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。这些临床试验具有创新性、可行性（即，1期前，试验）和I期临床干预，重点是测试用于诊断、预防、检测或治疗癌症的试剂或装置。通过合作小组机制或通过独立赠款支持，积极的试验导致了更大规模的外部资助研究。UCCC有一个正式的机制，用于优先考虑PSR支持的试验。该过程由PSR医学总监和PRMC主席监督。在中心范围的RFA通知后，每月对无资金支持的研究者发起的研究进行同行评审。Kane博士指定评审员对符合PSR资助条件的研究进行评审。这一进程与PRMC的审查同时进行，以避免工作重复。资格和优先顺序根据定义的标准确定鼓励一些Pis根据匿名书面评论修改并重新提交研究。根据临床研究协调员（CRC）和数据管理职责所需的时间和工作量计算分配资金，仅可用于CRC和数据管理支持。 如果需要，研究者需要通过其他机制寻求患者护理和/或其他费用的支持。在本资助期内，37项PSR批准的试验正在进行中。迄今为止，这些审判的应计案件总数为734起。这比过去两个供资CCSG期间的281（2000年）和401（2005年）有显著增加。根据我们提出的2.67个FTE用于CRC支持的预算，我们的平均每年应计122个平均值为每个CRC每年应计-46个，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，还需要频繁的患者访视、药代动力学和标本采集。 到目前为止，这些成果已经产生了22篇出版的手稿，3篇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，这些项目由外部赞助商资助，包括Susan G。科门基金会和SWOG;还有两个正在开发（RTOG）和已提交（R21）。尽管应计增长，我们希望进一步扩大该计划的成功和在该领域的影响， 在下一个资助期，通过筹款创建一个捐赠基金，为研究者提供资金和服务，用于在成功完成PSR试验后准备后续更大规模的研究。这将包括方案制定、财政和生物统计支持以及设计服务。

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.