What happens to the information gathered in a clinical trial?
The information gathered during the course of a clinical trial is carefully evaluated to determine whether the investigational drug or device is safe and effective enough to move into the next phase of study. In some cases the results are extremely encouraging but in some cases the investigational drug or device is determined to be unsafe or ineffective. If a treatment is proven to be safe and effective after the completion of the phase III trial, the clinical trial results are presented to the FDA for review. If approved by the FDA, the new treatment then becomes available to the general public offering a new treatment option for physicians and their patients. In this way, clinical trials help to bring new therapies to patients with a wide range of medical conditions.