How Can Patients Find Out About a Specific Investigational Drug

Investigational Drug Trials

Drugs undergo a specific process before they are approved by the FDA for use to treat disease in humans. For people waiting for a cure, this can seem like a long process, but it is important that drugs are thoroughly vetted before they go on the market.

When a new drug is first discovered, it is tested in a laboratory. The results of those tests determine whether it goes any further in the process to determine if it could be safe and effective to treat disease, or if it needs more research. A potential new drug that shows promise in the lab is moved to clinical trials.

The FDA regulates the process of new drug development by evaluating test results and determining if a drug is ready for the next stage of testing. Human testing can begin as soon as an application for investigational new drug (IND) is FDA-approved.

Clinical trials are designed to demonstrate the safety and effectiveness of a new drug for people. Lab studies may show positive results, but until the drug is tested on human subjects, its affects cannot be confirmed. The goal of clinical trials is to show the drug is safe for humans, to document any side effects, and ultimately to demonstrate how effective it can be at fighting disease.

Investigational Drug Applications

People are chosen to take part in investigational drug trials who meet certain criteria. Your doctor might mention a clinical drug trial as an option for you, depending on your diagnosis. You could also consult the National Cancer Institute’s database to learn about investigational drugs that are in the clinical trial stage. By calling 1-800-4-CANCER, you can obtain a list of clinical drug trials for which you might qualify.

Depending on your diagnosis, investigational drugs could be one of your best options for treatment. New cancer drugs are in development all the time, and those clinical trials cannot take place without patients. Drug companies need participation to complete final testing before they can bring potentially life-saving drugs to market.