Clinical trial

A clinical trial is a research study on human volunteers designed to answer specific health questions. The purpose of a clinical trial is to find out whether a medication or treatment regimen is safe and effective against a specific condition or disease.

Clinical trials compare the effectiveness of the study medication or treatment against standard, accepted treatment or a placebo (an inactive substance used to compare results with an active substance). Early (phase I) trials establish the safety, toxicity, and safe dosing ranges of a new treatment.

A clinical trial may be sponsored by a government agency, such as the National Institutes of Health, or a pharmaceutical or biotechnology company. All clinical trials are guided by government regulations to ensure that participants are not likely to be harmed and that they fully understand the risks and benefits of participating.

Last Updated: June 4, 2008

Author: Bets Davis, MFA

Medical Review: Anne C. Poinier, MD - Internal Medicine & Michael Seth Rabin, MD - Medical Oncology

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