Enroll in a Sponsored Study
The Food and Drug Administration (FDA) regulates investigational studies. In addition, all studies are approved by an appropriate institutional review board (IRB). Specific information on any study, including the name of the IRB, is available to potential subjects. Potential subjects are urged to read the consent forms carefully. Personnel are available to answer any questions.
As a drug moves through the investigational process, the FDA classifies studies into four phases. These are:
--Phase I: This is the earliest use of a drug in human subjects, designed primarily to evaluate safety.
--Phase 2: These studies are intended to obtain more safety data, as well as to establish what appears to be optimal (the best) dosing.
--Phase 3: These are large scale studies designed to demonstrate that a drug is effective for a specific purpose. Additional safety data is also obtained. These studies often involve thousands of patients.
--Phase 4: Phase 4 studies are designed to learn more about drugs that have already been approved for treatment of patients by the FDA. These studies are generally designed to answer clinical questions as to the appropriate role of a particular medication in the treatment of asthma. For example, a new bronchodilator may be tested in patients with asthma, along with an alternative medication, in order to see what treatment works "best".