PROTOCOL SPECIFIC RESEARCH

方案特定研究(PSR)计划的目标是为UCCC成员设计和实施的新型临床试验提供数据管理和其他基础设施支持。这些临床试验是创新的、可行的(即前期1期试点)和I期临床干预措施，重点是测试用于诊断、预防、检测或治疗癌症的试剂或设备。无论是通过合作小组机制还是通过独立的赠款支持，积极的试验都导致了更大规模的外部资助研究。UCCC有一个正式的机制，用于在PSR支持下确定资助试验的优先顺序。这一过程由PSR医务主任和PRMC主席监督。在中心范围的RFA通知之后，每月对无资金支持的研究者发起的研究进行同行审查。评审人员由凯恩博士指派，负责评审一项有资格获得PSR资助的研究。这一进程与减贫战略委员会的审查同时进行，以避免重复工作。资格和优先顺序是根据确定的标准确定的，鼓励一些私人投资机构根据匿名书面审查修改和重新提交研究报告。资金是根据临床研究协调员(CRC)和数据管理职责所需的时间和精力计算分配的，只能用于CRC和数据管理支持。 如果需要，调查人员需要通过其他机制寻求患者护理和/或其他费用的支持。在本供资期间，37项经PSR批准的试验仍在进行中。到目前为止，这些试验的应计总额为734项。这与前两个资助CCSG期间的281(2000年)和401(2005年)相比有了显着的增加。根据我们提议的2.67 FTE用于CRC支持的预算，我们平均每年122次的应计到每个CRC每年-46次的应计，这是一个巨大的工作量，因为这些早期试验除了数据输入外，通常还需要频繁的患者探视、药代动力学和样本采集。 到目前为止，成果已经产生了22份已发表的手稿、3份摘要和在国家或国际会议上的数据介绍、4个正在进行的研究项目，由包括苏珊·G·科曼基金会和SWOG在内的外部赞助者提供资金；另外两个正在开发中(RTOG)并已提交(R21)。尽管实现了应计增长，但我们希望进一步扩大该计划在外地的成功和影响 在下一个资助期，通过筹款建立一个捐赠基金，提供资金和服务，供研究人员在成功完成PSR试验后准备随后的更大规模的研究。这将包括方案制定、财政和生物统计支助以及设计服务。

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.