Expertise
The investigators and staff of the CCCT have the personal and technical expertise to design, organize, and successfully execute large-scale multicenter randomized controlled clinical trials. The CCCT has special expertise in hypertension, lipid-lowering, and retinopathy of prematurity, and additional expertise in quality of life and cost-effectiveness. Our approach is to combine statistical, clinical trials, medical, data management, and fiscal/administrative expertise and experience from seasoned investigators and staff to provide leadership and collaboration for the operation of a first-class coordinating center.
Operating a Coordinating Center
Specific competence and prior experience of professional, technical, and administrative staff pertinent to the operation of a coordinating center in large multicenter randomized clinical trials related to cardiovascular disease (particularly involving drug therapy) with clinical outcomes. The versatility of the organizational and administrative structure of the CCCT has been tested over time. The CCCT has successfully participated in large, long-term cardiovascular multicenter randomized trials, both in central data management and coordination of protocol-mandated study activities.
Determining Medical and Scientific Expertise
Ability to determine the suitability of on-site medical and scientific expertise in cardiovascular medicine and therapy and management of side effects and adverse reactions. Suitability of on-site or consultant expertise in analysis and interpretation of special or ancillary investigations such as cost-effectiveness and quality of life.
Publishing Study Findings
Ability to take appropriate leadership in preparation of scientific reports and manuscripts and publication and presentation of study findings and results.
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Managing Trials
Skilled in the methods used to coordinate and manage a complex randomized clinical trial consisting of multiple clinics and or networks, core laboratories, reading centers, and drug distribution centers. These methods include those related to organizing and monitoring recruitment and follow-up of study patients from multiple clinical sites and networks.
Overseeing Protocols
Ability to oversee implementation of a study protocol in a standardized fashion in both clinical networks and central units, to provide expert guidance and authoritative direction and timely problem solving, and to communicate effectively. Ability to finalize a study protocol and manual of operations, including forms development, and to conduct central training.
Managing Data
Highly skilled in designing and developing web-based applications for data collection and randomization, and in executing plans for central data acquisition, management, and analysis, including randomization of patients and quality control measures.
Contracting Core Center Operations
Contract and oversee central processing and interpretation of blood chemistry, ECG, diet, health care cost, quality of life, and other special core center operations.
Understanding Scientific Issues
In depth knowledge and understanding of scientific issues related to the trial rationale and design, including the importance of the research question, knowledge of cardiovascular disease, and understanding of trial design and state-of-the-art analysis methods.
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