Project-004

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The lack of sufficient high-quality, reproducible data across clinical and translational research is creating a major obstacle for the effective translation of basic research to improve health outcomes. This complex problem includes inadequate study design, inefficient dissemination of research findings, inadequate patient recruitment, suboptimal use of electronic health practices, and poor documentation practices. About two thirds of typical errors are related to problems in the experimental design and performance. Proper study design involves a comprehensive approach to planning, performance, documentation, analysis, and publication. The research methods experts at UTMB play a critical role in comprehensive study design and statistical analysis, as well as interpretation and dissemination of high-quality, ethical clinical and translational research. We have experience across the entire translational research continuum, with particular expertise in bioinformatics, patient-centered outcomes research/comparative effectiveness research, large database analysis, clinical trials, data mining, and network analysis. In this research methods component we will address the major issues in clinical and translational studies making our CTSA more effective, efficient, and making our studies easily disseminated to improve health across the country. To accomplish this, we will provide resources to our investigators in the areas Biostatistics, Epidemiology and Research Design. The Biostatistics Epidemiology and Research Design group will provide researchers easy access to biostatistical education/training, research design consultation, and innovative tools and methods to enhance the quality, rigor and efficiency of clinical and translational. The Office of Clinical Research will provide investigators and study teams with focused regulatory knowledge and clinical trial management support. We will support investigators with innovative tools such as developing apps to assess data quality and data mining methods to assess pharmacotherapy-associated toxicities. We will also apply innovative techniques to enhance trial design and to analyze the results of comparative effectiveness research. In addition, we will develop a process to obtain electronic consent.Our Research Methods component will enhance innovation, access and quality of clinical and translational research at UTMB. This is accomplished with tight integration between research methods, hub capacity, and informatics. Our research methods program encompasses two integrated modules. The Biostatistics, Epidemiology and Research Design (BERD) team is an essential component of the translational research mission at UTMB, providing: team-based collaboration and consultation on research design and biostatistics; continuous education, mentoring and training to students and faculty; and strong support to the informatics core. BERD will continue to play a critical role in developing innovative research methods at UTMB, with particular emphasis on enhanced clinical trials, advanced comparative effectiveness research methods, and novel data management tools. The Office of Clinical Research (OCR) was established in June 2011 as a joint initiative between Research Services and the CTSA. It is a multidisciplinary service organization, staffed by a team experienced in sponsored clinical research, that supports faculty with sponsored clinical trials and investigator-initiated clinical research projects. Guided by the continuous improvement model of our Innovation Score Card, the integrated modules of our Research Methods component will address the following Specific Aims: