establishment of an effective network strategy, and improve the understanding and organization of clinical trials in regional areas. The present survey revealed that 48% of the doctors questioned were familiar with registration trials and their attitude towards participating as investigators in these trials was favourable (87% felt positive).…”

“…In our previous studies that were conducted in 2000 and 2004 at Tokushima University Hospital, we reported that more doctors were familiar with registration trials (66% in 2004 and 84% in 2000) but fewer felt favourable towards participating as investigators (58% in 2004 and in 66% in 2000). 4 Considering that the doctors who responded to the …”

“…4 The questionnaire started by examining general attitudes towards registration trials on a four-point scale (strongly agree, agree, disagree and strongly disagree). This was followed by practical questions, such as the benefits to doctors of involvement in registration trials and the difficulties regarding participation as investigators.…”