薬理と治療

Abstract

Background：Electronic Data Capture（EDC）system has been used to collect information in clinical trials. The proportion of trials using EDC in Japan was established to be lower than that in foreign countries. In 2007, we found the coverage of EDC was 34％ in pharmaceutical companies of Japan. Some researches pointed out issues for introducing EDC, but follow－up surveys about EDC were scarcely reported in Japan. Objectives：To make the issues clear by comparing the results of research about the current usage situation of EDC with that in 2007. Methods：Structured questionnaire was delivered targeting both data management section in clinical development division and post marketing surveillance division of member companies of Japanese Pharmaceutical Manufacturers Association. Results：Among 102 respondents obtained, 56（55％）sections use EDC；the proportion was about 20 percent higher than that of the previous research in 2007. Out of 60 sections which have used EDC, 26（43％）sections have considered the case report form should be paper－based in the trials using EDC. One of the most important promoting factors for EDC was“to make EDC system cheaper”. Conclusions：We found the whole EDC coverage was much higher than the previous research, and that the most challengeable barrier was that EDC systems were relatively expensive. We revealed that the issues for introducing EDC at medical institutions were lack of infrastructure and security issue.