Participant Engagement Unit

项目摘要--参与者参与股(PEU) PU将负责让患者进入华盛顿大学的直接参与者参与 (五)PE-CGS计划。在PIS Fields和Drake的指导下，我们将利用调查员和 直接应对癌症登月蓝丝带小组建议的机构专业知识 一个直接与病人接触的网络“。我们将对直接与PEU特定的8个领域进行优先排序 目标：(1)识别；(2)接触；(3)同意参与者；(4)获取肿瘤/正常样本和临床/转移 数据；(5)创建和预期维护患者、样本和正在进行的治疗数据；(6)报告研究 使用尖端、创新、信息学驱动的方法直接向研究参与者提供研究结果 利用独特的合作伙伴关系；(7)引导患者通过WU-PE-CGS计划的“流动”，提供 监督整个方案的整合；以及(8)与其他WU-PE-CGS“单位”双向互动，以便 基于对参与者的前瞻性研究，对计划范围内的协议进行持续、迭代的改进。 为了在这七个与癌症登月任务相一致的领域取得成功，我们需要新的 参与的范例。WU-PE-CGS在我们的 总体任务是“开发、实施、评估和修改”。首先，我们已经与三家世界级的 在直接与患者合作伙伴(PP)合作方面拥有丰富经验的患者权益倡导团体(PAG) 在推进癌症护理方面：胆管癌基金会(CCF)、抗击结直肠癌(FCRC)和 多发性骨髓瘤研究基金会(MMRF)。第二，我们将利用我们的制度优势 直接解决本RFA在基因特征和与患者接触方面的所述知识空白 研究不足的肿瘤类型(胆管细胞癌[CHOL])和少数人研究不足的癌症 人口(50岁以下非裔美国人的结直肠癌[CRC-AA&lt；50]和#年多发性骨髓瘤 非洲裔美国人[MM-AA])第三，我们将采用双向、实时、信息化驱动的方法来 与EOU互动，评估并反复改进我们的计划，以确保WU-PE-CGS以最佳方式 识别、登记、评估参与者并与其互动。 PEU的创新和有影响力的目标直接解决了癌症登月计划的目标：直接征募 患者参与度…促进参与研究，确保患者得到尊重和接触 向“具有高度优先地位”的研究企业“接触少数群体和未得到充分服务的人群”。我们的合作伙伴关系 通过PAG和PPS，利用调查人员和机构的专业知识，遵守PCORI Rubrics，以及 正在进行的方法改进将导致对广泛的癌症类型进行有影响力的研究。

PROJECT SUMMARY – PARTICIPANT ENGAGEMENT UNIT (PEU) The PEU will be responsible for direct participant engagement to enroll patients into the Washington University (WU) PE-CGS program. Under the direction of PIs Fields and Drake, we will leverage investigator and institutional expertise to directly address the Cancer Moonshot Blue Ribbon Panel recommendation to “establish a network for direct patient engagement”. We will prioritize 8 areas that are directly tied to the PEU Specific Aims: (1) identify; (2) contact; and (3) consent participants; (4) obtain tumor/normal samples and clinical/meta data; (5) create and prospectively maintain patient, specimen, and ongoing treatment data; (6) report research findings directly to study participants using cutting-edge, innovative, informatics-driven methodologies that leverage unique partnerships; (7) guide patients through the “flow” of the WU-PE-CGS program, providing oversight of program-wide integration; and (8) bi-directionally interact with the other WU-PE-CGS “Units” for ongoing, iterative refinement of program-wide protocols based on prospective study of participants. To achieve success in these seven areas that is in-line with the Cancer Moonshot mission, we need novel paradigms for engagement. The WU-PE-CGS has developed several innovative approaches following our overall mission to “develop, implement, evaluate, and modify”. First, we have partnered with three world-class patient advocacy groups (PAGs) that have significant experience in working directly with patient-partners (PPs) in advancing cancer care: The Cholangiocarcinoma Foundation (CCF), Fight Colorectal Cancer (FCRC), and The Multiple Myeloma Research Foundation (MMRF). Second, we will leverage our institutional strengths to directly address this RFA's stated knowledge gaps of genomically characterizing and engaging patients with understudied tumor types (cholangiocarcinoma [CHOL]) and cancers that are understudied in minority populations (colorectal cancer in African Americans under the age of 50 [CRC-AA<50] and multiple myeloma in African Americans [MM-AA]). Third, we will employ bi-directional, real-time, informatics-driven methods to interact with the EOU to evaluate and iteratively refine our program to ensure that the WU-PE-CGS optimally identifies, enrolls, evaluates, and interacts with the participants. The innovative and impactful aims of the PEU directly address the Cancer Moonshot goals of “enlisting direct patient engagement…to facilitate participation in research and ensure patients are respected and have access to the research enterprise” with a high priority “to reach minority and underserved populations”. Our partnerships with PAGs and PPs, leveraging of investigator and institutional expertise, adherence to PCORI rubrics, and ongoing methodological refinement will result in impactful research across a broad group of cancer types.