PROTOCOL-SPECIFIC RESEARCH SUPPORT

项目概述（见说明）：UCCCC高层领导致力于资助最有可能导致更大规模临床试验的方案，这些试验可能产生重大临床影响和/或未来的外部同行评审资金。这些研究具有创新性、可行性或原则性，被认为是癌症中心最优先考虑的研究。在上一个预算期间，优先事项包括促进跨学科、转化和人口研究，以及使这一机制资助的试验种类多样化。预计协议特定研究（PSR）基金每年将支持大约2项试验，并将用于资助护士和数据管理人员的工作。UCCCC发布了一份RFA，并规定了截止日期，发布在UCCCC网站上，分发给项目负责人和癌症咨询委员会成员，并通过电子邮件发送给所有UCCCC成员。RFA概述了申请要求，其中包括提交完整的研究方案，以及一页关于研究的重要性和创新性、资助理由的描述，以及预算和预算理由。根据NCI指南，所有的研究必须是研究者发起的，没有其他资助，irb批准，预算仅限于护理和数据管理支持。PSR提案由主任、临床科学联合副主任和临床、基础、转化和人口研究副主任组成的委员会进行审查。评审过程要考虑到科学价值、创新性以及项目将来是否会导致大规模临床试验或校外资助的可能性。受资助的项目定期受到监测，每季度须提交应计项目报告。如果一项议定书进展不佳，和/或不再可行进行试验，主任将与副主任协商，暂停供资。在过去五年中，我们的征求和授予PSR的程序略有修改。我们没有设定具体的提交截止日期，而是允许更灵活的（滚动）提交时间表，以适应全年开设的新课程。此外，方案首先提交给临床试验审查委员会（CTRC），并将CTRC的意见提供给审稿人。下一个拨款周期将采用同样的程序，每年资助大约两项早期研究。

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.