Clinical Trials
Industry-Initiated Clinical Trials
For Frequently Asked Questions, click here.
For an Investigator-Initiated vs. Industry-Initiated Clinical Trials Quick Reference Guide, click here.
A. Protocol for Industry-Initiated Clinical Trials:
The protocol is authored by:
A non-UC employee (i.e the company's employee or an employee of an outside university or institution), or
A University investigator under a personal consulting agreement and without use of University facilities in accordance with UC policies.
To view the University of California Executive Summary on personal consulting entitled, "Guidance for Faculty and Other Academic Employees on Issues Related to Intellectual Property and Consulting, click here.
B. Indirect Cost for Industry-Initiated Clinical Trials:
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Industry-Initiated Clinical Trials are subject to the 26% (Total Direct Cost) Clinical Trial Indirect Cost Rate. Contact the Clinical Trial Administrative Services and Research Compliance Office (CTAS) at 858-822-4653 for additional information or by e-mail at rcp@ucsd.edu.
C. Funding Source for Industry-Initiated Clinical Trials:
A for-profit entity must be the source of funding for an Industry-Initiated Clinical Trial.
D. Payment Schedule for Industry-Initiated Clinical Trials:
Although the actual payment schedule is subject to negotiation with the sponsor, the Principal Investigator and departmental administrators should develop a suggested payment schedule that is based upon the spending pattern anticipated for the study.
The University should not underwrite expenses for the sponsor.
The initial payment should also include non-refundable start-up costs, as appropriate.
Subsequent payments may be due quarterly, or based on subject enrollment.
Since payment options may vary, contact CTAS to discuss appropriate terms for a specific clinical trial.
E. FDA Phase for Industry-Initiated Clinical Trials:
In general, Industry-Initiated Clinical Trials may include Phase I through IV and may also be multi-site studies.
F. Investigational New Drug (IND) for Industry-Initiated Clinical Trials:
The FDA form 1571 is completed by the industry sponsor who takes responsibility for and initiates the clinical investigation.
G. Publication and Mandatory Registration Requirements for Industry-Initiated Clinical Trial Results:
The University retains the right to publish the results of the Clinical Trial consistent with University policy.
Public Law 110-85, the FDA Amendments Act, mandates registration of Phase 2 - 4 clinical trials of drugs and biologics, and devices. The sponsor (as defined in 21CFR 50.3) is responsible for registering such Industry-Initiated clinical trials. However, the Principal Investigator must coordinate with the industry representative to determine who will assume the responsibility to register the trial. Although registration of Phase 1 clinical trials is not required under the Act, the ICMJE may require that the trial is registered in order for the results to be considered for publication in an ICMJE journal.
For further detailed information, click here.
H. Intellectual Property Rights for Industry-Initiated Clinical Trials:
In general, the industry sponsor will own any patentable inventions developed in the direct performance of the protocol, since the protocol is conceived and authored by the industry sponsor.
In such case, it is unlikely that a University investigator will be identified as an inventor.
The University retains ownership rights in any inventions that may be developed outside the protocol.
I. Data for Industry-Initiated Clinical Trials:
The industry sponsor owns the completed case report forms and compilation of data expressed therein that is developed under the trial, and any deliverables required under the protocol. However, the University retains the right to use the case report forms and results for publication, educational and research purposes.
The industry sponsor may receive and use de-identified clinical trial specimens (blood samples, x-rays, etc.).
The University retains ownership and unrestricted use of original "raw" data including clinical trial specimens. The industry sponsor may have access to raw data for FDA inspection/monitoring.
The industry sponsor may access, but not copy, subjects' medical records containing individual identifiable patient information for the limited purpose of auditing data quality and monitoring the study as required under FDA regulations. The disclosure is allowed under HIPAA, however, such disclosure is not allowed under CMIA without subjects' authorization. The UC HIPAA Authorization is used to ensure compliance with both state and federal laws.
J. Subject Injury for Industry-Initiated Clinical Trials:
The industry sponsor is responsible for any injury directly resulting from a subject's participation in the trial, or injuries resulting from the study drug, or the placebo, or protocol procedure(s).
The industry sponsor will reimburse the University for the reasonable costs of medical treatment for such injuries.
It is unacceptable to require billing of third party insurance companies in lieu of recovery of such costs from the industry sponsor.
Neither is it appropriate to restrict participation of subjects based on medical insurance coverage status or the subject's ability to pay their own.
K. Required Forms for Industry-Initiated Clinical Trials:
- The completed forms below are to be submitted
to the Clinical Trial Administrative Services and Research Compliance
Office (CTAS) Office; Mail Code 0706.
- Clinical Trial Agreement Request
- 700U Conflict of Interest completed by PI and Co-P
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Budget including 26% IDC
L. Authorized Administrative Office for Industry-Initiated Clinical Trials:
Industry-Initiated Clinical Trials are processed and negotiated by the Clinical Trial Administrative Services and Research Compliance Office (CTAS); Mail Code 0706. Please contact Gail Zydlewski at gzydlewski@ucsd.edu, or at 858-534-1021 with any questions.
