BIOSTATISTICS AND DATA MANAGEMENT CORE

Univ Of North Carolina Chapel Hill, Chapel Hill NC

Investigators

Linked publications, trials & patents

Abstract

The Digestive Disease Research Core Center at UNC has had a biostatistical core since the center was established in 1985. The name, the directors, and the mission ofthe core have changed over time in response to evolution in the needs and research interests of members. The Biostatistics and Data Management Core has been extensively used by basic science, epidemiology, clinical outcomes and clinical investigators who are CGIBD members and associate members. Furthermore, the Biostatistics and Data Management Core provides a unique national resource to Digestive Disease investigators outside our Center. The Biostatistics and Data Management Core provides state-of-the-art data services and consultation. As described in detaU in the sections that follow, the core assists with the collection, analysis and integration of biological and epidemiological data using techniques of computer science and statistics. We provide assistance vnth database maintenance, web applications, data capture, quality control, data analysis, and statistics. The Core provides an interface between basic scientists and informatics specialists to support translational research. Importantly, the core provides essential services to the large group of clinical epidemiologists who are members of our center. The core is fully equipped and staffed with a suite of offices in the recently opened Bioinformatics Building. For the past decade the CGIBD Biostatistics and Data Management Core has served as the Data Management Center for the Crohn's and Colitis Foundation of America (CCFA) Clinical Alliance. The purpose ofthe Alliance is to conduct multi-center randomized trials of IBD therapy. As the Data Management Center it is our responsibUity to assist in study design and protocol development. We create the case report forms, data entry routines, quality control measures, and analysis plans. Our biostatistician performs all data analyses. The Data Management Center is an excellent example of cooperation between a research university, a private foundation, and an NIH Digestive Disease Research Core Center. We were able to secure the contract v^th the CCFA because ofthe expertise and infrastructure that we developed through our Digestive Disease Research Core Center. In turn, our center members have benefited by the expertise and extra capacity that we have developed through CCFA funding. CGIBD members and associates derive the benefit of a fuU time biostatistician and data management team at their disposal. They also benefit from the equipment, tools and techniques that we have assembled. However, the CGIBD pays for only a small portion ofthe costs associated with the operation ofthe Data Management Center. The bulk ofthe costs are paid for by large research grants and contracts.