Protocol Specific Research Support

协议特定研究支持

• 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
• 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

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.

议定书特定研究支持(PSR)的目的是帮助VICC继续致力于高质量、具有科学价值的翻译研究，旨在导致进一步的试验和/或导致同行审查的支持。资源分配委员会(RAC)将这些重要的资金分配给值得进行的临床试验。儿科肿瘤学家詹姆斯·惠特洛克是RAC的主席，RAC的成员包括VICC主任和副主任以及来自内科肿瘤学、外科肿瘤学和放射肿瘤学的代表。调查员发起的可行性/第一阶段或试点试验是根据独立的内部或外部科学审查来判断其科学价值的。这些标准包括试验是否源于VICC内开展的临床前工作、导致外部同行评审资金的可能性、导致更大规模的多机构关键11期或111期试验的可能性，或者试验是否具有与其主要或次要目标/目标相结合的独特实验室相关性。职业发展目标(初级教师优先考虑)也被考虑。 在上一个赠款周期中，VICC承诺提供慈善基金来补充PSRS基金，以扩大RAC支持赠款支持有限的试验的能力，并资助一些用于探索性分析的相关研究。对这两类基金的全面审查至少每季度举行一次会议，并根据需要举行特别会议。编写一份信息包，包括议定书、其相关性、预算缺口和理由，以及未来的方向，可以通过基于网络的RAC提交工具进行，所有VICC调查人员都可以获得资金。在上一个赠款周期，有资格获得PSRS资金的13项试验，其中4项仍然开放，1项提前关闭，3项不建议进一步发展，1项导致第11阶段试验获得试点资金(也来自RAC)，1项有进一步的意向书，1项现在是经社理事会试验的一部分，2项正在等待最终数据分析。目前有八项试验正在研究五个疾病地点，正在考虑为PSRS提供资金，其中包括两项由受训人员开发的试验。因此，PSRS的资金对范德比尔特所做的翻译研究工作至关重要。我们已经成功地资助了试点研究，在下一个赠款周期中，我们预计将继续资助高影响力的调查员发起的试验。