Drug Information Q&A Q34. What is a clinical trial, which is an important step in the development of a drug?
Answer
A clinical trial is the final step in the development of a drug, and is conducted with the cooperation of patients. The efficacy and safety of a drug are finally confirmed through clinical trials.
Explanation
A drug is created after a long research and development period of 9 to 17 years. During this time, various tests are conducted to confirm the properties of the ingredients, how they work, and whether or not and to what degree they are toxic.
In the final stage, the safety of the drug is first tested in healthy subjects, and then the efficacy and safety of the drug is confirmed in patients actually suffering from the disease. This is called a clinical trial.
For example, in order to develop a drug for diabetes, we need the cooperation of volunteer diabetes patients to test whether the drug is effective, whether it is safe to use, and whether it is in an easy-to-use form.
Drugs are only approved after their efficacy and safety have been confirmed through clinical trials. All the drugs we use today are the result of volunteer efforts by many patients.
Clinical trials are conducted at hospitals and other medical institutions by physicians, nurses, pharmacists, and clinical trial coordinators who support clinical trials.
Patient safety is the top priority when conducting a clinical trial. A system is in place for safety management and consultation by physicians and others, and if side effects or other symptoms are observed, appropriate measures are taken immediately.
Pharmaceutical companies are in charge of planning, collecting information and managing clinical trials based on the "Good Clinical Practice (GCP) for Drugs," which was established by law to ensure safety and protect human rights.
In this way, clinical trials are conducted in cooperation with patients, medical institutions, and pharmaceutical companies.
Clinical trials are divided into three phases.
In Phase I trials, a small number of healthy subjects are enrolled to confirm the safety of the drug, including side effects.
In the next phase, Phase II, we will confirm effective and safe dosing and usage in a small number of patients.
In the final phase III trial, the efficacy and safety of the drug will be compared with those of existing standard drugs in a large number of patients.
- *Clinical Trial Coordinator
A professional staff member who acts as a liaison between patients, physicians, and pharmaceutical companies to support the smooth operation of clinical trials. In many cases, clinical trial coordinators are nurses, pharmacists, and others with knowledge of nursing and pharmaceuticals.
Chart/Column
34｜How to proceed with a clinical trial
Source: JPMA, "Clinical Trials: Your Questions Answered.
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