薬理と治療

Abstract

Background In Japan, clinical trials of investigational new drugs must be conducted in accordance with GCP as enforced by law;however, there is still no legislation regulating other clinical researches. This study aimed to survey public awareness of clinical researches, including this double standard, and to discover the best way to conduct clinical research in Japan. Methods We administered an Internet-based questionnaire to the general public in March 2013. Results Only 20.0% of the respondents understood“Clinical Research,”which tended to be understood less than“Clinical Trial of Investigational Drug.”In addition, 86.6% of the respondents were not aware of the difference between“Clinical Research” and “Clinical Trial of Investigational New Drug.”On the other hand, 68.6% of the respondents were aware of the double-standard issue. Furthermore, people are not inclined to participate or cooperate in clinical research, and they appear to be more reluctant to participate in clinical research than in clinical trials of investigational new drugs. There were significant differences in the interest in participation or cooperation in clinical research between the experience and understanding in clinical research. Conclusion More public education on clinical research is needed. The result of this survey indicates that it is important for further growth of clinical research to improve people’s understanding of clinical research. There is also room for improvement in the implementation of clinical research to foster greater understanding and appreciation in general.