UCI faculty and staff participate in numerous clinical trial projects to study investigational drugs or devices. A clinical trial is defined as the controlled, clinical testing in human subjects of investigational new drugs, devices, treatments or diagnostics, or comparisons of approved drugs, devices, treatments or diagnostics, to assess their safety, efficacy, benefits, costs, adverse reactions, and/or outcomes.
Such studies may be conducted under an industry-developed protocol or an investigator-developed protocol. These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration, under Phase I, II, III, or IV, although they can be designed with the sole purpose of collecting and analyzing data about approved drugs or devices in order to contribute to medical knowledge about the treatment of a disease or medical condition.
These studies are usually funded by pharmaceutical companies and are an important part of the process to assure the safety and efficacy of the drug or device, obtain Food and Drug Administration (FDA) approval and bring a product to market.
Sponsored Projects (SP) is responsible for reviewing, negotiating and legally executing agreements from external funding sources. The resolution of many contractual issues requires coordination between the external funding source, Investigator and SP; the involvement of each party is essential to a successful contractual arrangement with mutually acceptable terms.