Protocol Specific Research Support
Protocol Specific Research Support
批准号:
8180836
负责人:
JENNIFER A PIETENPOL
金额:
$25.87万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2010
资助国家:
美国
项目状态:
已结题
起止时间:
2010-09-10 至 2015-08-31
关键词:
Antineoplastic AgentsAreaBudgetsCancer CenterCancer Center Support GrantClinical TrialsCommitCommittee MembersCorrelative StudyData AnalysesDevelopmentDisciplineDisorder by SiteDoctor of MedicineEastern Cooperative Oncology GroupEffectivenessElectronicsElementsEvaluationFacultyFundingFutureGoalsGrantGrowthHematologyHuman ResourcesInvestigationLabelLaboratoriesLeadMalignant NeoplasmsMedical OncologyMedicineMicrobubblesMissionMonitorNew AgentsOnline SystemsOutcomePediatric OncologistPeer ReviewPhasePhase I Clinical TrialsPhase III Clinical TrialsPilot ProjectsPreparationPrincipal InvestigatorProcessProtocols documentationQualifyingRadiation OncologyRecruitment ActivityResearchResearch PersonnelResearch SupportResource AllocationResource SharingResourcesScheduleSecureSolid NeoplasmSurgical OncologyThe Vanderbilt-Ingram Cancer Center at the Vanderbilt UniversityTimeTranslational ResearchTranslationsUltrasonographyUniversitiesVotingWorkbasecareer developmentdesigndrug discoveryhigh throughput screeninginhibitor/antagonistinnovationmeetingsnoveloncologyoriginalityphase 1 studypilot trialpre-clinicalprogramstoolweb site
中文摘要
方案特定研究支持(PSRS)的目的是帮助VICC继续致力于高质量,科学上有价值的转化研究,旨在导致进一步的试验和/或导致同行评审的支持。资源分配委员会(RAC)将这些重要的资金分配给值得的临床试验。James Whitlock,医学博士,儿科肿瘤学家,RAC主席,包括VICC主任和副主任以及内科肿瘤学、外科肿瘤学和放射肿瘤学的代表。研究者发起的可行性/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科学价值的。这些标准包括试验是否来源于临床前工作,是否有可能获得外部同行评议资金,是否有可能开展更大规模的多机构关键11期或111期试验,或者该试验是否具有独特的实验室相关性,并将其纳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。
英文摘要
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.
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