In Japan, only clinical research related to investigational new drug trials must be notified to regulatory bodies, and this lack of a uniform standard for clinical research has caused a number of difficulties. The objective of this study was to assess the willingness of physicians to participate in clinical research and to identify effective methods to promote and enhance clinical research.
We conducted a cross-sectional survey by administrating questionnaires to physicians in 31 departments in Kyoto University Hospital from October through November 2007.
A total of 51.5% (310 of 602) of physicians completed the questionnaire. More than two-thirds of them reported currently participating in clinical research, and nearly all believed that clinical research is necessary for physicians. Less than 20% of respondents had specific training regarding clinical research, and most reported a need to acquire concepts and skills regarding clinical research, especially those related to statistics. "Paperwork was complicated and onerous" was the most frequently cited obstacle in conducting clinical research, followed by "few eligible patients" and "lack of time". Previous participation in and prospective participation in clinical research, previous writing a research protocol were positively associated with current participation in clinical research.
Physicians in university hospitals need more training regarding clinical research, particularly in biostatistics. They also require administrative assistance. Our findings indicate that the quality of clinical research could be improved if training in clinical research methodology and biostatistics were provided, and if greater assistance in the preparation of study documents requested by the institutional Independent Ethics Committee were available.