Protocol Specific Research Support

协议特定研究支持

基本信息

批准号：
8180836
负责人：
JENNIFER A PIETENPOL
金额：
$ 25.87万
依托单位：
VANDERBILT UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-10 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8180836
关键词：
Antineoplastic Agents Area Budgets Cancer Center Cancer Center Support Grant Clinical Trials Commit Committee Members Correlative Study Data Analyses Development Discipline Disorder by Site Doctor of Medicine Eastern Cooperative Oncology Group Effectiveness Electronics Elements Evaluation Faculty Funding Future Goals Grant Growth Hematology Human Resources Investigation Label Laboratories Lead Malignant Neoplasms Medical Oncology Medicine Microbubbles Mission Monitor New Agents Online Systems Outcome Pediatric Oncologist Peer Review Phase Phase I Clinical Trials Phase III Clinical Trials Pilot Projects Preparation Principal Investigator Process Protocols documentation Qualifying Radiation Oncology Recruitment Activity Research Research Personnel Research Support Resource Allocation Resource Sharing Resources Schedule Secure Solid Neoplasm Surgical Oncology The Vanderbilt-Ingram Cancer Center at the Vanderbilt University Time Translational Research Translations Ultrasonography Universities Voting Work base career development design drug discovery high throughput screening inhibitor/antagonist innovation meetings novel oncology originality phase 1 study pilot trial pre-clinical programs tool web site

项目摘要

The purpose of Protocol Specific Research Support (PSRS) is to help VICC continue its commitment to high quality, scientifically meritorious translational research intended to lead to further trials and/or to lead to peer-reviewed support. The Resource Allocation Committee (RAC) distributes these important funds to deserving clinical trials. James Whitlock, M.D., a pediatric oncologist, chairs the RAC, which includes the VICC Director and Deputy Director along with representatives from Medical Oncology, Surgical Oncology, and Radiation Oncology. Investigator-initiated feasibility/Phase I or pilot trials are judged for scientific merit based on an independent internal or external scientific review. The criteria include whether the trial originates from preclinical work performed within the VICC, the potential to lead to external peer-reviewed funding, the potential to lead to a larger multi-institutional pivotal Phase 11 or Phase 111 trial, or whether the trial has unique laboratory correlates integrated into its primary or secondary aims/objectives. Career development goals (preferential consideration for junior faculty) are also considered. During the last grant cycle, the VICC committed philanthropy funds to supplement the PSRS funds broadening RAC's ability to support trials that have limited grant support and to fund some correlative studies for exploratory analysis. Full review for both types of funds are carried out in at least quarterly meetings, with ad hoc meetings held based on need. Preparation of an information packet including the protocol, its relevance, budget shortfall and rationale, and future directions can be performed from the web-based tool for RAC submission and funds are available to all VICC investigators. In the last grant cycle, 13 trials qualified for PSRS funds, four of which are still open, one closed early, three were not recommended for further development, one led to a phase 11 trial that received pilot funding (also from RAC), one has a further LOI, one is now part of an ECOG trial and two are awaiting final data analysis. There are currently eight trials studying five disease sites under consideration for PSRS funding, including two trials developed by trainees. Thus, PSRS funding is crucial to the translational research work done at Vanderbilt. We have been successful at funding pilot studies and in the next grant cycle anticipate continuing to fund high-impact investigator initiated trials.

协议特定研究支持 (PSRS) 的目的是帮助 VICC 继续致力于高质量、有科学价值的转化研究，旨在带来进一步的试验和/或获得同行评审的支持。资源分配委员会 (RAC) 将这些重要资金分配给值得进行的临床试验。儿科肿瘤学家 James Whitlock 医学博士担任 RAC 主席，该委员会包括 VICC 主任和副主任以及来自肿瘤内科、肿瘤外科和放射肿瘤科的代表。根据独立的内部或外部科学审查，对研究者发起的可行性/第一阶段或试点试验的科学价值进行判断。标准包括试验是否源自 VICC 内进行的临床前工作、获得外部同行评审资金的潜力、导致更大规模的多机构关键 11 期或 111 期试验的潜力，或者试验是否具有独特性。实验室相关性融入其主要或次要目的/目标。职业发展目标（优先考虑初级教师）也被考虑在内。在上一个拨款周期中，VICC 承诺提供慈善资金来补充 PSRS 资金，从而扩大 RAC 的能力，以支持拨款支持有限的试验，并资助一些用于探索性分析的相关研究。两类基金至少每季度进行一次全面审查，并根据需要召开临时会议。可以通过基于网络的 RAC 提交工具准备信息包，包括方案、其相关性、预算缺口和理由以及未来方向，并且所有 VICC 调查人员均可获得资金。在上一个拨款周期中，有 13 项试验符合 PSRS 资金资格，其中 4 项仍在开放，1 项提前结束，3 项不建议进一步开发，1 项进入 11 期试验并获得试点资金（也来自 RAC），1 项有进一步的意向书，其中一项现已成为 ECOG 试验的一部分，两项正在等待最终数据分析。目前有八项研究五个疾病部位的试验正在考虑接受 PSRS 资助，其中包括两项由学员开发的试验。因此，PSRS 资金对于范德堡大学的转化研究工作至关重要。我们已经成功地资助了试点研究，并在下一个资助周期中预计将继续资助高影响力的研究者发起的试验。