Protocol Specific Research Support
协议特定研究支持
基本信息
- 批准号:7513335
- 负责人:
- 金额:$ 7.26万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2007
- 资助国家:美国
- 起止时间:2007-08-09 至 2012-07-31
- 项目状态:已结题
- 来源:
- 关键词:AddressCancer CenterCancer Center Support GrantClinicalClinical ResearchClinical TrialsCollaborationsComplexDataDevelopmentDevelopmental Therapeutics ProgramDiscipline of NursingDocumentationDrug KineticsElementsEligibility DeterminationEnsureFundingFunding MechanismsGoalsImmunologyImmunotherapyInvestigationLaboratoriesLinkMedical OncologistMissionMonitorNatureNursing ResearchOncologistOperative Surgical ProceduresPatient MonitoringPatient RecruitmentsPharmacodynamicsPhasePhase I Clinical TrialsProtocols documentationRadiation therapyRadiobiologyRateReportingReproduction sporesResearchResearch PersonnelResearch SupportResourcesSafetyScienceServicesSite VisitSkin CancerSourceStructureSupport of ResearchSystemTimeTranslatingTranslational ResearchWorkbasecancer immunotherapycancer preventiondata managementdesigndrug developmentexperienceinnovationmelanomapre-clinicalprogramsquality assurancestemsuccess
项目摘要
The Protocol Specific Research Support (PSRS) funding of the CCSG supports research personnel
dedicated to the development, implementation, conduct, and completion of high priority, innovative
investigator-initiated phase I clinical trials. This resource is of high priority to the Cancer Center given the
renewed and strong commitment to translational research and early phase clinical studies. In particular, this
funding mechanism is critical for the YCC to fulfill its mission of translating the most exciting discoveries and
science coming from YCC research labs into the clinical setting. As such, these types of translational clinical
studies are complex in nature and design, as they incorporate important correlative, biologic,
pharmacokinetic, and pharmacodynamic studies. While the YCC PSRS has always supported investigatorinitiated
studies, the PSRS anticipates a significant increase in investigator-initiated clinical trials during the
next funding period with an increased need to support these investigators. The main goals of the PSRS are
to (1) provide nursing and data management support for investigator-initiated pilot phase I clinical studies, (2)
provide assistance to investigators in the development and start-up of innovative studies, (3) provide
assistance in eligibility determination and recruitment of patients for these clinical studies, (4) ensure the safe
conduct of clinical research by monitoring patients, (5) provide source documentation for timely and
complete entry in the PRS, (6) report study results, and (7) ensure compliance with federal and regulatory
mandates. This effort .will require research nurses and data managers who have experience to ensure the
safety, integrity, and success of these important studies. The continuity of staffing is essential to the success
of studies presently on-going and to those that will be developed in the next funding period. The PSR
interacts closely with the other key elements of the YCC clinical trials program, which include the Clinical
Research Services (CRS) and the Protocol Review and Monitoring System (PRMS), and working together in
an integrated, highly coordinated manner, these 3 elements serve as the cornerstone for the YCC clinical
investigations program, The PSRS also interacts closely with the YCC Clinical/Translational Research
Programs, including Developmental Therapeutics (DT), Radiobiology & Radiotherapy (R&R), and
Immunology & Immunotherapy (l&l). The SPORE in Skin Cancer with a special focus on melanoma
showcases the highly interdisciplinary, interprogrammatic collaborations between the DT, l&l, and Cancer
Prevention and Control Programs and highlights the focus on developing innovative clinical studies that stem
directly from YCC pre-clinical laboratory investigation.
CCSG 的协议特定研究支持 (PSRS) 资金为研究人员提供支持
致力于开发、实施、开展和完成高度优先、创新的项目
研究者发起的 I 期临床试验。鉴于以下情况,该资源是癌症中心的高度优先事项:
对转化研究和早期临床研究重新做出坚定的承诺。特别是,这
资助机制对于 YCC 履行其将最令人兴奋的发现和成果转化的使命至关重要。
来自 YCC 研究实验室的科学进入临床环境。因此,这些类型的转化临床
研究本质上和设计都很复杂,因为它们包含了重要的相关性、生物学、
药代动力学和药效学研究。虽然 YCC PSRS 始终支持调查员发起
研究中,PSRS 预计研究者发起的临床试验将显着增加
下一个资助期,对支持这些研究人员的需求会增加。 PSRS 的主要目标是
(1) 为研究者发起的试点 I 期临床研究提供护理和数据管理支持,(2)
为研究人员开发和启动创新研究提供帮助,(3) 提供
协助确定这些临床研究的资格和招募患者,(4) 确保安全
通过监测患者进行临床研究,(5)提供源文件,以便及时和
完整填写 PRS,(6) 报告研究结果,以及 (7) 确保符合联邦和监管规定
授权。这项工作需要有经验的研究护士和数据管理人员来确保
这些重要研究的安全性、完整性和成功。人员配置的连续性对于成功至关重要
目前正在进行的研究以及将在下一个资助期间开展的研究。 PSR
与 YCC 临床试验计划的其他关键要素密切互动,其中包括临床试验
研究服务(CRS)和方案审查和监测系统(PRMS),并在
这三个要素以综合、高度协调的方式构成了 YCC 临床的基石
调查计划,PSRS 还与 YCC 临床/转化研究密切互动
项目,包括发育治疗 (DT)、放射生物学和放射治疗 (R&R) 以及
免疫学与免疫治疗(l&l)。皮肤癌中的 SPORE,特别关注黑色素瘤
展示了 DT、L&L 和癌症之间高度跨学科、跨项目的合作
预防和控制计划并强调重点发展创新临床研究
直接来自YCC临床前实验室调查。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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RICHARD Leslie EDELSON其他文献
RICHARD Leslie EDELSON的其他文献
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{{ truncateString('RICHARD Leslie EDELSON', 18)}}的其他基金
BASIC AND CLINICAL BIOLOGY OF CUTANEOUS T CELL LYMPHOMA
皮肤 T 细胞淋巴瘤的基础和临床生物学
- 批准号:
6031934 - 财政年份:2000
- 资助金额:
$ 7.26万 - 项目类别:
CONFERENCE: ANTIGEN AND CLONE-SPECIFIC IMMUNOREGULATION
会议:抗原和克隆特异性免疫调节
- 批准号:
3433582 - 财政年份:1990
- 资助金额:
$ 7.26万 - 项目类别:
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