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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 0: Clinical trial is done with a very small number of people, usually fewer than 15.  Investigators use a very small dose of medication to make sure it isn't harmful to humans before they start using it in higher doses for later phases. 


Phase I: The phase aims to figure out the highest dose humans can take without serious side effects.  Investigators monitor participants very closely to see how their bodies react to the medication during this phase. While preclinical research usually provides some general information about dosing, the effects of a medication on the human body can be unpredictable.


Phase II: The primary goal is to establish the activity of a drug for a specific group of patients with the specific disease.  The secondary goal is to determine the typical short-term effects and risks.  Investigators monitor patients for several months or years to see how effective the medication is and to gather more information about any side effects it might cause.


Phase III: The primary goal is to confirm the safety and effectiveness of a drug for a specific group of patients with a particular disease.  The secondary goal is to evaluate the overall risk-benefit ration.  The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options


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.  Phase IV clinical trials happen after the FDA has approved medication. This phase involves thousands of participants and can last for many years. Investigators use this phase to get more information about the medication’s long-term safety, effectiveness, and any other benefits.

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