Clinical Research & Study Design Core

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PROJECT SUMMARY/ABSTRACT: Study Design and Clinical Research Core (Clinical Core) The major functions of the Study Design and Clinical Research Core of the Texas Medical Center Digestive Disease Center (DDC) 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, (3) develop disease-specific databases and repositories, and support comprehensive data analyses and interpretation of basic, translation, clinical and epidemiological studies. The Specific Aims of this core are to successfully execute these functions. 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 applications; and educating members via meetings and seminars. Achievements 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. The Clinical Core will continue to support establishment of the organoid biorepository and expand the specimen collection service to collect tissue from preneoplastic lesions. We propose new DDC member-exclusive services that include advanced statistical analytical programs, artificial intelligence and machine learning, and guidance with causal inference modeling. New data management services have been integrated including REDCap, dashboards, and applications that interface with laboratory and clinical aspects of the Core. We also anticipate the growth of demand for expertise related to health services research in digestive diseases from newly recruited investigators and the NIDDK training program in epidemiology and outcomes of GI diseases. The Clinical Core will also expand the specimen collection service to collect specimens for assessing exposure to heavy metal; this new protocol is highly sought after by investigators studying the role of heavy metals exposure in gastrointestinal and hepatic injury and inflammation. Twenty-two DDC members used the Core during the current funding cycle, accruing more than 13,500 hours of service. We supported 24 grant applications (30% already funded) and 200 peer-reviewed publications.