Clinical Trials are controlled patient studies that must be performed before a new drug or treatment is approvedClinical by the FDA. They are also done after a drug or treatment is approved to document the effectiveness of the treatment or to gain FDA approval to use the drug or therapy to treat..
Who pays for clinical research?
Funding for clinical research comes from both the federal government (through the National Institutes of Health) and private industry (pharmaceutical and biotech companies). The sponsor of the research hires physicians, who may work in a wide variety of health-care settings, to conduct the clinical trial. Read More
A Phase One Study
Phase I studies are primarily concerned with assessing the drug's safety. This initial phase of testing in humans is done in a small number of healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body--how it is absorbed, metabolized, and excreted. A phase I study will investigate side effects that occur as dosage levels are increased. This initial phase of testing typically takes several months. About 70 percent of experimental drugs pass this initial phase of testing. Read More
A Phase Two Study
Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients. Most phase II studies are randomized trials. One group of patients will receive the experimental drug, while a second "control" group will receive a standard treatment or placebo.. Read More
A Phase Three Study
In a phase III study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase III studies are randomized and blinded trials.. Read More
Post-Marketing-- Late Phase Three/Phase Four Studies
In late phase III/phase IV studies, pharmaceutical companies have several objectives:
(1) studies often compare a drug with other drugs already in the market; (2) studies are often designed to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) many studies are designed to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Read More
Should you Participate in Clinical Research
People participate in clinical research for a variety of reasons. People who volunteer for phase II and phase III trials can gain access to promising drugs long before these compounds are approved for the marketplace. They typically will get excellent care from the physicians during the course of the study. This care also may be free... Read More