Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Apr 1998
[Development of anti-cancer drugs under new renewed GCP--from the viewpoint of drug development company developer].
During the past 7 years since the enforcement of Japan's first GCP in October 1990, various standards and guidelines have been introduced in Japan. On the other hand, the harmonization of GCP has been the subject of major discussion at ICH in order to allow the mutual acceptance of clinical data from different countries. In order to further improve the reliability and consistency of clinical data and the ethics of clinical trials in Japan, the new GCP was enforced in April 1997. ⋯ Before the full enforcement of the new GCP, we, as sponsors of clinical trials, carried out a survey of the current status of clinical trials centering on the reactions of medical institutions to the new GCP, future of clinical trials on anti-cancer drugs in Japan, and differences in time from clinical trials to registration in Japan, the United State and Europe. We sent a questionnaire by facsimile to 21 pharmaceutical companies which have developed or are developing anti-cancer drugs and obtained replies from 20 companies (95%) from August 25 to 30, 1997. This paper reports issues concerning clinical trials on anti-cancer drugs based on the results of our survey.
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The new Japanese GCP enacted on the basis of ICH-GCP adopts more clear concepts of quality assurance for a clinical trial. This article briefly describes its principles. ⋯ Further, this addresses the required reorganization which the sponsor should strive for as well as the sponsor's requests to participating medical institutions such as adoption of a "study coordinator". To improve the quality of a clinical trial, it would be necessary to refer not only to GCP but also to other current guidelines such as those harmonized at the ICH.
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In 1997, a new GCP has taken effect by the Ministry of Health and Welfare, Japan, and will be enforced as of April, 1998. The GCP regulates the method of clinical trials in the light of ethics and science. The New GCP requires written informed consent, enforcement of the responsibility of the client and so on.