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 medicine or treatment regimen is safe and effective
against a specific condition or disease.
Clinical trials compare
the effectiveness of the study medicine or treatment against standard,
accepted treatment or a placebo. (A placebo is 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. These rules make sure that participants are not likely
to be harmed and that they fully understand the risks and benefits of
participating.