Protocol Specific Research

协议特定研究

• 批准号: 8182242
• 负责人: THEODORE G KRONTIRIS
• 金额: $ 16.22万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8182242
• 关键词: Protocol; Specific; Research

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.

绝大多数患者在没有其他来源的情况下参加了希望之城 (COH) 赞助的试验 同行评审支持主要针对 COM 临床研究人员进行的 I/II 期试验和试点试验。这是做了 通过 CCSG 的协议特定研究支持 (PSRS) 可以实现。该资源起到了 在为新的 R01 和 P01 提案提供初步数据方面发挥着重要作用。这些协议均受 由临床方案审查和监测委员会 (CPRMC) 进行审查，如 PRMS 中所述 部分。对 PSRS 工作人员的资助将为癌症中心提供稳定的核心专家人员，他们 具有高素质支持开展和完成创新性短期可行性研究 来自 COHCCC 计划。 PSRS 支持的研究是该项目的基础 血液恶性肿瘤、发育性癌症治疗和癌症免疫治疗。更多的 过去，这三个项目每年吸引超过 500 名患者参加治疗性临床试验 拨款周期； 2006 财年，参加治疗试验的患者人数增至 652 名。应计至 研究者发起、COH 赞助的试验（没有其他同行评审的支持来源）占 34% 2006 财年参加介入试验的患者数量。 PSRS 提供的资源（以及预算监督）最初是在临床 研究计划本身，然后由临床研究治理提供的审查 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 的监督发生在多个层面 包括临床研究项目负责人、方案首席研究员以及 临床方案管理核心 (CPMC) 培训和质量保证流程。所有 CRA 为支持 CCSG 协议特定研究而请求的请求是更大的集中式数据库的一部分 CRA 由 CPMC 监督和管理。请求资金支持三名全职同等人员 (FTE) 分布于 6 个 CRA，以涵盖广泛的试验和项目，同时允许特定疾病 还重点关注资助试验的方案管理。这些 CRA 负责协议 我们内部第一阶段和试点研究的监测、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资格检查来确保临床研究的成功， 协助实现应计目标，提供后续行动并记录准确的完整受试者数据。