1. Rules of Clinical Trials
Clinical trials are conducted in compliance with the Pharmaceutical Affairs Law and GCP in order to protect participants and accurately identify "drug candidates
In order to protect the human rights and safety of participants in clinical trials to the maximum extent possible, and at the same time to accurately determine the efficacy and side effects of "drug candidates" using scientific methods, very strict rules have been established by the government.
Clinical trials are conducted under the following procedures and mechanisms in accordance with the rules of the "Standards for Conducting Clinical Trials on Drugs (GCP)" established by the Ministry of Health and Welfare based on the Pharmaceutical Affairs Law.
Notification of the details of the clinical trial to the government
The pharmaceutical company notifies the MHLW of the "clinical trial protocol" agreed upon by the physicians in charge of the clinical trial. The MHLW examines the contents of the protocol and issues instructions for changes if any problems are found.
The Clinical Trial Review Committee reviews the details of the clinical trial in advance
The Clinical Trial Review Committee examines whether the "clinical trial protocol" is designed to protect the human rights and welfare of patients participating in the clinical trial and to scientifically investigate the effects of the "drug candidate," whether the physicians conducting the clinical trial are appropriate, and whether the details of the clinical trial are properly explained to participating patients.
The Clinical Trial Review Committee must include members who do not specialize in medicine and who have no vested interest in the hospital. Hospitals that are requested to conduct a clinical trial by a pharmaceutical company must follow the instructions of this committee after its review.
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After the Ministry of Health and Welfare completes its investigation, the pharmaceutical company requests the hospital to conduct the clinical trial. The hospital requesting the clinical trial must
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Have adequate medical and laboratory facilities
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Have sufficient staff, including specialized doctors, pharmacists, nurses, etc.
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Have access to a committee to review the details of the clinical trial
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have access to immediate necessary treatment in the event of an emergency
Only patients who give consent are allowed to participate in the clinical trial
The purpose of the clinical trial, its methods, expected effects, anticipated side effects and other disadvantages, and treatment options if the patient does not participate in the clinical trial must be explained in writing and the patient's consent must be obtained in writing.
Serious side effects are reported to the government
Any previously unknown serious side effects that occur during a clinical trial are reported to the government by the pharmaceutical company that requested the trial, and the trial plan is revised as necessary to ensure the safety of the patients participating in the trial.
The pharmaceutical company confirms that the clinical trial is being conducted properly
The person in charge (monitor) at the pharmaceutical company that requested the clinical trial investigates the progress of the clinical trial and confirms that the trial is being conducted properly in accordance with the "protocol" and GCP regulations.