Network for Cardiothoracic Surgical Investigations in Cardiovascular Medicine(U01

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DESCRIPTION (provided by applicant): The scientific foundations of medicine are broadening at an unprecedented pace and therapeutic interventions, particularly in the area of cardiothoracic (CT) surgery, are burgeoning. As recognized by the NHLBI, the CT surgery field lacks a multi-center, academic infrastructure for proof-of-concept trials of novel surgical and minimally invasive procedures, which the proposed Cardiothoracic Surgery Investigations Network intends to address. Given our long-standing interest and experience in the design and conduct of cardiac surgery trials, the International Center for Health Outcomes and Innovation Research enthusiastically welcomes the opportunity to collaborate with NIH, and the Network Investigators to serve as the Data Coordinating Center (DCC) for the Network. In particular, we will offer the following services to the Network: Trial Design and Protocol Development - The DCC will offer support and leadership in the design of innovative Phase ll-type clinical trials, employing optimal multi-stage designs, procedures for treatment selection in multi-arm studies, selection of surrogate endpoints, construction of composite endpoints, and implementation of novel Bayesian approaches. It will develop protocols, case report forms (CRFs) and operations manuals. Clinical Coordination - The DCC will be in regular contact with Network investigators to help review patient enrollment, discuss recruitment strategies, assist the investigators in drafting management guidelines, and help review the management of Network patients. Data Management - The DCC will provide a secure, validated, centralized electronic data management facility that is HIPAA and FDA-compliant. The DCC will develop and maintain systems to enable direct data entry via the Web, and it will provide automated patient randomization, time stamping, file archiving, data validation and reporting services, and a help desk for technical support. Site Management, Quality Assurance, and Monitoring - The DCC will train clinical investigators in the specifics of the protocol, review the quality of the data, issue queries, monitor the sites on a regular basis to ensure data integrity, and assist the Morbidity and Mortality (M&M) Committee in adjudicating the data. Statistical and Analytical Support - The DCC will generate randomized treatment assignments, perform interim analyses for the Data Safety and Monitoring Board (DSMB), perform final analyses for all Network trials, and participate in the preparation of study presentations and manuscripts. Administrative Support for the Network - The DCC will support all components of the Network, the Protocol Review Committee, the Steering Committee, the Core labs, and the DSMB. The DCC will be responsible for reimbursement for patient accrual, and organize all Network meetings. (End of Abstract)