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

核心 3：沟通、行政、宣传和项目管理

基本信息

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
项目类别：
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

项目摘要

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，旨在开发和维护开发和维护基础设施在 I-SPY2.2 试验中实施改进，采用早期升级/降级治疗并确定主要目标是在监管证据生成框架内优化患者治疗结果。沟通、行政、宣传和项目管理 (CAAP) 核心的职责是确保计划通过提供项目管理、领导力、整合、协作、患者接受度和法规遵从性，对所有项目和核心的行政支持，以及将宣传整合到所有面向患者的方面；计划项目中的项目和核心。也许 CAAP 核心最关键的作用是协调项目和核心的活动和可交付成果与研究申办者 QLHC、其临床操作团队和 I-SPY2 试验工作组主席 While 项目一起。项目人员、核心和项目的任务是开发和完善技术和方法的进步根据 I-SPY2.2 中采用的持续改进方法的要求，试验的所有操作方面都是该计划的总体 PI 和项目 PI 在 CAAP 核心的推动下发挥作用。通过定义技术，将变更整合到申办者代表的试验操作中申办者临床运营团队的要求、规范和可交付成果。除其他职责外，CAAP 核心还确保我们的患者倡导者在所有项目团队中都有代表，核心团队和项目间协作，以便他们能够带来独特而重要的视角来帮助满足 I-SPY2.2 以患者为中心的任务。具体目标 1：组织、整合并提供所有项目和核心的行政管理具体目标 2：提供项目管理监督，以跟踪各个项目和项目的里程碑和时间表核心。具体目标 3：促进合作和传播信息