New tests and treatments aren’t offered to the public as soon as they’re made. They need to be studied. A clinical trial is a type of research that studies a test or treatment given to people. Clinical trials study how safe and helpful tests and treatments are. When found to be safe and helpful, they may become tomorrow’s standard of care. Clinical trials can study many things, such as:
New drugs not yet approved by the U.S. FDA (Food and Drug Administration), New uses of drugs already approved by the FDA, New ways to give drugs, such as in pill form, Use of alternative medicines, such as herbs and vitamins, New tests to find and track disease, and Drugs or procedures that relieve symptoms.
Clinical trials are carefully designed, reviewed, and completed. The principal investigator is the person in charge of the trial. He or she is a scientist who’s an expert in what the clinical trial is about. The principal investigator takes the lead in designing the clinical trial, choosing the research team, and carrying out the study. Often, other scientists, called investigators, are part of the research team.
Clinical trials need to be approved before they can start. Clinical trials need sponsors since they can’t be done without money or other support. Sponsors often are government agencies, pharmaceutical (drug) companies, and non-profit organizations. Sponsors of the clinical trial review the research plan (also called protocol). Funding or other support is given by the sponsor once the research plan is approved.