Terminology

Clinical trial study

A therapeutically-effective medicine must be approved by the Health, Labor and Welfare Ministry in advance to use it at medical institutions and sell it at pharmacies. It is necessary to confirm the safety and efficacy of a medicine by administering it to patients to obtain approval for the same from the ministry.
This test, combined with treatment, is called a “clinical trial study”. A clinical trial study must be carried out according to the Good Clinical Research Practice (GCP) as specified by the Health, Labor and Welfare Ministry.

Post-marketing clinical study

This study is performed for medicines already approved by the Health, Labor and Welfare Ministry to collect information on their use and confirm their efficacy and safety, which cannot be done via a clinical trial study because medicines can be tested only on a limited number of patients in such studies.

Phases of test (Tests for Phases I, II and III)

Clinical tests including a clinical trial study, which are conducted to check whether new medicines can be used as standard therapy, are performed in the following three phases:

Phase I test

This test is conducted to check the safety and side effects of a medicine. At the same time, the test checks the change in concentration of the medicine in blood (pharmacokinetics) and its absorption and egestion. The test is conducted for a new medicine and combination of medicines in their initial state.

Phase II test

The medicine is administered to patients within the quantity limit, the safety of which has been confirmed in the Phase I test, to study its efficacy and safety (side effects).

Phase III test

This test is conducted to study whether the new therapy (study therapy) checked in Phase I and II tests is superior to conventional standard therapies. In many cases, doctors and patients cannot decide whether to use the standard therapy or the new therapy, and therefore a random decision is made as to which therapy to use.

Research plan (protocol)

This is a plan document for clinical trial studies, etc., and a clinical study is performed according to the research plan. It describes the purpose of the clinical trial study in detail, conditions for the subject patients and the research method. The ethical review board checks the research plan to see whether it is acceptable scientifically and ethically, and any clinical trial study rejected by the board cannot be performed.

Informed consent sheet

For patients who participate in a clinical trial study, etc., we will explain the purpose and method of the research to them, and its expected merits and demerits with a document (informed consent sheet).
If patients agree to participate in a clinical trial study, etc. after the explanation, they sign the informed consent sheet.

Clinical Test Conducted by the Shizuoka Cancer Center

Clinical Test Conducted by the Shizuoka Cancer Center