CORE--PROTOCOL-SPECIFIC RESEARCH

议定书具体研究核心设施将为进行创新的第一阶段和第二阶段临床试验提供熟练和专门的研究护理支助(3 FTE)。这些试验将是a)具有很强相关性的科学和/或药代动力学和药效学成分的复杂性，b)由UNC LCCC研究人员发起的，以及c)主要基于UNC LCCC成员的科学专业知识和兴趣。试验将从提交给中国审查的新颖性、复杂性和治疗益处的承诺中挑选出来。学院顾问贝弗利·米切尔博士与谢伊博士和 戈德伯格是临床研究计划的联合负责人，他将负责试验的选择和每月对应计项目的监测，以及相关研究的使用和质量。过去五年的进步标志着许多创新研究的成功进行，包括PS341(Bortezomib)治疗难治性多发性骨髓瘤的开创性I期研究，Bortezomib与其他细胞毒剂联合治疗实体瘤和难治性血液系统恶性肿瘤的多项I期研究，以及使用定制设计以增强免疫反应的HER2 neu肽治疗转移性乳腺癌的新型树突状细胞疫苗研究。该计划的预期增长是基于类似的 正在开发或最近启动的研究。越来越多有才华的年轻临床医生 研究人员的增长、分子治疗计划和临床研究计划开发治疗学重点的增长，以及北卡罗来纳大学LCCC领导层对开发以分子相关性或终点为战略方向的新型治疗方法的坚定承诺，创造了一个环境，将在未来五年产生对密集研究护理支持的更强烈需求。预计我们在任何时候都将有大约9个这样的试验开放，平均每年招募100名患者。

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.