EARLY PHASE CLINICAL RESEARCH SUPPORT (Core 018)

摘要：早期临床研究支持(EPCRS) 早期临床研究支持(EPCRS)为专职的临床研究护士和 为协调和实施创新的原则验证早期阶段提供数据管理员支持 由UPCI成员发起的临床试验。当前项目期的一个主要目标是继续 制定强有力的I期临床试验计划，将在 各种UPCI研究项目。值得注意的是，UPCI第一阶段团队与UPCICCSG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、肺癌和 黑色素瘤将优先考虑、设计、开发和实施创新的I期临床试验，并纳入 重要的相关科学生物标志物。EPCRS的具体目标是：(1)继续扩大UPCIs 通过支持创新的、原则证明的癌症研究来评估新的 代理人、医疗程序和设备，以便提供必要的数据，以便以后申请资金 阶段研究；(2)在UPCI研究中激发新的和协作的早期临床试验 计划；以及(3)将相关的药效学生物标志物和成像技术纳入早期临床 审判。UPCI第一阶段团队致力于使用团队科学的方法来开发 新的调查员。这种团队科学方法在团队成员中得到了最好的强调， 自2010年CCSG审查以来显著增长，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，临床研究人员，转化科学家，临床 药理学家侧重于药代动力学(PK)/药效学(PD)，免疫学家侧重于 免疫监测，专门从事肿瘤评估和成像方式开发的放射科医生，以及 早期临床试验设计的统计专业知识以及评估常规临床试验设计的分析方法 具有复杂生物标记物和分子数据的临床终端。此外，一期车队已经满员。 UPCI和该机构在肿瘤收集和组织方面的丰富经验的优势 在银行业，以及在使用尖端的最先进的分子诊断技术的肿瘤表征领域。

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.