Early Phase Clinical Research Support

早期临床研究支持

• 批准号: 9149096
• 负责人: DARUKA MAHADEVAN
• 金额: $ 12.03万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9149096
• 关键词: Analytical Chemistry; Arizona; Bioinformatics; Biological Markers; Cancer Center; Cancer Center Support Grant; Catchment Area; Chemoprevention; Clinical; Clinical Research; Contracts; Detection; Development; Devices; Drug Kinetics; Funding; Genomics; Goals; Grant; Industry; Laboratories; Malignant Neoplasms; Mentors; Methods; Nurses; Nursing Research; Outcome; Patients; Persons; Phase; Physicians; Prevention; Proteomics; Protocols documentation; Research; Research Personnel; Research Support; Review Committee; Scientist; Specialist; Testing; Therapeutic; Translational Research; Triage; United States National Institutes of Health; Universities; abstracting; base; cancer imaging; cancer therapy; high risk; innovation; meetings; metabolomics; multidisciplinary; novel; operation; pre-clinical; programs; research study

Project Summary / Abstract: Early Phase Clinical Research Support (EPCRS) The goal of the EPCRS Program is to provide critical support to the UACC Early Phase Program (EPP), in which Early Phase trials with the potential for high impact are developed and initiated to provide access to Early Phase research to patients and high-risk persons from the UACC catchment area. The EPP provides support for short-term Pilot (pre-Phase I) and Phase I clinical research studies originating from UACC investigators whose outcomes form the basis of an application for later phase studies through external competitive grants, national group, or industry-sponsored trial support. The Phase I Multi-Disciplinary Team (MDT) manages the overall portfolio of Early Phase research and constitutes the oversight committee that reviews Early Phase research concepts. High priority is given to innovative investigator-initiated trials that focus on initial Early Phase testing of a novel candidate agent, device, or biomarker for the detection, prevention, or treatment of cancer; priority is given to those trials for which the preclinical development of translational science was performed by UACC researchers. The Phase I MDT is comprised of physicians and scientists with expertise in cancer therapeutics and chemoprevention trial development and basic scientists who conduct translational laboratory-based research. Early Phase concepts are further triaged by the Clinical Research Oversight Council, which ultimately ranks trials for EPCRS funding support. The EPP trial development and clinical operations are comprised of a Protocol Writer, Contract Specialist, Regulatory Specialists, Clinical Research Specialists, Research Nurses, a Research Program Manager, a dedicated Early Phase Nurse Navigator, and a Pharmacokinetics Technician. The EPP has conducted a wide range of studies that have led to novel scientific discoveries and to the further development of these discoveries in the context of later phase trials supported by NIH grant mechanisms and industry sponsored trials. A large portfolio of novel Early Phase IITs is currently in development and supported by UACC funding. These trials will utilize a broad range of analytic methods, including genomics, proteomics, metabolomics, analytical chemistry, cancer imaging, and bioinformatics.

项目摘要/摘要：早期临床研究支持 (EPCRS) EPCRS 计划的目标是为 UACC 早期阶段计划 (EPP) 提供关键支持， 开发并启动具有高影响力潜力的早期阶段试验，以提供 针对 UACC 流域地区的患者和高危人群进行早期研究。 EPP 提供 支持源自 UACC 的短期试点（第一阶段前）和第一阶段临床研究 研究人员的结果构成了通过外部进行后期研究申请的基础 竞争性资助、国家团体或行业赞助的试验支持。第一阶段多学科团队 (MDT) 管理早期研究的整体组合并组成监督委员会 回顾早期研究概念。高度优先考虑由研究者发起的创新试验 专注于用于检测的新型候选药物、设备或生物标志物的初始早期阶段测试， 预防或治疗癌症；优先考虑那些临床前开发的试验 转化科学由 UACC 研究人员进行。 I 期 MDT 由医生和 具有癌症治疗和化学预防试验开发专业知识的科学家和基础科学家 他们进行基于实验室的转化研究。早期阶段的概念由临床进一步分类 研究监督委员会，最终对 EPRS 资金支持的试验进行排名。 EPP 审判 开发和临床运营由方案编写者、合同专家、监管专家组成 专家、临床研究专家、研究护士、研究项目经理、专门的早期 阶段护士导航员和药代动力学技术员。 EPP 进行了广泛的研究 带来了新的科学发现，并在背景下进一步发展这些发现 由 NIH 拨款机制和行业赞助的试验支持的后期试验。庞大的投资组合 新颖的早期阶段 IIT 目前正在开发中，并得到 UACC 资金的支持。这些试验将利用 广泛的分析方法，包括基因组学、蛋白质组学、代谢组学、分析化学、癌症 成像和生物信息学。