The Cardiovascular Cell Therapy Research Network (CCTRN) will be organized to conduct phase I and II collaborative trials of emerging cell based treatments of cardiovascular disease. A Steering Committee of participating Investigators will select several (~4) protocols from among those proposed by the selected Clinical Centers. These studies will be organized, managed and administered by a Data Coordinating Center (DCC) which will select and oversee a core cell processing center, chemistry labs or imaging centers as necessary for the selected studies. All trials will be monitored by a CCTRN Data and Safety Monitoring Board as well as regulatory agencies such as the FDA which has oversight authority over INDs. The CCTRN DCC will be located within the Coordinating Center for Clinical Trials (CCCT) at The University of Texas School of Public Health in the Texas Medical Center in Houston. The persons named in this proposal have considerable expertise in biostatististics, coordinating phase II and phase III clincial trials, epidemiology, cell processing, cell therapy, FDA procedures, genetics, data management and analysis, and administration. In cooperation with the NHLBI and CCTRN investigators, the DCC will provide statistical, epidemiological, medical, and scientific leadership in 1) planning and developing the study design, organization and operations 2) developing and implementing research protocols, detailed Manuals of Operations, appropriate randomization schemes (if needed) and suitable analytical and statistical methodology for each investigation, 3) appropriate data acquisition procedures and forms, 4) procedures for study event identification, abstraction, and review, and 5) operations for quality control and training. A comprehensive public web site is proposed for dissemination and communication with the professional and lay communities and study participants. A secure web site will facilitate communications and coordination among participating investigators, staff, and institutions, and will include a web-based data entry and management system that provides on-going monitoring of study progress. The success of each multicenter phase l/lltrial will depend heavily on the close working relationships and effective collaboration among the Data Coordinating Center, Clinical Centers, Project Office, and core labs. For over 30 years, the CCCT investigators and staff have consistently demonstrated the ability to promote and sustain effective collaboration in a series of important, highly successful, multicenter trials and cooperative studies.
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