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.

摘要 肺移植是治疗晚期肺部疾病的一种有效且延长生命的方法。 然而，在捐赠者管理、候选人选择和受赠者护理方面需要改进，以防止 术后早期并发症及提高肺移植远期成功率。要解决这些问题 未得到满足的需求，NHLBI正在创建多站点肺移植联盟(LTC)，以进行临床和 覆盖多达8个临床中心(CCS)和多达24个独立站点的机械性观察性研究。中心到 LTC的成功是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通用方案，该方案将招收约3200个肺 移植受试者前瞻性地收集临床数据和系列生物样本，以创建独特的资源 未来的研究。通过这一应用，杜克临床研究所(DCRI)建议作为 LTC DCC的管理和运营之家，与生物库专业知识和资源合作 宾夕法尼亚大学(宾夕法尼亚大学)。DCRI-Penn DCC带来了无与伦比的临床肺移植 学科专业知识，协调肺部多中心研究的长期经验 移植，以及在研究监督和生物样本收集方面的操作严格性，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Palmer，Christie和Neely博士组成的多位首席调查员团队领导，他们共同带来了 在肺移植的临床和研究方面、数据和统计方面有相当多和互补的专业知识 设计、协调和发表多中心研究报告的方法、领导经验 在肺移植和肺部疾病方面。DCRI-Penn DCC团队包括更多的移植专家 外科手术、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团队已做好协作的最佳准备 与NHLBI和CCS合作完成以下目标：1)创建LTC管理基础设施， 设施高效的团队沟通，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，作为受保护财团的协调中心 更广泛的肺移植社区和主要利益攸关方的沟通和参与2)提供 思想领导力和运营投入，确保高效开发高影响力的运营 可行且科学严谨的共同协议和CC研究，3)监督共同协议行为 包括使用单一IRB、现场操作、连续主题数据和生物样本的可靠收集、监测 数据质量和安全报告，以导致及时的科目登记并确保严格性， 临床数据和生物样本的质量和完整性。