Core--Protocol Specific Research Support

核心——协议特定研究支持

• 批准号: 7038859
• 负责人: JOHN C RUCKDESCHEL
• 金额: $ 5.18万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7038859
• 关键词: biomedical facility; cancer registry /resource; clinical trial phase I; clinical trial phase II; clinical trials; data collection; data management; health science research analysis /evaluation; imaging /visualization /scanning; medical outreach /case finding; neoplasm /cancer

The Protocol-Specific Research Support (PSRS) is an effort to expand the number of investigator-initiated clinical trials at KCI. Support must be available to conduct preliminary studies, most of which are not presently funded by the NCI or other agencies. The purpose of the PSRS is to provide an administrative support mechanism to provide data management, collection of patient data, and to support innovative clinical trials within the Cancer Center. The objective is to foster investigator-initiated trials, which bring new results from our basic science laboratories to the clinical and population studies arenas. The awarding of PSRS to an investigator is done at the recommendation of the Scientific Leadersip Council. Associate center directors, Program leaders, or heads of the Multidisciplinary Teams can nominate protocols for support. Proposals are evaluated for their scientific merit and importance in developing new avenues of research within the Cancer Center. Although all proposals are given serious consideration, studies that show the potential to develop new avenues of research and secure external funding are encouraged. There are many investigator-initiated translational studies within the Cancer Center. These include novel and molecular targeted therapies, and functioning imaging techniques. These trials seek to test new, targeted therapies both as single agents, and in combination with more established cytotoxic therapy. They often include measurements of treatment effect based on blood samples and tumor biopsies. New imaging approaches are integral to this work as they provide a noninvasive way to test these treatment approaches. For the future, we plan to support a mixture of Phase I, Phase II, and imaging/correlative trials. Funding support for 1.5 FTE data management to support the innovative trials is requested. Data management will include confirming patient eligibility prior to registration to the trial, abstracting and collating data from various sources ensuring that qualtiy control checks are being conducted.

特定方案研究支持 (PSRS) 旨在扩大 KCI 研究者发起的临床试验的数量。必须为开展初步研究提供支持，其中大部分研究目前尚未得到 NCI 或其他机构的资助。 PSRS 的目的是提供行政支持机制，以提供数据管理、患者数据收集，并支持癌症中心内的创新临床试验。目标是促进研究者发起的试验，将我们的基础科学实验室的新结果带到临床和人口研究领域。 PSRS 授予研究者是根据科学领导委员会的建议进行的。副中心主任、项目负责人或多学科团队负责人可以提名协议以获得支持。评估提案的科学价值和在癌症中心开发新研究途径方面的重要性。尽管所有提案都会得到认真考虑，但鼓励那些显示出开发新研究途径和确保外部资金潜力的研究。癌症中心内有许多研究者发起的转化研究。其中包括新颖的分子靶向疗法以及功能成像技术。这些试验旨在测试新的靶向疗法作为单一药物， 并与更成熟的细胞毒疗法相结合。它们通常包括基于血液样本和肿瘤活检的治疗效果测量。新的成像方法是这项工作不可或缺的一部分，因为它们提供了一种非侵入性的方法来测试这些治疗方法。 未来，我们计划支持 I 期、II 期和成像/相关试验的混合。 请求为 1.5 FTE 数据管理提供资金支持，以支持创新试验。数据管理将包括在注册试验之前确认患者的资格，从各种来源提取和整理数据，确保进行质量控制检查。