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Division of Clinical Trials

As the statistical methodology for designing, conducting, and analyzing clinical trials has become increasingly sophisticated, the requirements for conducting clinical trials have become more rigorous. In response to increased regulation of statistical and data management expertise as well as the marked rise in the number of large multi-center, multi-national trials, the Department of Biostatistics created data coordinating centers under the Division of Clinical Trials to offer expertise in the storage, management, and analysis of clinical trial and other public health and biomedical data.

The Department's data coordinating centers have kept pace with parallel development of internet-based procedures and more sophisticated web-based data management applications, allowing for fast and secure data transfer and reporting. The centers focus on a number of areas including cardiology, stroke, traumatic brain injury, neurological diseases, cancer, and HIV/AIDS.

The Data Coordinating Center
Center Director: Howard Andrews, PhD, associate clinical professor of Biostatistics and Neuroscience (in Psychiatry)

Jointly housed in the New York Psychiatric Institute, the Data Coordinating Center (DCC) provides data management and project management support for clinical trials and longitudinal epidemiological studies in psychiatry, geriatrics, child environmental health, and other health sciences. DCC's staff also has extensive experience in the processing and analysis of secondary data sources, including vital statistics and other large public data sets.

COBRIT Data Coordinating Center (PDF)
Center Director: William Friedewald, MD, clinical professor of Biostatistics and Epidemiology

The Citicoline Brain Injury Trial (COBRIT) is a nationwide research study funded by the National Institutes of Health. It is designed to learn whether a substance naturally produced b y the body, citicoline, will help patients make a better recovery after traumatic brain injury. Each year, 1.4 million people sustain a traumatic brain injury in the United States, of which 50,000 people die and 200,000 are hospitalized. Despite numerous prior clinical trials no standard treatment has been established. Citicoline offers the potential of employing neuroprotection, neuro-recovery and neurofacilitation to enhance recovery.

The Statistical Analysis Center for Clinical Trials
Center
Director: John L.P. (Seamus) Thompson, PhD, professor of clinical Biostatistics and Neurology

Founded in 2000, the Statistical Analysis Center (SAC) is committed to improving the scientific quality and efficiency of randomized clinical trials through close collaboration with eminent clinical investigators; the application of innovative statistical designs; and the development of state-of-the-art, customized data management systems that are responsive to the needs of clinical and statistical investigators. SAC’s staff have a wealth of experience in clinical trials. The team is experienced in statistical design and analysis, the development of advanced web-based electronic data capture systems, protocol design and implementation, and high quality data management.

Biostatistics Center for Clinical Trials Management
Center Director: Emilia Bagiella, PhD, associate professor of clinical Biostatistics

The Biostatistics Center for Clinical Trials Management (BCCTM) was launched in 2007 and is dedicated to innovative statistical design and the analysis and management of data for clinical trials taking place around the Columbia University Medical Center and at sites around the University, country, and world. The Department created this center in response to the overwhelming demand for specialized statisticians to help investigators create data management programs and to run the analysis and management side of trials. Since its inception a year ago, the Center already manages six federally-funded, multi-center clinical trials in the areas of neurology, pulmonary medicine, and diabetes.

Division of Statistical Genetics
Director:  David Greenberg, PhD, professor of Biostatistics

The Division of Statistical Genetics provides assistance in all phases of genetic studies, including the design, storage, and analysis of data, particularly for studies of common diseases such as epilepsy and schizophrenia. Faculty are leaders in statistical methods of population genetics, linkage and association studies, and computational genomics. Faculty have developed a software/hardware facility to store and analyze genetic data using current analysis techniques that simplify the testing of genetic hypotheses. The Program also develops specialized analysis techniques for individual clinical, medical, and epidemiological studies as needed.