PROTOCOL-SPECIFIC RESEARCH SUPPORT

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PROJECT SUMMARY (See instructions): The UCCCC senior leadership is committed to funding protocols that have the highest potential for leading to larger scale clinical trials with the possibility of significant clinical impact and/or future external peer-reviewed funding. These studies are innovative, feasibility, or proof-of-principle studies that are deemed to be of highest priority to the Cancer Center. In the last budget period, priorities included the promotion of interdisciplinary, translational, and population research, as well as diversification of the types of trials funded by this mechanism. It is anticipated that Protocol-Specific Research (PSR) funds will support approximately 2 trials per year and will be used to fund the effort of nurses and data managers. The UCCCC issues an RFA, with specified deadlines, which is posted on the UCCCC website, distributed to Program Leaders and members of the Cancer Advisory Committee, and sent to all UCCCC members via email. The RFA outlines the application requirements, which include submission of the full study protocol, together with a one-page description of the importance and innovativeness of the study and rationale for funding, as well as a budget and budget justification. Per NCI guidelines, all studies must be investigator initiated, not otherwise funded, IRB-approved, and the budgets restricted to nursing and data management support. PSR proposals are reviewed by a committee comprised of the Director, Co-Deputy Director for Clinical Sciences, and the Associate Directors for Clinical, Basic, Translational, and Population Research. The review process takes into consideration scientific merit, innovativeness, and the likelihood that the project will lead to future large scale clinical trials or extramural funding. Funded projects are monitored on a regular basis, and accrual reports are required quarterly. If a protocol is accruing poorly, and/or it is no longer feasible to conduct the trial, the Director, in consultation with the Associate Directors, will suspend funding. Over the past 5 years, our procedures for soliciting and awarding PSR have been modified slightly. Rather than set specific submission deadlines, we have allowed for a more flexible (rolling) submission schedule to accommodate new studies opening throughout the year. In addition, protocols are first submitted to the Clinical Trials Review Committee (CTRC), and CTRC comments are provided to the reviewers. These same procedures will be employed in the next grant cycle to fund approximately two early-phase studies per year.