North American Star Consortium

该UM1续订申请被指定为北美明星联盟(NASC)，该联盟包括 莫菲特癌症中心(MCC)为牵头学术组织(LAO)，丹尼尔·沙利文(Daniel Sullivan)为医学博士 联系派。加入MCC的还有包括玛格丽特公主在内的四个卓有成效的学术组织 癌症中心(PMCC；菲利普·贝达德，医学博士，多PI)，弗吉尼亚联邦大学梅西癌症 德克萨斯大学西南部西蒙斯癌症中心(VCU-Massey；Steven Grant，医学博士，多PI) 和西北卢里癌症中心(西北大学；马里兰州杰弗里·索斯曼，马里兰州杰弗里·索斯曼， 多PI)。NASC是从公主玛格丽特第一阶段财团(PMP1C)演变而来的，其中PMCC是 老挝和MCC以及VCU-Massey的首席执行官。两个新站点(UTSW和NWU)带来了更多的深度 基础/翻译科学和生物标记物(BM)开发，有活跃的早期临床试验计划， 优先考虑少数族裔患者的收益，为早期职业临床提供积极的指导计划 调查人员(ECI)，并扩大NASC在调查成像方面的专业知识。PMP1C从 2014年4月至今，在此期间，已经启动了14项ETCTN试验，4项正在进行中 激活。在此期间，平均每年累积52名患者(年度目标是50名患者/年)， 共有97名患者入选，2018年3月至2019年2月。NASC的5所院校共招收1703人 参加他们的前50名试验(ETCTN+非ETCTN)的患者，有适当的少数患者应得收益，例外 对ECI的强大指导，以及对整合和探索性BM的重要相关分子分析。 PMP1C和UTSW/西北部大学的这种生产力现在将与MCC作为LAO进行合作，以解决 遵循特定的目标。1.计划、开发和激活新的第一阶段和第二阶段ETCTN试验 参加项目组成员申请机制或作为调查员发起的试验(IITs) 来自NASC的调查人员。NASC的目标是每年至少启动6次试验。2.入学 来自NASC或其他需要获取高质量肿瘤组织的ETCTN试验的患者 对于生物标志物和药效学分析，包括药代动力学(PK)终点，并密切跟踪 良好的临床实践和人体主体保护指南。美国国家会计准则委员会关于ETCTN的年度应计目标 试验每年至少有100名患者(MCC 30名，PMCC和VCU-Massey各20名，VCU-Massey各15名 南加州大学和西北部大学)。3.通过提供教育，专注于NASC内ECI的职业发展 5个机构有关临床研究及其监管的机会，让ECI担任 ETCTN研究的PI，并将他们与高级调查员导师配对，并通过专注于ECI暴露和 生物标志物、相关分子分析、PK研究和精确癌症医学方面的教育。4. 为了确保在NASC地点进行的ETCTN试验有适当的少数族裔患者收益，其他 服务不足的人群、青少年和年轻人、老年人和农村人口。

This UM1 renewal application is designated the North American Star Consortium (NASC), which includes Moffitt Cancer Center (MCC) as the Lead Academic Organization (LAO) with Daniel Sullivan, MD as the contact PI. MCC is joined by four highly productive Academic Organizations (AO) including Princess Margaret Cancer Center (PMCC; Philippe Bedard, MD, multi-PI), Virginia Commonwealth University-Massey Cancer Center (VCU-Massey; Steven Grant, MD, multi-PI), University of Texas Southwestern Simmons Cancer Center (UTSW; Muhammad Beg, MD, multi-PI), and Northwestern Lurie Cancer Center (NWU; Jeffrey Sosman, MD, multi-PI). The NASC evolved from the Princess Margaret Phase 1 Consortium (PMP1C), where PMCC was the LAO and MCC and VCU-Massey AOs. The two new sites (UTSW and NWU) bring additional depth in basic/translational science and biomarker (BM) development, have active early phase clinical trial programs, prioritize the accrual of minority patients, have active mentorship programs for Early Career Clinical Investigators (ECIs), and expand the NASC expertise in investigational imaging. The PMP1C has existed from April 2014 to the present and during this time 14 ETCTN trials have been activated and 4 are pending activation. The average yearly accrual during this time was 52 patients/year (yearly goal was 50 patients/year), with 97 patients enrolled March 2018 – February 2019. The 5 NASC institutions have enrolled a total of 1703 patients on their “top 50 trials” (ETCTN + non-ETCTN) with appropriate minority patient accrual, exceptionally strong mentoring of ECIs, and significant correlative molecular analyses for integrated and exploratory BM. This productivity of the PMP1C and UTSW/NWU will now go forward with MCC as the LAO to address the following specific aims. 1. To plan, develop, and activate novel phase 1 and phase 2 ETCTN trials through participation in the Project Team Member Application mechanism or as investigator-initiated trials (IITs) that emerge from NASC investigators. The NASC goal is to activate a minimum of six trials/year. 2. To enroll patients on ETCTN trials from the NASC or other sites that require the acquisition of high-quality tumor tissue for biomarker and pharmacodynamic analyses, include pharmacokinetic (PK) endpoints, and closely follow Good Clinical Practice and Human Subject Protection guidelines. The NASC annual accrual goal on ETCTN trials is a minimum of 100 patients/year (30 at MCC, 20 each at PMCC and VCU-Massey, and 15 each at UTSW and NWU). 3. To focus on the career development of ECIs within the NASC by providing educational opportunities regarding clinical research and its regulation at the 5 institutions, by having the ECI serve as the PI of ETCTN studies and pairing them with senior investigator mentors, and by focusing on ECI exposure and education regarding biomarkers, correlative molecular analyses, PK studies and precision cancer medicine. 4. To ensure that ETCTN trials performed at NASC sites have appropriate accrual of minority patients, other underserved populations, adolescent and young adults, the elderly, and rural populations.