Clinical Component

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Clinical Component - Abstract The goal of the Medical University of South Carolina (MUSC) Digestive Disease Research Core Center (DDRCC) Clinical Component (CC) is to establish a research support infrastructure of biostatisticians and research operations to promote the effectiveness of research performed by Center members. This will be accomplished by supporting the design, implementation and analysis of research studies in digestive and liver diseases that fall thematically into the DDRCC’s major research priorities. The CC has several unique features, including an extensive track record of prominent, collaborative research in digestive and liver diseases, led by Dr. Valerie Durkalski, Professor of Biostatistics and Director of the Data Coordination Unit (DCU) in the Department of Public Health Sciences at MUSC. Dr. Durkalski and her team are ideally positioned to fill this role based on their experience as the statistical and data coordinating center for many NIH-funded multicenter clinical trials and research studies. Further, CC team members are already heavily involved with Center investigators on a number of NIDDK-funded multicenter studies in gastrointestinal disease. The CC has two Specific Aims: In Aim 1, the CC will collaborate with DDRCC Biomedical Research Cores and DDRCC members to support basic, translational and clinical digestive and liver disease research, and to facilitate the translation of basic research into the clinical setting. The CC members will utilize their expertise in the design and coordination of digestive disease basic, translational and clinical research studies to collaborate with DDRCC members in the planning and execution of proposed research projects. In Aim 2, the CC will provide statistical expertise and support for DDRCC members. The CC will apply their statistical expertise to contribute to the design of innovative and efficient research studies (basic research studies, clinical trials, translational and observational studies), analysis and presentation of pilot data, and the development of grant submissions that will address proposed research questions. The CC will also foster the professional development of New Investigators. In summary, the CC is ideally poised to provide a cohesive platform for facilitating the proposed aims and is well-prepared and committed to ensuring a successful and productive collaboration with the DDRCC Research Cores and members.