The Biostatistics and Data Management Core provides services to MPRC investigators in three areas: 1) statistical consulting; 2) database management; and 3) network and computer services. Overall leadership for the Biostatistics Core is provided by Robert McMahon, a Ph.D. biostatistician.
Under the direction of Dr. McMahon, statistical consulting and programming services are provided by three master’s level statistical analysts. Biostatistical consultation services provided to ACISR investigators include:
Review of prospective protocols and advice on validity and efficiency of the study design, sample size, identifying key outcomes and planning an assessment schedule.
Assistance preparation of detailed protocols and grant applications.
Collaboration with data management and clinical research staff to implement protocols and monitor their progress, advise on statistical aspects of design and data collection, and provide randomization services for blinded clinical trials.
Assistance in preparing reports to the MPRC Data and Safety Monitoring Board.
Assistance in data analysis and writing manuscripts.
Biostatistical review of manuscripts originating within the MPRC before submission to journals.
The goal of the Biostatistics Core is to make state of the art statistical methodology available to all ACISR investigators. Current statistical research interests include longitudinal data analyses in clinical trials and analyses of multiple outcome measures, with particular application to neuropsychological outcomes in clinical trials.
Data base development and support is provided by Julie Grim-Haines, M.A., with many routine duties (e.g., querying tables for routine reports and extracting analysis files) being performed by the statistical analysts. Clinical research data at MPRC are maintained in Microsoft Access® databases. Multiple levels of protection (firewall and antivirus security, access control via passwords, replacing identifiers with codes, etc) are used to protect confidentiality of patient records and maintain HIPAA compliance. Customized reports are available to monitor recruitment progress, identify missing records and provide other tools for data and protocol management.
Robert Munson, M.A., and Tony Knight have primary responsibility for network administration and computer support services at MPRC.
Primary statistical consultation and collaborations are undertaken by Robert McMahon, Ph.D. Julie Grim-Haines, M.A., is Assistant Director for Data Management, with primary responsibility for database management system design and implementation and direction of SMH-IRC data management activities. Melissa Spindler serves as primary data entry and quality assurance across the center. Walter Meyer, M.S. (ORP), Amie Elliott, M.A.(SRD), and Fang Liu, M.S.(TRP) serve as data managers and statistical consultants within their various programs. Under the direction of Dr. McMahon and Ms. Grim-Haines, they produce basic and inferential statistical analyses, graphics, and carry out data management operations for their programs. Robert Munson, M.A., Assistant Director for Network and Computer Services, has primary responsibility for network administration and computer services, assisted by Tony Knight, computer technician.