Coronavirus: What is a clinical trial?

So what is a clinical trial?

Clinical trials are research studies aimed at evaluating a medical, surgical or behavioral treatment, according to the National Institutes of Health.

A clinical trial is used to find out if the experimental treatment will be effective. The study also helps researchers determine if there are harmful side effects.

There are four phases of clinical trials. But before those start, the Food and Drug Administration makes the determination if a treatment should be tested in humans.

Scientists perform laboratory tests and studies in animals, if these tests show favorable results the FDA will approve clinical trials.

The four phases of a clinical trial test a treatment, find the appropriate dosing and determine potential side effects. The fourth phase is when the FDA then approves the drug for clinical, widespread use and continues to monitor its effects.

Phase I

A group of about 20-80 people are used to judge the safety of an experimental treatment.

Phase II

A larger group of people, up to 300, test the efficacy of the treatment. Researchers continue to study safety and short term side effects. This phase can last several years.

Phase III

Researchers gather more information about the treatment’s safety and effectiveness, as well as study dosages. The test group at this stage is increased to about 3,000 people. If the trial results show promise, the FDA approves the experimental treatment.

Phase IV

After approval, the FDA continues to monitor the safety and effectiveness. Side effects unseen in earlier phases could be found during this stage.

For more information about clinical trials or to be a participant in one, visit: ClinicalTrials.gov.