Clinical trial business

What is a clinical trial

Substances discovered from chemical synthesis, plants, soil fungi, marine organisms, etc. are predicted to be effective against diseases and safe for human use through test-tube experiments and animal experiments. Those that are tested are selected as “drug candidates”.In the final stage of development of this "drug candidate", it is necessary to examine the efficacy and safety in humans in cooperation with healthy people and patients.
The results obtained in this way are reviewed by the government, and drugs that are approved as necessary for the treatment of illness and safe to use become "medicine."
Human trials are generally called “clinical trials,” but clinical trials that use “candidate drugs” to gather results for government approval are particularly called “clinical trials.”Many clinical trials proceed carefully in three phases.

Role of the Clinical Trial Management Office

The Clinical Trial Management Office performs “Clinical Research Coordinator (CRC) work” to support investigators or subinvestigators, and “Clinical trial office work” to carry out clerical procedures related to clinical trials.

About participating in clinical trials

1. For clinical trials that have been approved by the Institutional Review Board, physicians first call out to patients who meet the criteria (requests for participation may be made through posters, etc., or by letter).
2. After that, the doctor and clinical trial coordinator (CRC)* will give you a "trial explanation document" that describes the details of the trial, including the advantages and disadvantages, and explain the details.
3. Based on all of these, the patient will be asked to make a “judgement by themselves” as to whether or not they can participate in the clinical trial.
   If you agree to participate in a study, you may withdraw from the study at any time for any reason.

* Clinical trial coordinator (CRC)
At the direction of the investigator or subinvestigator, we will consult as many times as possible on behalf of the doctor who has limited time so that the patient does not have to worry about participating in the trial.

Clinical trial standard operating procedure (PDF)