Open AccessHow do we improve the quality of clinical trials in Japan? The role of the medical doctor
Author(s) -
Mano Toshiki,
Alaya Fumiko
Publication year - 1998
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/(sici)1099-1786(199806)3:2<71::aid-qaj61>3.0.co;2-y
Subject(s) - clinical trial , quality (philosophy) , good clinical practice , medicine , medical device , clinical practice , alternative medicine , business , family medicine , pathology , philosophy , epistemology , biomedical engineering
In recent years, a lot of focus has been on the quality of clinical trials in Japan. The implementation of the new Good Clinical Practice (GCP), harmonized with international standards, has prompted drug companies to assure the quality of clinical trials more strictly than before. Another point to be mentioned is the impact from the medical reform. It is not only the pharmaceutical companies that have to think about the efficiency of medical treatment, but also medical doctors. In this report, one of the changes occurring after new GCP implementation, the role of medical doctors, will be discussed. Copyright © 1998 John Wiley & Sons, Ltd.