The major functions of the Study Design and Clinical Research Core are to (1) serve clinical and basic science investigators in digestive diseases with comprehensive study design consultation and support, (2) assist DDC investigators in all aspects of the acquisition of clinical specimens required for their research in digestive diseases, and (3) support comprehensive data analyses and interpretation of basic, translation, clinical and epidemiological studies. The Core has been highly productive and beneficial for members of the TMC DDC. In the last 4 years, 29 members used the study design consultation and support services, 49 DDC members used the statistical component of the Core, and 13 members obtained help with specimen acquisition and handling. This Core is primarily a DDC Core; 75% of Core users in the last 2 years were either full or associate members of the DDC. Over 50 members anticipate using this Core in the next project period. Major Core services include providing study-design and statistical-analysis support; establishing procedures for data management and database organization to facilitate efficient analyses; assisting DDC investigators in acquiring clinical specimens needed for their research; assisting and training in compliance, patient confidentiality and oversight issues, including preparation of IRB requests and preparation of Investigational New Drug (IND) applications; and training. The Clinical Core fulfills an important need for the DDC investigators at Baylor College of Medicine (BCM), where there is no department of epidemiology or biostatistics or a funded Clinical Translational Science Award grant. For the new funding period, Core E will continue to support ongoing and innovative research to prevent and cure digestive diseases. We also propose new DDC member-exclusive services that include cutting edge statistical analyses, enhanced research coordination service, and establishment of a enteroid biorepository. Both Core Co-Directors brings a unique area of expertise in clinical, translational, and epidemiological research, namely sample and tissue collection, epidemiology and health services research, and biostatistics. Advances during the current funding period include the expansion of sample and tissue collection and banking, and the increased number of requests involving epidemiology and health outcomes research, especially those using electronic databases to capture large amounts of patient information, risk factors, therapies, and outcomes; these databases include large disease registries and healthcare claims data. During the current award cycle, the has been critically involved in developing the new service in the newly reorganized GEMS Core of the DDC, providing human organoids to DDC investigators. The Core will continue to support establishment of the enteroid biorepository and expand the specimen collection service to collect tissue from livers. This service is highly sought after and will be shared with researchers studying gastrointestinal injury and inflammation.
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