Core 3: Communications, Administrations, Advocacy, and Project Management

核心 3：沟通、行政、宣传和项目管理

• 批准号: 10628613
• 负责人: LAURA J ESSERMAN
• 金额: $ 26.66万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-08 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10628613
• 关键词: Achievement; Advocacy; Advocate; Breast Cancer Treatment; Budgets; Clinical; Clinical Drug Development; Collaborations; Communication; Elements; Ensure; Friends; Generations; Goals; Human Resources; Individual; Infrastructure; Leadership; Magnetic Resonance Imaging; Measurable; Measures; Methodology; Modification; Office of Administrative Management; Outcome; Participant; Patient-Focused Outcomes; Patients; Program Research Project Grants; Protocols documentation; Regimen; Regulatory Pathway; Reporting; Research Personnel; Role; Science; Sequential Treatment; Specific qualifier value; Structure; Subgroup; Training; Translating; Translational Research; Work; design; imaging biomarker; improved; malignant breast neoplasm; meetings; molecular marker; next generation; novel; operation; personalized medicine; programs; response biomarker; restraint; timeline; tool; treatment response; treatment strategy; trial design; webinar; working group

The Program Project encompasses four integrated projects to develop and maintain the infrastructure for developing and implementing improvements in the I-SPY2.2 trial that employs early escalation/de-escalation of treatment and identifies treatment strategies to optimize patient outcomes within a regulatory evidence generation framework. The primary aims of the Communications, Administration, Advocacy, and Project management (CAAP) Core are to ensure program integration, collaboration, patient acceptance, and regulatory compliance by providing project management, leadership, and administrative support to all Projects and Cores; as well as the integration of advocacy in all patient-facing aspects of the Projects and Core in the Program Project. Perhaps the most critical role of the CAAP core is to coordinate the activities and deliverables of the projects and cores with the study sponsor QLHC, its clinical operations team and the I-SPY2 trial working group chairs. While program project personnel, cores and projects are tasked with developing and refining the technical and methodological advances required in the continuous improvement approach employed in I-SPY2.2, all operational aspects of the trial are the responsibility of the study sponsor. The Program Project overall PIs and project PIs, facilitated by the CAAP core, work to integrate the changes into the operations of the trial with sponsor representatives by defining the technical requirements, specifications, and deliverables for the sponsor’s clinical operations team. Among its other responsibilities, the CAAP Core ensures that our patient advocates are represented on all project teams, cores teams and inter-project collaborations, so that they can bring their unique and important perspective to help meet the patient-centric mandate of I-SPY2.2. Specific Aim 1: Organize, integrate, and provide administrative management of all Projects and Core Specific Aim 2: Provide project management oversight to track milestones and timelines of the individual Projects and Cores. Specific Aim 3: Facilitate collaborations and disseminate information

该计划项目包括四个综合项目，以开发和维护基础设施， 在I-SPY 2.2试验中实施改进，该试验采用早期升级/降级治疗，并确定 在监管证据生成框架内优化患者结局的治疗策略。主要目标 沟通、行政、宣传和项目管理（CAAP）核心的目的是确保项目 整合、协作、患者接受度和法规遵从性，提供项目管理、领导力， 为所有项目和核心提供行政支持;以及将宣传纳入所有面向患者的方面， 项目和核心项目。 CAAP核心最关键的作用可能是协调项目和核心的活动和交付成果 与研究申办者QLHC、其临床运营团队和I-SPY 2试验工作组主席一起。尽管程序 项目人员、核心和项目的任务是开发和完善技术和方法方面的进展 根据I-SPY 2.2中所采用的持续改进方法的要求，试验的所有操作方面都是 研究申办者的责任。在CAAP核心的推动下， 与申办者代表一起，通过定义技术 申办者临床运营团队的要求、质量标准和可交付成果。 在其其他职责中，CAAP核心确保我们的患者倡导者在所有项目团队中都有代表， 核心团队和项目间合作，以便他们能够带来独特而重要的观点，以帮助满足 以病人为中心的I-SPY 2.2. 具体目标1：组织、整合并提供所有项目和核心项目的行政管理 具体目标2：提供项目管理监督，以跟踪各个项目的里程碑和时间表， 丹 具体目标3：促进合作和传播信息