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UCSD supports the participation of its researchers in the clinical trial testing of pharmaceutical company drugs and devices. Company funding for specific drug and device protocols can provide benefits to both the researcher and the company. It enables the researcher to receive additional funding for support of personnel and other costs and provides the company with an established human subject patient base in a large variety of areas for testing state of the art medical treatments.
The majority of clinical trials are conducted on a per patient cost basis. This means that the company will establish a fixed amount of money for each patient identified for the trial who either completes all or a portion of the protocol. Although an up-front payment may be negotiated in the contract, reimbursement usually only occurs after certain progress is accomplished. Consequently, acceptance of such contracts includes a risk component. Such risk of non-payment or partial payment must be assumed by both the researcher and his/her department.
UCSD assesses overhead of 19.5% on the total costs of the clinical trial. If the fixed cost per patient is the total cost that the sponsor is willing to pay, the overhead must be subtracted from the fixed cost before the balance of costs can be used for direct expenses.
In order for a study to be considered a clinical trial and qualify for the reduced overhead rate of 26%, the study must be conducted using a sponsor-initiated protocol. If a study is for a clinical trial using a researcher-initiated protocol, or the study is for testing of a University drug or device, the project is considered to be "research."
In order for any study involving human subjects to be conducted, a protocol must be approved by the UCSD Human Subjects Committee for the period of the study. For further information on how to submit such a protocol for approval, please refer to the information available on the School of Medicine web site.
Contracts for School of Medicine (SOM) sponsor-initiated protocol clinical trials are negotiated by the Clinical Trials Office in the Dean's Office/SOM.
Contracts for studies using a University drug or device or a researcher-initiated protocol are negotiated by the Office of Contract and Grant Administration (OCGA). Further information is available in the Research Agreements section of this web site.