CLINICAL TRIALS - WHAT ARE THEY ALL ABOUT?
All drugs and treatments for cancer today were first tested in a clinical trial - thanks to millions of volunteers over the years. Any new cancer drug is first studied in the laboratory, usually on animals. If the drug looks promising in the laboratory, it is then carefully studied in humans. These studies are clinical trials, and they are done in phases.
A clinical trial is a research study that involves humans. These studies may be about finding new ways to screen for, reduce the risk of, diagnose, or treat disease. They are the main way researchers find out if a new treatment is safe and effective in people. Many times, a clinical trial is done to learn if a new treatment works better or has fewer side effects than treatments currently available.
Phase I trial: Sometimes called a “first in human” study. The purpose of a Phase I study is to learn about how safe the drug is in humans and to identify side effects. These trials are usually done with only a small group of people. This is the only kind of clinical trial that uses a placebo, that is, a pill that has no drug in it (sugar pill).
Phase II trial: If the drug is found to be safe and the side effects are tolerable, the drug advances to the next phase of study. Phase II trials are done in larger groups of people to learn how well the new drug works and look more closely at how safe the drug is.
Phase III trial: If the drug is found to work well and is considered safe, it moves to the third phase. In Phase III trials, the new drug is given to 1000-3000 people. This trial is done to confirm that the new drug works, evaluate side effects, and compare the new drug to drugs already being used.
After all of this work is done, which can take 10-15 years, the information learned by researchers is sent to the Federal Drug Administration (FDA). The FDA reviews the study data and if they are satisfied that the drug is effective and safe, they will approve the drug to be used in patients.
National Institute on Aging. What are clinical trials and studies? https://www.nia.nih.gov/health/ what-are-clinical-trials-and-studies