Protocol Specific Research

在没有其他来源的情况下，City of Hope（COH）申办的试验的绝大多数患者招募 同行评审支持的主要对象是COM临床研究者进行的I/II期和试点试验。这是 可能由CCSG的方案特定研究支持（PSRS）提供。这一资源发挥了 在为新的R01和P01提案提供初步数据方面发挥重要作用。这些协议都受到 由临床方案审查和监查委员会（CPRMC）进行审查，如PRMS所述 科.为PSRS工作人员提供的资金将为癌症中心提供稳定的核心专家工作人员， 高素质，以支持创新，短期可行性研究的开展和完成， COHCCC计划由PSRS支持的研究是项目的基础， 血液系统恶性肿瘤、发育性癌症治疗和癌症免疫治疗。更 在过去的一年里，这三个项目每年有500多名患者参加治疗性临床试验， 补助金周期; 2006财政年度，这一累积增长到652名患者参加了治疗试验。应计至 制药商发起的COH申办的试验（没有其他同行评审的支持来源）占34% 2006财政年度参与干预性试验的患者数量。使用的优先次序 PSRS提供的资源（以及预算监督）最初在临床 研究项目本身，然后由临床研究管理机构提供的审查 董事会由罗伯特·菲格林博士担任主席。对参与这些试验的CRA的监督发生在几个层面上 包括临床研究项目负责人、方案主要研究者和 临床方案管理核心（CPMC）培训和质量保证过程。所有CRA 从CCSG请求的支持协议特定研究的数据库是更大的集中式数据库的一部分， 由CPMC监督和管理的CRA。请求提供资金，以支持3名专职同等人员 （FTE）分布在6个CRA上，以覆盖广泛的试验和项目，同时允许疾病特异性 还重点关注受资助试验的方案管理。这些CRA负责方案 为我们的内部第一阶段和试点研究进行监测、数据收集和数据质量控制。他们帮助 通过在入组前对患者进行合格性检查，确保临床研究的成功， 协助实现应计目标，提供随访并记录准确完整的受试者数据。

The overwhelming majority of patient accrual to City of Hope (COH)-sponsored trials without other sources of peer-reviewed support was to Phase l/ll and pilot trials by COM clinical investigators. This was made possible by the protocol specific research support (PSRS) of the CCSG. This resource has played an important role in providing preliminary data for new R01 and P01 proposals. These protocols all are subject to review by the Clinical Protocol Review and Monitoring Committee (CPRMC), as described under the PRMS section. Funding for the PSRS staff will provide the Cancer Center with a stable core of expert staff who are highly qualified to support the conduct and completion of innovative, short-term feasibility studies originating from COHCCC Programs. The studies supported by PSRS are the foundation of the programs in Hematologic Malignancies, Developmental Cancer Therapeutics and Cancer Immunotherapeutics. More than 500 patients per year were accrued to therapeutic clinical trials by these three programs over the last grant cycle; in FY 2006 this accrual grew to 652 patients enrolled on therapeutic trials. Accrual to investigator-initiated, COH-sponsored trials (without other peer-reviewed sources of support) comprised 34% of the patient volume enrolled onto interventional trials in FY 2006. The prioritization of the usage of the resources provided by PSRS (and the oversight of the budget) is performed initially within the clinical research programs themselves and then by the review provided by the Clinical Research Governance Board, chaired by Dr. Robert Figlin. Oversight of the CRAs involved in these trials occurs at several levels including that provided by the clinical research program leaders, the protocol Principal Investigators, and by the Clinical Protocol Management Core (CPMC) training and quality assurance process. All of the CRAs requested in support of protocol specific research from the CCSG are part of the larger, centralized pool of CRAs overseen and administered by the CPMC. Funding is requested to support three full-time equivalents (FTEs) spread over 6 CRAs to cover the broad spectrum of trials and programs, while allowing diseasespecific focus for protocol management of funded trials as well. These CRAs are responsible for protocol monitoring, data collection and data quality control for our in-house Phase I and pilot studies. They help ensure the success of the clinical studies by providing eligibility checks of patients prior to enrollment, assisting in meeting accrual goals, providing follow-up and recording accurate complete subject data.