What are the three phases of clinical trials? | Dr. Todd Lanman

There are three phases in clinical trials. And let's be clear; this is the way the FDA stipulates how they are to be conducted for approval. I've done many clinical trials for artificial disc replacement, and this is the process we follow. For the first phase, we will study the safety of the device with 20 or so patients who are otherwise healthy. In the second phase, we will draw on a larger body of patients (100 or more) and study the efficacy of the drug or device that's being considered. In the third phase, we add randomized and blind testing to ensure that the drug or device is at least equivalent or better than other solutions we have on hand. Of course, through all the testing, we're focused on safety to the patient and effectiveness in its designed use.