Have you ever been curious about how new medications are tested and approved by the FDA? Before your dermatologist can prescribe a treatment for psoriasis, warts, or any other condition, that drug must go through a rigorous review process, which includes clinical trials. Clinical trials are designed to test whether a particular drug is both safe and effective for use in humans.
Before researchers can test a drug in humans, they must determine its toxicity or whether it might cause serious harm. This is known as preclinical research. Preclinical research is conducted on animal test subjects. Then, the FDA carefully reviews all of the data the researchers have gathered from this testing to determine if it’s safe enough to move forward with human testing.
Phase I Studies
Most drugs are not approved for clinical trials in humans. Those that are move into phase I studies. Phase I studies are usually conducted on healthy humans. The primary purpose of these studies is to assess the potential side effects of the drug and determine how it is metabolized and excreted.
Phase II Studies
If the healthy volunteers from the phase I studies do not show significant toxicity, then the drug can be tested on humans who have the particular condition that the drug is intended to treat. Usually, phase II studies are controlled, which means that one group of volunteers receives the drug and the other group receives a placebo or standard treatment.
Phase III Studies
Phase III studies are much like phase II studies, except that they are performed on a larger scale. The goal is to continue to assess the drug’s effectiveness and safety. If a drug passes this clinical trial, then it may be submitted to the FDA for approval for marketing.
Phase IV Studies
Phase IV studies are also referred to as Post Marketing Surveillance Trials. Even after a drug has entered into the pharmaceutical marketplace, drug companies still want to know as much as they can about the product.
For years, the research center at Arlington Dermatology has helped many individuals enroll in phase two and three clinical trials to further dermatological advancements. This has allowed many of our patients to receive cutting-edge psoriasis treatment in Arlington Heights and treatments for other dermatologic conditions. If you are interested in talking to our dermatologist about enrolling in a clinical trial, you can call us at 847-392-5440.