Clinical trials are a type of clinical research designed to look at new ways to prevent, detect, or treat disease. Clinical trials rely on the participation of volunteers (participants) and follow a research plan or protocol created by the investigators running the study. Participants in a clinical trial may include people with a specific disease or condition and/or healthy volunteers. The goal of a clinical trial is to determine whether a specific diagnostic, treatment, prevention, or behavior approach is safe and effective.
There are strict rules and regulations for clinical trials, which are monitored by the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Similar agencies monitor clinical trials in most other countries around the world. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.
ClinicalTrials.gov Learn about Clinical Trials
NIH Clinical Research and You: The Basics
NCATS Toolkit for Patient-Focused Therapy Development: Clinical Trials
U.S. Food and Drug Administration (FDA): Clinical Research Versus Medical Treatment