5. Precautions against side effects in clinical trials
Special attention is paid to side effects in clinical trials
While drugs have various effects on the symptoms of diseases, they also have undesirable effects (side effects). In clinical trials, the greatest attention is paid to safety, which is one of the concerns of patients participating in clinical trials.
If you experience any unfamiliar rash, fever, sore throat, difficulty in stopping bleeding, or any other worrisome symptoms while using a "drug candidate," promptly notify the physician conducting the clinical trial.
In addition, please read carefully the explanatory document given to you at the time of informed consent, which explains the side effects seen so far with the investigational drug and the expected side effects, and includes precautions.
Precautions paid during the clinical trial
- Many times during the course of a clinical trial, a representative from the pharmaceutical company will visit the hospital to confirm that medical examinations and tests are being performed as scheduled.
- The Clinical Trial Review Committee, which reviewed the details of this clinical trial prior to the start of the trial, also examines whether the trial is being conducted properly at least once a year.
- In the event of a death or any other unknown serious side effects during the course of the clinical trial, the Clinical Trial Review Committee and the pharmaceutical company will be notified immediately. Upon receiving the notification, the Clinical Trial Review Committee will review whether or not the clinical trial can continue. In the case of a new serious adverse reaction, the contacted pharmaceutical company will report it to the government within a set time limit and, if necessary, review the clinical trial.
- During the course of participation in the clinical trial, the side effects observed in other patients will be explained and the patient's willingness to continue participating in the trial will be confirmed.