Gan to kagaku ryoho. Cancer & chemotherapy
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Development of new anticancer drugs is essential to improve the response and survival of cancer patients. Nationally supported organizations have a key role in conducting very experimental expensive and ethical clinical trials. In the U. ⋯ Their team consists of younger physicians, research nurses, data managers, pharmacologists, technicians and the primary investigator under strong leadership. Recently, international harmonization of the U. S., -Europe and Japan is postulated politically, However, we have to recognize that this interrelationship has another meaning, that of "international competition and comparison" with each other in the field of new drug development.
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Gan To Kagaku Ryoho · Oct 1994
Review[Current status and issues in clinical trials of anticancer agents].
NDA filing and government approval for drug manufacturing marketing rights are processes based on collaboration among the concerned parties; a drug manufacturer (or importer), a medical institution and a government agency. However, quality guidelines are necessary for a scientific, ethical and economically efficient clinical study to be conducted. ⋯ Among them we discuss the following items for revision of the Guidelines and made suggestions and opinions from the manufacturers' point of view: Phase I: Number of institutions for clinical study, determination of MTD and study design. Phase II: Introduction of foreign data, late phase II study for plural numbers of indications at time of NDA filing and evidence of usefulness in concurrent therapy.