In this questionnaire survey of physicians at KUH, most respondents were currently participating in clinical research and felt that clinical research was necessary. As compared to physicians participating in clinical research, smaller proportions of physicians had formal training in clinical research. The majority reported a need to acquire concepts and skills regarding clinical research, especially those related to statistics. Both previous participation in and prospective participation in clinical research were positively associated with current participation in clinical research, suggesting that physicians who were accustomed to clinical research were participating in and would participate in clinical research.
Our findings indicate that the contention that "doctors (in Japan) simply don't want to take part in clinical trials"[11
] is a misunderstanding. Indeed, our results indicate that if an adequate trial infrastructure is present, Japanese physicians are eager to conduct clinical research.
KUH is an important research center in Japan, and this likely explains why the rates of participation in and acknowledgement of the importance of clinical research were high among respondents. Studies have reported a wide range in the percentage of physicians participating in clinical research, from 13% to 90% [12
]. In a questionnaire survey at Tokushima University Hospital[8
], 61% of faculty had contributed to IND application trials and 58% of those wanted to participate in IND application trials, whereas in our survey at KUH, 89% of faculty reported past participation in clinical research. The difference in participation rates could be the result of different criteria of clinical research in the questionnaire. As mentioned above, many non-notified trials are carried out at KUH and other hospitals. Perhaps the rate of participation was high because, with the exception of notified trials, physicians in Japan are able to initiate clinical research with only minimal ethical oversight.
In the present study, the difficulties that physicians faced in conducting clinical research are similar to those noted in previous studies [14
]. Paperwork was cited as a major hurdle, even though the limited number of regulatory obstacles in Japan would be expected to lessen paperwork demands. Perhaps because physicians have a low opinion of the necessity for preparing and managing study documents, they perceive extra paperwork as onerous. Therefore, we suggest that a clinical support center should be available to provide initial advice and support regarding the production and design of documents, thereby establishing good practice. Lack of time was also reported as a major hurdle. Most physicians in university hospitals in Japan are involved in both patient care and research on molecular and cellular biology including experiments with animals. Because researchers could study molecular and cellular biology on a smaller budget than clinical research, which is the evaluation of new treatment involving human subjects, they studied it since it was introduced to Japan. As a result, there are few highly skilled clinical researchers in Japan and opportunities to learn the principles and methodology of clinical research are limited for young Japanese physicians.
Physicians who are familiar with clinical research are able to conduct clinical research more easily than those who are not, as they know the guidelines and laws necessary for conducting clinical research and can use their pre-existing network of experienced research collaborators [17
]. In addition, physicians who have completed clinical trials can obtain funding more easily than those who have not; however, they gain no special treatment or financial incentives [11
]. As the majority of physicians indicated that obtaining a better understanding of disease was the greatest benefit of conducting clinical research, the pleasure of discovery would appear to have more than repaid them for their efforts.
In our model with respect to current participation in clinical research, the previous training in clinical research was not found to be a significant factor. As various training providers were reported in this questionnaire, the programs and the length of these training courses should be variable. Universities or university hospitals should develop a standardized training program on clinical research that physicians can learn essential knowledge before they initiate such research.
The current study did have some limitations. The most significant of these is that the clinical research referred to in this survey comprised a variety of research types, ranging from epidemiological and observational studies to clinical trials, including IND application trials. Nevertheless, the research support section that serves the university hospital assists with a variety of clinical research designs, and a commonality of needs among physicians was demonstrated in our survey. Another limitation was that the response rate was much higher among faculty than among resident, which may influence the final logistic regression analysis. In addition, this survey took place at a single institution, so the possibility for generalization is limited. However, the difficulties indicated by respondents were quite consistent with those of prior reports. Moreover, an ongoing international collaboration project is attempting to compare the status and attitudes of physicians, and to seek strategies to promote clinical research. The results of this study have contributed much to the refinement and modification of the questionnaire used for the international attitude study. We aim to identify unique and universal problems regarding academic clinical research, and to submit them to academic societies and governing bodies in order to improve the situation. In addition, after completion of our questionnaire survey, Ethical Guidelines for Clinical Studies were just revised and enacted in April 2009. Under the revised guidelines, investigators are now required to register their trials at a public trial registry, to obtain insurance for trial subjects, and to have adequate training in clinical research. Concern for the welfare of trial subjects may have increased, but this may create another barrier to perform clinical research by requesting more paperwork and more funding for insurance for trial subjects.