Clinical trial center

Greetings/Overview

Greetings

Today, medical goods and medical equipment take a fundamental part in providing medical care. Thousands of patients are waiting for more effective and safe medicines and medical equipment and arrival of new medicines that can cure the diseases that are impossible to be treated now. It takes a very long period of time to make new developed medicines and medical equipment to available to many people. This is because they are tested in many examinations such as experimentation in animals and clinical trial ,then put under stringent screening performed by Ministry of Health, Labor and Welfare for its validity 8effectiveness) and safety(adverse effect).

Generally, ”clinical trial” indicates clinical investigation performed on human beings which is conducted in the course of developing medical goods with the aim of gaining approval from Ministry of Health, Labor and Welfare. There is a strict specified rule called GCP(Good Clinical Research Practice) in “clinic trial” and according to which, the clinic trials are conducted. “Clinical trial” has criteria in order to properly examine the validity and safeness of medical goods. This is to protect the right and safety of patients involved in the clinical trials, those who meet the criteria for the medical trial are first receive explanations about the content of the trial, then, asked to participate in the trial only if they agree.

Clinical Trial Center was established in our hospital in November, 2004. It has been converted into an independent service as CRC(Clinical Research Coordinator) by pharmacists, nurses and clinical laboratory technologist etc. they have been providing various services related to “clinical testing” such as support for patients, doctors and management of investigational new drug.
In the aim of providing new medical goods and medical equipment for patients who are longing for them, we would like to enhance our service, to create an environment where the whole hospital staff are involved in “clinical trial” and spread enlightenment in general citizen.

Director of Clinical Trial Center

Clinical Trial means・・・

“Clinical trial” is a clinical investigation in which we gain corporation from patients to check the “effectiveness” and “safeness of new drugs, in order to obtain approval from Ministry of Health, Labor and Welfare.

Before a new drug becomes approved it has to undergo the steps below.

Basic research Find candidate drugs
Non-clinical trial Apply candidate drugs to animals and check its “effectiveness” and “safeness”
Clinical trial
Phase I study
we gain corporation from people who are healthy and check the safeness, absorption and egestion of the medical drug on them.
Phase II study
we gain corporation from a few patients and check the “safeness”, “effectiveness” and “appropriate quantity and method of usage” on them.
Phase III study
we gain corporation from many patients and check the safeness of the medical drug, also compare its effectiveness with the medicine and placebo (a medicine containing no active substance) which are commercially available.
Application for approval  
Approval  
Phase IV study Collect more information after they’ve become commercially available

For people who request for Medical trial

Please contact us at Clinical Trial Center of this hospital.
Contact address Okinawa Tokushukai Clinical Trial Center
Telephone: 046-223-3605(direct number)
E-mail tiken@shonan-atsugi.jp
With Regarding to our acceptance of medical trials, they are discussed in Tokushukai Group Cooperative Institutional Review Board, administered by Mirai Iryo Research Center Inc.
Mirai Iryo Research Center