III. Assistance Concerning Clinical Trials
An investigational drug is one that is under study but permission from the FDA to legally market and sell the drug in the US has not yet been granted. FDA approval is the final step in the process of getting a drug on the market. The first step is an application by a drug company or sponsor for FDA approval to test a drug in people. If an Investigational New Drug (IND) Application is approved by the FDA, clinical trials can begin.
Clinical trials are research studies to determine the safety and measure the effectiveness of a drug in people. Your doctor may suggest a clinical trial as one treatment option or you may ask the doctor if there is a clinical trial that you should consider.
Patients and their families can learn about ongoing clinical trials by using the National Cancer Institute’s PDQ database. If you want to consider participating in a clinical trial, medical advocate assistance is available here to help you discuss possible clinical trials with your treating physician.