Drug Information Q&A Q35. How can I participate in a clinical trial and what precautions should I take if I participate?
Answer
In general, participation in a clinical trial is recommended by a physician or a patient who sees a recruitment poster in a hospital and applies for it. Recently, an increasing number of patients apply for clinical trials after reading notices in newspapers or on the Internet.
Explanation
Each clinical trial has its own purpose and plan.
When a patient wishes to participate in a clinical trial, it is first necessary to confirm that his/her disease or condition matches the purpose and plan of the trial.
For example, if a clinical trial is being conducted for a drug to treat type 2 diabetes, we will ask the patient about the type of diabetes, the severity of symptoms, and whether or not he or she can come to the hospital to participate in the trial.
Then, at the medical institution where the clinical trial is being conducted, the patient will receive detailed explanations about the clinical trial from the physician in charge and the clinical trial coordinator (see Q34). At that time, patients can ask about any questions they do not understand.
It is not necessary to decide immediately whether to participate in a clinical trial. The patient can decide freely after discussing the advantages and disadvantages of participating with family members, friends, or, if the patient is already undergoing treatment, with the doctors at the medical institution.
If the patient decides to participate in a clinical trial, he or she again receives a full explanation at the medical institution in charge of the clinical trial and signs a consent form (informed consent) once he or she is satisfied with the decision. The decision to participate in a clinical trial is then made. Of course, the privacy of the trial participant will be protected, so the patient can participate with peace of mind.
After signing the consent form, or even after the trial has started, patients can withdraw from the trial of their own volition. They will not be treated unfairly.
However, it can be dangerous to stop taking a drug while a clinical trial is in progress. In such cases, please do not make such decisions on your own, but always consult your doctor.
Chart/Column
35|"Clinical Trials: Your Questions Answered
Source: "Clinical Trials: Your Questions Answered," published by JPMA.
