薬理と治療

Abstract

In recent years, quality control and reliability of clinical research have been required, and it has become difficult for investigators to carry out clinical research appropriately. Therefore, investigators need to be supported by clinical research supporters more than ever. In order to clarify the problems in supporting for the quality control of clinical research, we conducted a questionnaire survey about their clinical research support at their institute and interviewed what is needed for quality control and ensuring of reliability in clinical research. The results of the questionnaire survey suggested that those who have supported clinical research for more than one year are aware of the problem of quality control and reliability of clinical research, which is the purpose of this research. Therefore, we interviewed eight supporters with more than one year of clinical research support experience at university hospitals in the four prefectures of Shikoku. And it was elucidated that there are currently insufficient resources for investigators and supporters, support systems, and supports to manage the quality of clinical research and ensure credibility. It is important to build the system conducting clinical research by making up for these insufficient points, but it is difficult in reality. It is necessary to consider the support system based on the quality of research, and it is desirable to build a system that can be implemented even when resources are limited.