Gan to kagaku ryoho. Cancer & chemotherapy
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The main purpose of the phase I clinical study is to define the tolerable doses in each various administration schedules depend upon by careful clinical observations and by pharmaco-kinetic, -dynamic studies. final goal of the phase I clinical study is to establish the safe, most reasonable administration schedules to perform further clinical studies, including phase II, III and possibly iv. In addition, it is quite reasonable to observe efficacy of the given agent if possible. The patients who are selected to receive the phase I clinical study should be fulfilled the followings: (1) Histological proof of malignancy; (2) No best available therapy regimen at present; (3) Maintain reasonably well organ functions which are suitable to observe side reactions (4) No hang-over reactions from previous therapy and; (5) Consent from patient himself or members of the family concerning the study. ⋯ The new agent which has enough reliable clinical date in the abroad, the clinical study in this country would be simplified. The phase I clinical study should be performed in the well-equipped institutions under the supervision of capable investigators. The guide line of phase I clinical study would be revised whenever it is necessary.
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Gan To Kagaku Ryoho · Mar 1984
[A tentative of guideline for phase III study and its problems in clinical aspect].
A draft of guideline for phase III study of anticancer drugs was presented, and its objective problems in practical aspect was discussed. The anticipated of phase III study is to evaluate the clinical usefulness of anticancer drug in terms of effectiveness and toxicity. ⋯ Considering the precision of study, the randomized controlled trial is most rational, but it includes some controversies in practical use and ethical aspect. On the other hand, non-randomized controlled trial includes some problems on comparability in relation to prognostic factors.