What Are the Phases of Clinical Trials?

 

You may have questions about how clinical trials work, especially when you are somebody suffering from a debilitating disease or condition and could benefit from a drug that will help you in a variety of ways as you’re trying to get back on your feet. Before you consider the clinical trial, there are many things that you should know.

What happens before a clinical study can even take place? First of all, someone must be able to consent to the trial, because they cannot be forced into it. Informed consent is seen as a very important step in the process, with it having its own section in the 9th revision of the American Psychological Association’s Ethical Code. If a researcher wants to use children in a clinical trial, they are legally required to obtain consent from the parent of the child.

How the Various Stages Work

There are many phases of a clinical trial, from the phase 1 clinical trial to the phase 4. In the phase 1 clinical trial, a researcher will test an experimental drug on a small group of people for the first time. The reason behind this phase is to evaluate the trial and identify any side effects. In phase 2, the experimental drug will be given to a larger group of people to determine the effectiveness. This could range anywhere in the hundreds. In phase 3 of the trial, the drug will be given to an even larger group of people, sometimes in the thousands, to confirm how effective the drug seems to be and monitor its effects. It will be compared to other drugs much like it on the market. In phase 4, lastly, it will either be approved or denied as it pertains to going on the market. Many drugs won’t actually make it to FDA approval, and it will end there.

Clinical drug development takes on many forms and can be extremely time-consuming. Medical research studies are extremely integral to the development of new life-saving drugs that can play a huge role in the lives of many. Have all of your questions been answered pertaining to a trial? Do you believe you could play an important role in the development of a new drug? You have an option that could change the world.