Corona Research Consultants, Inc.

CLINICAL RESEARCH

Clinical Research is the study of new drugs and/or medical devices
that show promise for treating disease and/or symptoms of disease.

Some clinical trials/studies examine the effectiveness of investigational drugs while others may compare investigational drugs to previously approved drugs. The clinical investigation of a previously untested drug is generally divided into three phases (Phase 1-3). Although in general the phases are conducted sequentially, they may overlap. There are additional phases (Phase 4) that are conducted after the medicine has been marketed.

	Phase 1 Clinical Studies – includes the initial introduction of an investigational new drug into humans. These trials are typically closely monitored and may be conducted in patients or normal volunteer patients. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness. The total number of subjects and patients included in Phase I studies varies with the drug, but is generally in the range of 20-80.
	Phase 2 Clinical Studies – includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects.
	Phase 3 Clinical Studies – are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship and to provide an adequate basis needed for the medication’s package insert and labeling of the medication. Phase 3 studies usually include from 1000 – 3000 patients.
	Phase 4 Clinical Studies – are investigations of a marketed drug or drugs to determine either continued effectiveness and/or competitiveness against other medications. Occasionally, this testing may also have a part in the development of the drug for an unrelated treatment regimen.