Gan to kagaku ryoho. Cancer & chemotherapy
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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.
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Gan To Kagaku Ryoho · Mar 1998
Randomized Controlled Trial Comparative Study Clinical Trial[Effect of granisetron in preventing emesis due to anti-cancer drug (CDDP) administration pulmo-mediastinal malignancies--comparison of simultaneous infusion with the conventional method of administration].
For patients with pulmo-mediastinal malignancies, the antimetic effect of granisetron was studied in the following two ways. Firstly in the standard method, 40 micrograms/kg of granisetron was infused for 30 minutes, 30 minutes before CDDP infusion. ⋯ The non-effective rates were 18.2% and 15.8%, respectively. Although the results were not statistically significant, the simultaneous method is easier to perform and it seems to confer a slightly better clinical outcome than the conventional method.
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Gan To Kagaku Ryoho · Mar 1998
Case Reports[A case of multiple liver metastasis of gastric cancer responding to hepatic arterial infusion chronotherapy].
A 64-year-old man underwent total gastrectomy and placement of the hepatic arterial catheter for advanced gastric cancer with multiple liver metastasis. After the operation, repeated hepatic arterial infusion chemotherapy was performed. ⋯ A total of 13 courses of this chemotherapy diminished liver metastasis. During this therapy, the patient's condition was good, with no experience of nausea or leukopenia.
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Gan To Kagaku Ryoho · Feb 1998
[Development of an anticancer drug in Japan based on a new clinical trial system].
According to the revision of Pharmaceutical Affairs Law in 1996, the GCP has been enacted into the law. Next year the new GCP was established based on the ICH-GCP and it has been active since April, 1997. Though the new GCP makes it possible for the regulatory authorities (Japan, the United States and European Union) to accept clinical trial data mutually, the circumstances of clinical trial in Japan have been required big changes. ⋯ At the first time, in this article are described the process of both the revision of Japanese pharmaceutical law and the establishment of the new Japanese GCP. The second, the characteristics of the new Japanese GCP especially about the roles and responsibilities of investigators are discussed. Furthermore approaches of the US FDA for new anticancer drugs development are also described.