The mission of the Data Coordinating Center (DCC) is to support investigator-initiated NIH or industry-sponsored randomized controlled trials (RCTs) by providing expertise in statistical methodology and support for data management, quality control and assurance, study monitoring and communications using clinical trials data management system and other information systems.
The Data Coordinating Center (DCC) is a component of the Clinical Trials Program in the Department of Biostatistics and Medical Informatics (BMI) in the UW School of Medicine and Public Health. The DCC supports and is engaged in collaborative clinical research projects which are NIH- or industry-funded data coordinating centers. DCCs play a critical role in coordinating and implementing large multi-center randomized controlled trials (RCTs) and other types of clinical research studies, bringing expertise in planning, conduct, monitoring, analysis and reporting and in data management, quality control and quality assurance, and information technology support for trial monitoring and communication, all needed to complement the clinical investigators’ content expertise.
The DCC collaborates in protocol development and takes responsibility for statistical design and data analysis. The DCC provides case report forms (CRFs) and data management; statistical analysis; collaborates in manuscript preparation; and provides study training, coordination and quality assurances, including coordination of the activities of the data and safety monitoring board (DSMB), the protocol review committee (PRC), the executive and steering committees, and other standing committees. Additional activities may include support of ancillary study activities; support for study drug distribution; and development and maintenance of websites or online resources for the studies.
DEPARTMENT OF BIOSTATISTICS AND MEDICAL INFORMATICS
Within the UW School of Medicine and Public Health, the Department of Biostatistics and Medical Informatics provides a vital environment for research, collaboration, and training in biostatistics and informatics, and is the home for the interdisciplinary biostatistics training program. There are now 23 PhD-level statisticians and computer scientists with faculty appointments (full or partial) in the Department, five having joint appointments in the Statistics Department and seven having joint appointments in other departments such as Computer Science and Population Health Sciences. In addition, there are 13-affiliate faculty. These strong faculty-level connections support a high level of interdisciplinary research and enable the coordination of graduate student training. What is now the Department of Biostatistics and Medical Informatics originated in 1984 as the Biostatistics Center and became formally approved by the University in 1986 as the focus for statistical research and collaboration between the Department of Statistics and the Medical School. Its development really began in 1982 with the recruitment of Dr. David DeMets from the NIH to develop a Cancer Biostatistics Program for the UW Clinical Cancer Center. The Biostatistics Center gained departmental status in 1992. In 1996 the name was changed to Biostatistics and Medical Informatics to reflect the growth and development in the rapidly evolving field of bioinformatics and information technology with research activities focused on bioinformatics, computational molecular biology, clinical informatics and medical imaging. The Department of Biostatistics and Medical Informatics is organized into three major research and training programs: Biostatistics, Clinical Trials and Medical Informatics, including a training grant from NHLBI. The Department of Biostatistics and Medical Informatics currently employs over 100 individuals, including 13 PhD-level scientists, MS-level biostatisticians, programmers, and support staff.
The BMI faculty have very active research programs, receiving more than $3,000,000 direct costs as principal investigators on research projects from NIH and NSF last fiscal year. These grants are in areas that include biostatistics applied to pre-clinical, clinical and population health research; biomedical and clinical informatics; and statistical genetics and genomics. In addition to methodological research, the faculty in the Department of Biostatistics and Medical Informatics collaborate with clinical and laboratory investigators on campus, nationally and internationally. These collaborations often motivate biostatistics and bioinformatics research on new methods to answer scientific questions, further enhancing collaboration and scientific interaction.
Most faculty members in the department are located in 5,054 square feet in the WARF Building that houses the Biostatistics and Clinical Trials Programs as well as the Biostatistical Computing Group. The Department has 5,321 square feet in the Medical Sciences Center building for the Medical Informatics Program, and 4,000 additional square feet in the Biotechnology Center for statistical genetics and genomics.
Clinical Trials Program
The Clinical Trials Program is one of three programs in BMI. The mission of the Clinical Trials Program is as follows: 1) to train the next generation of clinical biostatisticians with advanced training in clinical trials methodology and data coordinating activities and exposure to randomized controlled trials (RCTs) sponsored by the National Institutes of Health and the biopharmaceutical and device industry, 2) to serve as an incubator for methodological advances in RCTs, 3) to provide expertise in clinical biostatistics and data coordinating center activities in support of UW investigator-initiated RCTs, and 4) to provide data monitoring committee support services to industry-sponsored phase III multisite national and international RCTs. The Clinical Trials Program (CTP) serves as a focal point for faculty with expertise and interest in clinical trial methodology and draws upon a range of collaborative experiences to identify the challenging problems in RCTs. It provides a home for Biostatistics graduate students interested in a research practicum or other training.
Data Coordinating Center
The Data Coordinating Center (DCC) is a component of the Clinical Trials Program and serves as NIH-funded data coordinating centers for a number of projects. The DCC plays a critical role in coordinating and implementing multi-site (RCTs and other types of clinical research studies, bringing expertise in statistical methods for planning, conduct, monitoring, analysis and reporting and expertise and resources in clinical research informatics and information technology to support data management.
Over the past twenty years, BMI has developed a centralized state-of-the-art computing facility for the support of statistical and medical informatics research, and for the management and analysis of clinical, genomic and other biological data. The computational resources include a network of 120 multi-core, 64-bit Linux servers (totaling more than 2,900 cores). A growing number of compute servers additionally have GPUs for high-performance computation.
The facility currently houses 540 terabytes of enterprise-grade, networked storage configured in a redundant, multi-homed setup. Most of these machines are made available for compute-bound tasks by a locally developed software system called HTCondor. HTCondor automatically locates workstations that are idle and transfers jobs to them. The jobs are periodically check pointed and migrate from machine to machine, as needed, until completion. Additionally, access to the campus Condor High Throughput Computing facility can also be granted to specialized jobs. The HTCondor system provides excellent support for the extensive experimentation that is typical of machine-learning research; completes about 5.5 million CPU hours of work per year. A full complement of up-to-date computational tools are available, including R, SAS and Matlab for statistical exploration, Python for machine learning, as well as a number of optimizing compilers and a large suite of utilities. LaTeX and Word are fully supported for producing publication-quality papers.
The environment of the central computing facility is fully temperature-controlled and power conditioned and uses the Hospital’s emergency power system. On a 24/7 basis, temperature, server functionality and security are also monitored by automated systems that notify an on-call staff member if problems arise. Remote access generally makes remote repairs possible during off-hours. All BCG-supported computers are connected to the Medical School’s network and are behind its firewall. Highly experienced, full-time staff in the Department of Biostatistics and Medical Informatics provide such services as network access, file backup and recovery, software installation and support, maintenance of shared printers, etc.
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• Provides case report forms (CRFs)
• Data management
• Collaborates in manuscript preparation
• Coordination and quality assurances
• Coordination of the activities of the data and safety monitoring board (DSMB), the protocol review committee (PRC), the executive and steering committees, and other standing committees.
• Support of ancillary study activities
• Support for study drug distribution
• Development and maintenance of websites or online resources for the studies.
• Provides the statistical expertise in randomization
• Preparation of statistical analysis plans for interim and final analyses
• Monitoring of trial conduct
• Interim analysis for review of safety and efficacy by the DSMB
• Final analysis and production of the final report
• Interpretation of findings from analysis
• Preparation of results for presentation and publication of findings from the trial
• Development of new/novel statistical methods for analysis of complex time to/recurrent events
• Report findings to the DSMB