The goal of the Protocol Specific Research (PSR) Program is to provide data management and other infrastructure support for novel clinical trials designed and implemented by UCCC memebrs. These clinical trials are innovative, feasibility (i.e., pre phase 1, pilot) and phase I clinical interventions focused on testing an agent or device for the diagnosis, prevention, detection or treatment of cancer. Positive trials have led to larger externally funded studies, either through cooperative group mechanisms or through independent grant support. The UCCC has a formal mechanism for prioritizing trials for funding with PSR support. This process is overseen by the PSR Medical Director and the Chair of the PRMC. Peer-review for unfunded investigator initiated studies is carried out monthly after a center-wide RFA notification. Reviewers are assigned by Dr. Kane to review a study eligible for PSR funding. This process occurs in conjunction with the PRMC's review in order to avoid duplication of efforts. Eligibility and prioritization is determined based on defined criteria Some Pis are encouraged to revise and resubmit the study based on the anonymous written reviews. Funds are distributed based on calculation of the time and effort needed for Clinical Research Coordinator (CRC) and data management responsibilities and can be used for CRC and data management support only. Investigators are required to seek support through other mechanisms for patient care and/or other expenses, if needed. 37 PSR approved trials have been active during the current funding period. To date, total accrual for these trials has been 734. This is a remarkable increase from the past two funding CCSG periods at 281 (2000) and 401 (2005). Based on our proposed budget for 2.67 FTEs for CRC support, our average annual accrual of 122 averages to -46 accruals per CRC per year, a significant workload since these early phase trials often require frequent patient visits, pharmacokinetics and specimen collection in addition to data entry. The outcomes thus far have resulted in 22 published manuscripts, 3 abstracts and presentations of data at national or international meetings, 4 on-going research projects with funding from external sponsors including the Susan G. Komen Foundation and SWOG;and two others under development (RTOG) and submitted (R21). Despite accrual growth, we wish to further expand the program's success and impact in the field in the next funding period by fundraising to create an endowment that would provide funds and services for investigators to use in preparation of subsequent larger studies after successful completion of PSR trials. This will include protocol development, fiscal and biostatistical support and design services.

Public Health Relevance

The Protocol Specific Research component of a Cancer Center Support Grant provides specific support for short-term, feasibility (i.e. pre-phase 1 and pilot) and phase I clinical trials that originate with the investigators at the University of Colorado Cancer Center. This support allow investigators to test novel ideas and generate preliminary data that can be used as the basis for later phase trials funded through competitive grant applications, cooperative groups or industry.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Subcommittee G - Education (NCI)
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University of Colorado Denver
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