Clinical Trial Definition

A clinical trial is a scientific research study that is typically designed to test the safety and effectiveness of a new drug, device or treatment on humans. A clinical trial is conducted with voluntary patients who qualify according to set inclusion/exclusion criteria which are usually based on age, gender, type or stage of disease, treatment history and other medical conditions.

Participants in clinical trials can potentially gain access to new treatments before they are available to the public and obtain expert medical care. However, many trials are "randomized," which means that participants are randomly assigned to receive either the new treatment or the control group (e.g. current standard of care or placebo) treatment, so not all participants will receive the drug or device being studied.

Also, participants run the risk of serious or life-threatening side effects to any new treatment. In the United Statues, clinical trials are conducted under the direction of the Food and Drug Administration (FDA) before being made available for general clinical use in healthcare.