Lung Transplant Consortium - Data Coordinating Center

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.