What Is a Clinical Trial?
A clinical trial is research that carefully tests new ways to prevent, diagnose or treat diseases. It is a significant way to advance science and develop better therapies for patients with diseases similar to those being treated in a clinical trial and patients who choose to participate.
Clinical Trial Phases:
Phase I: The primary goal is to establish the overall safety. Phase I also includes establishing the maximum tolerated dosage, serious side effects and the pharmacologic action of the drugs.
Phase II: The primary goal is to establish the activity of a drug for specific group of patients with the specific disease. The secondary goal is to determine the typical short-term effects and risks.
Phase III: The primary goal is to confirm the safety and effectiveness of a drug for specific group of patients with the specific disease. The secondary goal is to evaluate the overall risk-benefit ration.
Phase IV: The primary goal is to monitor safety in large populations, and the secondary goal is to usually identify side effects and identify additional potential uses of the drug.