Clinical research trials are studies designed to test a specific use for a given medication. Sometimes the medications are experimental and have not been approved by the Federal Drug Administration (FDA) for use or sale in the U.S. Other medications are currently approved for use but are being tested at a higher dose or to treat a new disease. Clinical research studies are conducted to help understand diseases and improve treatment, as well as to learn more about a drug, medical device or particular condition.
The research staff is required to follow a protocol approved by an Institutional Review Board (IRB). A review board is a committee of medical professionals and members of the community that assess the risks to patients and advocate patient safety. As the trial progresses, the research staff is required to provide ongoing review reports to the IRB to monitor patients' safety. Patients read and sign a consent form prior to any study procedures. The consent form explains in detail the benefits, risks and study procedures for the clinical trial.
Patients participating in the clinical research trials can benefit directly and their disease or symptoms may be helped. Other benefits include: