What is the role of a clinical trial in drug development?

The primary role of a clinical trial in drug development is to test the safety and efficacy of a drug to support its approval by regulatory agencies like the FDA. Clinical trials are structured studies that involve human participants and aim to gather data on how well the drug works, what side effects it may cause, and how it compares to existing treatments.

This process is essential because it provides the evidence needed to determine whether a drug can be safely used in the general population. The trials typically occur in phases, starting with a small group of healthy volunteers and progressing to larger groups of patients. Each phase is designed to gather specific information that contributes to a comprehensive understanding of the drug's performance under controlled conditions.

When a drug is shown to be both safe and effective through these trials, it can be submitted for FDA approval, which is a critical step in bringing new medications to market. This rigorous evaluation helps to protect public health by ensuring that only thoroughly tested and proven medications are made available.