Lung Transplant Consortium - Data Coordinating Center

肺移植联盟 - 数据协调中心

• 批准号: 10427941
• 负责人: Jason D Christie
• 金额: $ 244.43万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-05 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10427941
• 关键词: Address; Biological; Case Report Form; Cells; Clinical; Clinical Data; Clinical Research; Clinical Trials; Cohort Studies; Collaborations; Collection; Communication; Communities; Data; Data Coordinating Center; Data Element; Data Set; Development; Enrollment; Ensure; Faculty; Focus Groups; Funding; Genetic Markers; Home; Individual; Infrastructure; Institutional Review Boards; Internet; Joints; Knowledge; Leadership; Life; Liquid substance; Longterm Follow-up; Lung; Lung Transplantation; Lung diseases; Maintenance; Manuals; Methodology; Monitor; National Heart, Lung, and Blood Institute; Observational Study; Organ Transplantation; Outcome; Outcome Measure; Participant; Patient Outcomes Assessments; Patients; Peer Review; Pennsylvania; Plasma; Postoperative Complications; Postoperative Period; Preparation; Principal Investigator; Procedures; Process; Protocols documentation; Publications; Regulatory Affairs; Reporting; Research; Research Institute; Research Personnel; Resources; Safety; Sampling; Site; Specimen; Structure; Time; Transplant Recipients; Transplant-Related Disorder; Transplantation; Transplantation Surgery; Transplanted Lung Complication; Universities; University resources; Update; base; biobank; candidate selection; care recipients; clinical biomarkers; clinical center; data management; data quality; design; digital health; experience; graft dysfunction; improved; innovation; lung basal segment; lung development; meetings; operation; organizational structure; patient engagement; prevent; prospective; pulmonary function; research study; social media; sound; success; web site

ABSTRACT Lung transplantation is an effective and life-extending treatment for patients with advanced lung diseases. However, improvements are needed in donor management, candidate selection, and recipient care to prevent early postoperative complications and improve the long-term success of lung transplantation. To address these unmet needs, the NHLBI is creating the multisite Lung Transplant Consortium (LTC) to conduct clinical and mechanistic observational research across up to 8 clinical centers (CCs) and up to 24 individual sites. Central to the success of the LTC is a single Data Coordinating Center (DCC) that will oversee consortium wide activities including the development and implementation of a common protocol that will enroll approximately 3200 lung transplant subjects prospectively collecting clinical data and serial biosamples to create a unique resource for future research. With this application, the Duke Clinical Research Institute (DCRI), proposes to serve as the administrative and operational home for the LTC DCC, partnering with the biorepository expertise and resources of the University of Pennsylvania (Penn). The DCRI-Penn DCC brings unparalleled clinical lung transplant subject matter expertise, longstanding prior experience coordinating multicenter research studies in lung transplantation, and operational rigor in research oversight and biosample collection that will fully support and enhance the LTC committee structure, common protocol design and implementation, and CC studies. The DCC will be led by the Multiple Principal Investigator team of Drs. Palmer, Christie, and Neely, who together bring considerable and complementary expertise in clinical and research aspects of lung transplant, data and statistical methodology, leadership experience in the design, coordination, and publication of multicenter research studies in lung transplant and lung diseases. The DCRI-Penn DCC team comprises additional experts in transplant surgery, data management, regulatory affairs, site-based research oversight and monitoring, digital health, patient engagement, web design and communication. Thus, the DCC team is optimally poised to collaboratively partner with the NHLBI and CCs to complete the following Aims: 1) create LTC administrative infrastructure that facilities efficient team communication, timely dissemination of study results and data, and public engagement, including creation and maintenance of the LTC website that serves as a focal point for protected consortium communication and engagement of the broader lung transplant community and key stakeholders 2) provide thought leadership and operational input that ensures the efficient development of high-impact, operationally feasible, and scientifically rigorous common protocol and CC studies, 3) oversee common protocol conduct including use of a single IRB, site operations, robust collection of serial subject data and biosamples, monitoring of data quality, and safety reporting in a manner that results in timely subject enrollment and ensures the rigor, quality, and completeness of clinical data and biosamples.

抽象的 肺移植对于晚期肺病患者来说是一种有效且延长生命的治疗方法。 然而，需要改进捐赠者管理、候选人选择和接受者护理，以防止 术后早期并发症并提高肺移植的长期成功率。为了解决这些 由于未满足需求，NHLBI 正在创建多站点肺移植联盟 (LTC)，以开展临床和 跨多达 8 个临床中心 (CC) 和多达 24 个单独站点的机制观察研究。中央至 LTC 的成功在于一个单一的数据协调中心 (DCC)，该中心将监督联盟范围内的活动 包括制定和实施一项共同方案，该方案将招募约 3200 名肺患者 移植受试者前瞻性地收集临床数据和连续生物样本，以创建独特的资源 未来的研究。通过此申请，杜克临床研究所 (DCRI) 建议充当 LTC DCC 的行政和运营中心，与生物样本库的专业知识和资源合作 宾夕法尼亚大学（Penn）的。 DCRI-Penn DCC 带来了无与伦比的临床肺移植 主题专业知识、协调肺部多中心研究的长期经验 移植，以及研究监督和生物样本收集方面的严格操作，这将充分支持和 加强 LTC 委员会结构、通用协议设计和实施以及 CC 研究。 DCC 将由博士的多重首席研究员团队领导。帕尔默、克里斯蒂和尼利，他们一起带来了 在肺移植的临床和研究、数据和统计方面拥有丰富且互补的专业知识 多中心研究设计、协调和发表的方法论、领导经验 在肺移植和肺部疾病中。 DCRI-Penn DCC 团队由移植领域的其他专家组成 手术、数据管理、监管事务、现场研究监督和监测、数字健康、 患者参与、网页设计和沟通。因此，DCC 团队已做好最佳协作准备 与 NHLBI 和 CC 合作，完成以下目标： 1) 创建 LTC 管理基础设施 促进高效的团队沟通、及时传播研究结果和数据以及公众参与， 包括创建和维护 LTC 网站，该网站作为受保护联盟的联络点 更广泛的肺移植界和主要利益相关者的沟通和参与 2) 提供 思想领导力和运营投入，确保高影响力、可运营的项目的高效发展 可行且科学严谨的通用方案和 CC 研究，3) 监督通用方案的实施 包括使用单一 IRB、现场操作、连续受试者数据和生物样本的可靠收集、监测 数据质量和安全报告，以确保及时受试者登记并确保严谨性， 临床数据和生物样本的质量和完整性。