Core 03 - Leadership and Administration

摘要-核心3 该方案项目包括四个单独的项目，它们将：实施循证顺序 预测对初始治疗反应不足的患者的多种治疗分配策略 新辅助靶向和/或化疗(项目1)；确定用于确定的合格非侵入性成像指标 无应答标记(项目2)；确定无应答患者的生物学特征以指导治疗选择 (项目3)；并开发一系列代理和决策工具，用于与以下匹配的治疗重新分配 无反应肿瘤生物学(项目4)。 领导力和管理核心的主要目标是确保计划集成、协作 通过提供项目管理领导和行政支持，促进 三个领域的项目和核心： 目标1：为所有项目和核心提供项目管理和行政监督。 目标2：协调科学会议以及定期网络和视频会议，以促进整个项目 交流、科学互动和监管科学的进步。 目标3：充当通往现有i-spy计划基础设施、委员会和进程的门户，以实现 通过更新将计划项目中出现的产品集成到i-spy 2试验中 协议和监管提交文件。 这一核心的领导层深度整合在I-SPY 2网络的现有结构中。这将是 使计划项目能够高效、无缝地利用大量基础设施和专业知识 I-spy 2网络实现其总体目标。这包括各个工作组的目标是 代理商选择和审查，外部咨询委员会，以及重要的制药伙伴关系发展， 将在访问作为切换代理产品组合一部分的新型代理方面发挥重要作用。的关键作用 核心将是促进通过监管途径取得进展，这两个途径都是为了最初批准虚拟 RCB和治疗切换，但也涉及通过SMART试验确定的代理的批准路径 作为对初始标准新佐剂或靶向反应不足的患者的有效救援剂 化疗。正如i-spy 2的成功所表明的那样，这是一支经验丰富的团队，有能力领导 以及使用经过验证的集成生物标记物组件管理大型、复杂的临床试验 在i-spy 2试验中快速和成功地整合新流程和程序的记录 框架。

SUMMARY-CORE 3 This Program Project comprises four individual projects, which will: implement evidence-based sequential multiple treatment assignment strategies for patients predicted to have insufficient response to their initial neoadjuvant targeted and/or chemotherapy (Project 1); qualify non-invasive imaging metrics for determining markers of non-response (Project 2); characterize the biology of non-responders to inform treatment selection (Project 3); and develop a portfolio of agents and decision tools for treatment re-assignment matched to biology of non-responding tumors (Project 4). The primary aims of the Leadership and Administration Core are to ensure program integration, collaboration and regulatory advancement by providing project management leadership and administrative support to the Projects and Cores in three areas: Aim 1: Provide project management and administrative oversight of all Projects and Cores. Aim 2: Coordinate scientific meetings and regular web and video conferences to facilitate project-wide communication, scientific interactions, and advancements in regulatory science. Aim 3: Act as a gateway to the existing I-SPY Program infrastructure, committees, and processes to enable the integration of products that emerge from the Program Project into the I-SPY 2 TRIAL through updates to the protocol and regulatory submissions. The leadership of this Core is deeply integrated within the existing structure of the I-SPY 2 network. This will enable the Program Project to efficiently and seamlessly leverage the substantial infrastructure and expertise of the I-SPY 2 network in fulfillment of its overall goals. This includes the various working groups targeting agent selection and review, external advisory boards and importantly, pharma partnership development, which will play an important role in accessing novel agents as part of the switching agent portfolio. A critical role of the core will be to facilitate progress through the regulatory pathway, both for the initial approvals for virtual RCB and treatment switching, but also concerning approval pathways for agents identified via the SMART trial as effective rescue agents in patients with insufficient response to initial standard neoadjuvant or targeted chemotherapy. As demonstrated by the success of I-SPY 2, this is an experienced team capable of leading and managing large, complex clinical trials with integrated biomarker components that has a proven track record for rapidly and successfully integrating new processes and procedures within the I-SPY 2 TRIAL framework.