From the laboratory to your medicine cabinet — the process of researching and developing a drug is long, complicated and costly. It takes an average of 10 years and more than $2 billion to bring a new medication or therapy to market. Less than 15% of all the drugs in development make it through to patients.
Drug Approval Phases
Before a drug is approved, it must go through rigorous testing to determine if it is safe and effective.
- Pre-Clinical: Researchers look at how the drug may work in the body (mechanism of action), dosage, side effects, and effectiveness of the drug. The drug is tested in animals to get an idea of how it may work in humans.
- Phase I: If the findings from this pre-clinical research offer promising data on the compound, scientists then move into phase I of clinical trials. In order to begin clinical trials, researchers must apply to the Food and Drug Administration (FDA) to show that the study meets the minimum FDA research requirements. The drug is then tested in a small group of people usually without eczema to better understand the mechanism of action, general safety, and if there are side effects.
- Phase II: The drug is tested on a larger group of people who have eczema to see how the drug works and if it is safe.
- Phase III: The drug is tested in even more people with eczema to further assess effectiveness, safety, and side effects.
- FDA Approved: FDA deems the drug is effective and safe for treating eczema.