What does it mean: Phase One, Phase Two, Phase Three clinical trials?
When a drug or other product has undergone successful preclinical testing, a pharmaceutical company provides this data to the Food and Drug Administration (FDA), requesting approval to initiate testing of the treatment in humans. This is called an Investigational New Drug application (IND). Receiving FDA-approval, the company will initiate a Phase One clinical study. A Phase One Study is the earliest use of an FDA-approved pharmaceutical in people. Phase I studies require specialized monitoring and lab facilities as well as a skilled investigative group to ensure safety of the product and to perform the sophisticated data analyses needed. A Phase I study usually involves a small number of healthy patients, perhaps 20 or more, and also investigates side effects that may occur as dosage levels are increased. A Phase Two Study enrolls a carefully screened group of patients into detailed protocols to study a product’s clinical efficacy. This testing phase may last up to two years, and invo
