EARLY PHASE CLINICAL RESEARCH SUPPORT (Core 018)

早期临床研究支持（核心 018）

• 批准号: 9114521
• 负责人: Hussein A. Tawbi
• 金额: $ 10.19万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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/9114521
• 关键词: Area; Biological Markers; Cancer Center Support Grant; Clinical; Clinical Investigator; Clinical Nursing Research; Clinical Research; Clinical Trials; Clinical Trials Design; Collection; Data; Development; Devices; Disease; Drug Kinetics; Funding; Head and Neck Cancer; Image; Immunologic Monitoring; Immunologist; Institution; Investigational Therapies; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of ovary; Medical; Monitor; New Agents; Pharmacodynamics; Phase; Phase I Clinical Trials; Procedures; Research; Research Personnel; Research Support; Science; Scientist; Tissue Banking; Tissue Banks; Translating; University of Pittsburgh Cancer Institute; Work; abstracting; analytical method; cancer clinical trial; design; experience; imaging modality; innovation; malignant breast neoplasm; melanoma; member; molecular diagnostics; molecular marker; pharmacodynamic biomarker; phase 2 study; pre-clinical; programs; radiologist; tumor

Abstract: Early Phase Clinical Research Support (EPCRS Early Phase Clinical Research Support (EPCRS) provides funding for dedicated clinical research nurse and data manager support for the coordination and implementation of innovative, proof-of-principle early phase clinical trials initiated by UPCI members. A major objective of the current project period was to continue to develop a robust Phase I clinical trials program that translates the strong science being conducted in the various UPCI research programs. Of note, the UPCI Phase I Team has worked closely with the UPCI CCSG disease-oriented programs, including Breast and Ovarian Cancer, Head and Neck Cancer, Lung Cancer, and Melanoma to prioritize, design, develop, and implement innovative phase I clinical trials with incorporation of important correlative science biomarkers. The specific aims of EPCRS are to: (1) Continue to expand UPCI’s phase I clinical trials portfolio through support of innovative, proof-of-principle cancer studies to evaluate new agents, medical procedures, and devices in order to provide the data necessary to apply for funding of later phase studies; (2) Stimulate new and collaborative early phase clinical trials across the UPCI research programs; and (3) Incorporate correlative pharmacodynamic biomarkers and imaging into early phase clinical trials. The UPCI Phase I Team is deeply committed to using a team science approach in the development of new investigational agents. This team science approach is best highlighted in the membership of the team, which has significantly grown since the 2010 CCSG review to now include expertise covering the entire range of experimental therapeutics, pre-clinical basic scientists, clinical investigators, translational scientists, clinical pharmacologists focused on pharmacokinetics (PK)/pharmacodynamics (PD), immunologists focused on immune monitoring, radiologists specializing in tumor assessment and development of imaging modalities, and statistical expertise in early-phase clinical trial design along with analytical methods to assess conventional clinical endpoints with sophisticated biomarker and molecular data. In addition, the Phase I Team has taken full advantage of the extensive experience of UPCI and the institution as it relates to tumor collection and tissue banking, and in the area of tumor characterization using sophisticated, state-of-the-art molecular diagnostics.

摘要：早期临床研究支持（EPCRS 早期临床研究支持（EPCRS）为专门的临床研究护士提供资金， 数据管理员支持创新的、原理验证的早期阶段的协调和实施 由UPCI成员发起的临床试验。本项目期间的一个主要目标是继续 制定一个强有力的I期临床试验计划，将正在进行的强有力的科学转化为 UPCI的各种研究项目。值得注意的是，UPCI第一阶段团队与UPCI CCSG密切合作， 以疾病为导向的计划，包括乳腺癌和卵巢癌，头颈癌，肺癌， 黑色素瘤优先考虑，设计，开发和实施创新的I期临床试验， 重要的相关科学生物标志物。EPCRS的具体目标是：（1）继续扩大UPCI的 I期临床试验组合，通过支持创新的、原理证明的癌症研究， 代理人，医疗程序和设备，以便提供申请资金所需的数据， （2）在UPCI研究中促进新的和合作的早期临床试验 （3）将相关的药效学生物标志物和成像纳入早期临床研究。 审判UPCI第一阶段团队致力于使用团队科学方法开发 新的研究药物。这种团队科学方法在团队成员中得到了最好的体现， 自2010年CCSG审查以来，该公司已大幅增长，现在包括涵盖整个范围的专业知识 实验治疗学，临床前基础科学家，临床研究者，转化科学家，临床 药理学家专注于药代动力学（PK）/药效学（PD），免疫学家专注于 免疫监测，专门从事肿瘤评估和成像模式开发的放射科医生，以及 沿着早期临床试验设计统计学专业知识和分析方法， 具有复杂生物标志物和分子数据的临床终点。此外，第一阶段工作队已全面 UPCI和机构在肿瘤采集和组织方面的丰富经验的优势 银行，并在肿瘤表征领域使用复杂的，国家的最先进的分子诊断。