Clinical Trials

Study participants and researchers both know which treatment the patient is receiving. Open-label trials can be used to compare treatments or gather additional information about the long-term effects in the intended patient population.

Clinical trials use a double-blind approach: study participants and researchers don’t know which treatment the patient is receiving.

Comparative effectiveness clinical trials are randomized comparisons of treatments designed to determine which treatment options are superior.

Learning if a new drug, treatment, or treatment combination is safe for people.

Phase II of a clinical trial involves several hundred participants who are living with the condition that the new medication is meant to treat.

Postmarketing study commitments are studies required of or agreed to by a sponsor that are conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use.