Clinical Trial Agreements

Overview

UC Davis supports the participation of its researchers in the clinical 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.

Total Costs

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.

UC Davis assesses an established indirect rate on the total costs of the clinical trial. A study may be conducted using either a sponsor-initiated protocol or a researcher-initiated protocol. The same indirect rate applies to both types of protocols.

Institutional Review Boards

In order for any study involving human subjects to be conducted, a protocol must be approved by the UC Davis Institutional Review Boards (IRBs) for the period of the study. For further information on how to submit such a protocol for approval, please refer to the IRB website

UC Davis Clinical and Translation Science Center (CTSC)

The CTSC enhances UC Davis’ rich and pioneering research environment by providing specialized infrastructure, expertise, leadership and assistance in the development and performance of high-quality, patient-focused research programs.

The CTSC provides faculty, staff and trainees with infrastructure and operations support to facilitate grant writing, research design, fiscal and protocol compliance, and data management in the conduct of clinical and translational research.

Key Issues for a Clinical Trial Agreement (CTA)

Typical terms in a clinical trial agreement may include the following:

Financial Arrangements

Generally, the university negotiates a firm fixed-price per subject contract with a payment schedule. Such schedules usually provide for periodic payments at regular intervals or payments upon the completion of milestones (e.g., enrollment of a certain percentage of subjects, submission of a certain number of case report forms, etc.). The University cannot underwrite expenses for the sponsor; therefore, the university requires a minimum advance payment of 10-20% of the total anticipated cost upon execution of the agreement. When a project involves significant start-up costs, the university may require a larger initial payment. As a public-supported institution, the university must recover the full cost of research conducted for outside sponsors, including all associated operating costs. To do otherwise would result in subsidizing for-profit research with public funds.

Termination

Generally, either party must have the ability to terminate the agreement by giving reasonable notice. In the event of premature termination, the university will seek reimbursement from the sponsor for all actual costs, as well as, uncancellable obligations incurred up to the termination date. In addition, untimely withdrawal from the protocol could jeopardize the safety and welfare of human subjects enrolled in the project. Therefore, the university requests that the sponsor cooperate with the university to safely withdraw subjects from the protocol as a part of terminating the project.

Confidentiality of Sponsor

UC Davis must maintain an open academic environment to fulfill its mission and meet its fiduciary responsibilities as a public educational institution. Clinical studies involving the use of a sponsor’s confidential information will be accepted if: (1) the extent of confidential information shared with the university is limited; (2) the information is clearly identified by the sponsor as confidential: and (3) the sponsor agrees that the university will not be financially liable for disclosure. The university cannot accept projects requiring overly-broad access and use restrictions or elaborate data protection procedures. Raw source data or documentation generated by the university during the conduct of a clinical study cannot be considered to be owned by the sponsor, nor can it be considered or treated as confidential information. In addition, any agreements entered into by the university are subject to public disclosure under the State of California Public Records Act, as well as the Federal Freedom of Information Act.

Publication of Study Results

Timely publication and dissemination of research/study results is an important principle behind the academic freedom afforded to each university faculty member. However, the sponsor is afforded the opportunity to comment on the content of such publications, make arrangements for the protection of intellectual property, or ensure that sponsor confidential information is not improperly disseminated in such publications. These are legitimate business concerns and the university works with sponsors to address these concerns. However, the resulting agreement cannot restrict university faculty from freely publishing research/study results. UC Davis negotiates CTAs that address the needs of both parties by providing the sponsor with a pre-publication review and comment period. The sponsor may also request that their confidential information be removed from the proposed publication. UC Davis is also willing to delay dissemination of study results for a reasonable period of time to accommodate multi-site studies, as well as for protecting items of intellectual property.

Patents and Inventions

Sponsors of university research are granted patent rights in accordance with university policies. However, the university may grant greater rights to sponsors of clinical trials that meet all of the following criteria:

The clinical investigation is an FDA Phase I, II, III or IV drug study or an FDA regulated medical device study.

The sponsor provides its proprietary product and study protocol to the university for the investigation.

The clinical investigation conducted according to the sponsor’s protocol is fully funded by the sponsor and is not supported in whole or in part with any other funds, including federal funds, gift funds or foundation funds.

There are no known third-party rights to intellectual property of the university that would be compromised by granting rights to the clinical trial sponsor.

All university requirements regarding the administration of agreements with private sponsors for drug and device testing using human subjects have been satisfied.

If all of the above criteria are met, the university may grant to the sponsor a certain range of rights to inventions made by university researchers in the direct performance of the clinical trial protocol. The terms contained in the standard clinical trial agreement are used for Phase III or IV trials meeting the above criteria and involving little or no investigator involvement in the conception or development of the protocol. However, the university reviews patent terms on a case-by-case basis and prefers to do so with a thorough understanding of the work contemplated.

Use of Name

California Education Code Section 92000 provides that the name “University of California” is the property of the state of California, and either the name, or any abbreviation of it may not be used by anyone without the permission of the Regents of the University of California. Consequently, the use of the university’s name to suggest that it endorses a product or service is not allowed. However, a sponsor may use the university’s name to fulfill their obligations as required by law, or by otherwise requesting prior written approval from the university.

Indemnification/Insurance

When conducting a sponsor-designed clinical trial protocol, the university is following the sponsor’s detailed instructions, as presented in the protocol for each clinical trial. As a public, non-profit educational institution, the university cannot bear the financial responsibility for any injury or damages resulting from the performance of the clinical trial. Consequently, the university requires that the sponsor maintain a policy or program of insurance sufficient to support this obligation. All clinical trial agreements with the university contain a provision detailing sponsor’s obligation to indemnify the university against all claims based on following sponsor’s directions in performance of the clinical trial. The sponsor’s obligation to assume all financial responsibility does not apply to injury or damage that are caused by: 1) caused by UC Davis’ failure to adhere to the protocol; 2) failure to comply with FDA or other governmental requirements; or 3) caused by the negligence of a faculty member or the university.

Subject Inquiry

As a matter of university policy, in the case of subject injury resulting directly from study drug administration or any study procedures carried out in accordance with the sponsor-designed protocol, the university will provide reasonably necessary medical treatment. University policy specifically prohibits billing the subject or a third-party for the costs of treating such injuries. Therefore, the university requires reimbursement for the cost of such treatment from the sponsor, and all clinical trial agreements contain a corresponding provision. Human subject welfare is a primary concern for the university and exceptions to these terms cannot be accommodated.

Applicable Law

The University of California is a constitutional corporation of the State of California and contract accepted by the university must be interpreted under California Law, excluding the conflicts of the laws provisions. The university will also consider contractual silence regarding this issue, but cannot negotiate any other terms.