The Biostatistics and Data Management Core for the University of Texas M. D. Anderson Cancer Center Oral Cancer P01 will be a comprehensive, multi-lateral resource for data acquisition and management, designing clinical and basic science experiments, developing innovative statistical methodology, statistical analysis, and publishing translational research generated by the program project. The Biostatistics and Data Management Core will incorporate sound experimental design principles within each project that will increase the clarity and enhance interpretability of study results. Each project will be provided with tailored analyses, accompanied by novel statistical development as necessary, to reveal apparent and hidden relationships among data. The Biostatistics and Data Management Core will provide expertise in the design of an integrated data management system to facilitate communication among all projects and cores. This process includes prospective data collection, data quality control, data security, and assurance of patient confidentiality. The Biostatistics and Data Management Core will collaborate with all project investigators to facilitate the timely publication of all data collected under the P01 research program. The main objectives of the Biostatistics and Data Management Core are: 1. To provide the statistical design, sample size and power calculations for each project. 2. To facilitate prospective collection, entry, quality control, and integration of data for the basic science, pre-clinical, clinical, and epidemiological studies associated with the Oral Cancer P01. 3. To provide study monitoring and conduct that ensures patient safety by timely reporting of toxicity and interim analysis results to various IRBs, the Data Monitoring Committee, the NCI, and other regulatory agencies. 4. To develop a secure, international, internet-driven database network between the Norwegian Radium Hospital and UTMDACC that integrates the clinical data generated by the clinical research program and subsequent epidemiological and basic science research efforts of the program project. 5. To develop a comprehensive web-based database management system for tracking, distribution, and central repository of all Oral Cancer P01 biomarker data. 6. To provide all statistical data analysis including descriptive statistical analysis, hypothesis testing, estimation, and modeling of prospectively generated data. 7. To develop & adapt innovative statistical methods pertinent to biomarker-integrated translational oral cancer studies. 8. To generate statistical reports for all projects and to collaborate and assist all project investigators in the publication of scientific results.
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