What is a Phase I Clinical Drug Trial?
Clinical trials are research studies conducted in human volunteers to answer specific health questions about a new treatment or a new way of using an old treatment. They are the best and safest way for finding new and more effective therapies and for progressing the field of medicine. There are three phases of clinical trials intended for support of a new drug or biological. In the first phase, the safety and efficacy of the drug or biological is tested in a small number of patients, and patients are closely monitored for side effects. The safety of the treatment is tested at various dosage levels. In Phase II, the study is opened up to more patients, usually no more than 50, in order to further test the safety and efficacy of the study drug or biological. The Phase II study is used to identify the optimum dose for the treatment and any related adverse events, and the production process for the product is refined. Only if the treatment has shown success in the first two phases will the
