CORE--PROTOCOL-SPECIFIC RESEARCH

核心——特定于协议的研究

• 批准号: 7100788
• 负责人: BEVERLY S. MITCHELL
• 金额: $ 14.52万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7100788
• 关键词: biomedical facility; clinical trial phase I; clinical trial phase II; human subject; human therapy evaluation; neoplasm /cancer therapy; oncology nursing

The Protocol Specific Research Core Facility will provide skilled and specialized research nursing support (3 FTEs) for the conduct of innovative Phase I and II clinical trials. These trials will be a) complex with strong correlative science and/or pharmacokinetic and pharmacodynamic components, b) UNC LCCC investigator-initiated, and c) primarily based on scientific expertise and interests ofUNC LCCC members. Trials will be selected from among those submitted to the PRC for review for novelty, complexity, and promise of therapeutic benefit. The Faculty Advisor, Dr. Beverly Mitchell, in direct consultation with Drs. Shea and Goldberg, co-leaders of the Clinical Research Program, will be responsible for the selection of trials and monthly monitoring for accrual and the use and quality of correlative studies. Progress over the last five years has been marked by the successful conduct of a number of innovative studies, including a pioneering Phase I study of PS341 (Bortezomib) in refractory multiple myeloma, a number of Phase I studies of Bortezomib in combination with other cytotoxic agents for solid tumors and refractory hematologic malignancies, and a novel dendritic cell vaccine study in metastatic breast cancer using a HER2 neu peptide custom-designed to enhance the immunologic response. Anticipated growth of the program is predicated on the number of similar studies under development or recently initiated. The increasing number of talented young clinical investigators, the growth of the Molecular Therapeutics Programs and the Clinical Research Program's Developmental Therapeutics focus, and the strong commitment of the UNC LCCC leadership to the development of novel therapeutics with molecular correlates or endpoints as a strategic direction create an environment that will generate even stronger demand for intensive research nursing support over the next five years. It is anticipated that we will have approximately nine such trials open at any given time and enroll an average of 100 patients annually.

方案特定研究核心机构将为开展创新性I期和II期临床试验提供熟练和专业的研究护理支持（3名全职员工）。这些试验将是a）复杂的，具有很强的相关科学和/或药代动力学和药效学成分，B）由CCLCC药物启动，和c）主要基于CCLCC成员的科学专业知识和兴趣。试验将从提交给PRC的试验中选择，以审查其新奇、复杂性和治疗获益的前景。学院顾问，贝弗利米切尔博士，在与谢伊博士直接磋商， Goldberg是临床研究项目的共同负责人，他将负责选择试验，并每月监测相关研究的使用和质量。在过去五年中，成功进行了许多创新研究，包括一项开创性的PS341 I期研究，（硼替佐米）治疗难治性多发性骨髓瘤，硼替佐米与其他细胞毒性药物联合治疗实体瘤和难治性血液恶性肿瘤的多项I期研究，以及转移性乳腺癌中的新型树突状细胞疫苗研究，其使用定制设计的HER 2 neu肽来增强免疫应答。该计划的预期增长是基于类似的数量 正在开发或最近启动的研究。越来越多的年轻临床人才 研究人员的增加，分子治疗计划和临床研究计划的发展治疗重点的增长，以及UMLCCC领导层对开发具有分子相关物或终点的新型治疗方法的坚定承诺，作为战略方向，创造了一个环境，将在未来五年内产生对密集研究护理支持的更强烈需求。预计我们将在任何特定时间开放约9项此类试验，平均每年招募100名患者。