About the Center
Since its inception in 1971 by members of the Biometry (now Biostatistics) faculty of The University of Texas School of Public Health, the Coordinating Center for Clinical Trials (CCCT) has played a leading role in cardiovascular disease and vision research by serving as a coordinating center for 16 nationwide multicenter clinical trials. These large cardiovascular and pediatric ophthalmology studies have been funded with grants and contracts totaling over $173 million. The CCCT's primary function is to provide and coordinate all operations, procedures, and activities of a large-scale randomized controlled clinical trial. These include:
- study design, development, and implementation and enforcement of the study protocol and manual of operations
- project management, data and safety monitoring, and quality assurance
- statistical analysis and interpretation and dissemination of results.
To accomplish its objectives, the CCCT has an experienced staff of 25 individuals with expertise in every aspect of trial design and conduct. They are from the fields of medicine, cardiology, hypertension, genetics, epidemiology, biostatistics, clinical trials methodology, analytical methodology, data management and analysis, and administration. They are adept at:
- operating a coordinating center
- determining medical and scientific expertise
- publishing study findings
- managing trials
- overseeing protocols
- managing data
- contracting core center operations
- monitoring adverse effects
- understanding scientific issues.
The clinical trial centers that the CCCT sets up for each study provide comprehensive services that include:
- developing protocols, forms, and manuals of operations
- designing web-based randomization
- implementing trial management and data gathering systems
- providing training
- selecting sites
- monitoring recruitment and providing recruitment resources
- conducting reviews and evaluations
- monitoring adverse effects and events
- maintaining data bases and analyzing data
- assuring quality control
- establishing core laboratories
- recruiting investigators and centers
- coordinating Steering Committees and Data Safety and Monitoring Boards
- providing annual and interim reports
- collecting final data and producing final data sets and final reports
- overseeing regulatory compliance
- monitoring vital status
- disseminating study information
- altering study methodology as required.
A computing center with OpenVMS, Unix, and Windows 2000 servers and sophisticated data analysis and web development tools contribute to the CCCT's resources.
The CCCT is well integrated into the School of Public Health, has the support and commitment of the Dean and administration, and has been a part of The University of Texas Health Science Center at Houston in the world-renowned Texas Medical Center for more than 25 years. The Coordinating Center for Clinical Trials has had great success throughout its history of collaborating with both federal and corporate sponsors and has a well-established reputation in the field of clinical trial research. Its receipt of the Lasker Award for the Hypertension Detection and Follow-up Program (HDFP) highlights this success.
