Study Design and Clinical Research Core

The Study Design & Clinical Research Core promotes the use of appropriate study design, statistical analyses, and interpretation for clinical and basic science investigators; assists these investigators in acquiring clinical specimens to facilitate their research; and assists investigators in designing and performing translational research. The primary two functions are to provide epidemiological and biostatistical support for design and analysis, and to provide investigators with access to the clinical specimens required for their basic and translational research activities.

For the first function, the goals of the core include establishing procedures and providing assistance with

• Study design, including study population identification, sample size and power estimates
• Outcomes research, including database research
• Data management including design, development and maintenance of study databases
• Biostatistical analysis, including plans for Institutional Review Board (IRB) applications, pilot and feasibility grants, NIH proposals, and manuscripts
• Proposal editing and Spanish language translation services are provided for those investigators that need that support

For the second function, the core performs and facilitates the collection of biospecimens for translational research that bridges clinical and basic research observations into patient-oriented protocols aimed at prevention, diagnosis, and treatment of digestive diseases. The core also provides a link to relevant regional and national tissue banks and provides samples from its own bank. It provides as much assistance as needed, up to and including, the actual completion of appropriate documentation, consents, and obtaining tissues needed by investigators. It provides assistance to investigators regarding interactions with IRB at Baylor and R&D committee at the VA and well as help in obtaining an IND or NDA if needed for the research. All of these services are available to both clinical and basic science investigators.

This core also offers assistance as well as didactic training in issues involving local and foreign IRB’s, HIPPA regulations, and importing or exporting clinical specimens. This core is designed to help traverse the gap in bidirectional exchange of knowledge between the basic scientists and clinical investigators; translating from the laboratory to the population. In addition, this year we have added the services of a Health Services Researcher, Dr. Jennifer Kramer, who assists investigators at the VA who are interested in using the VA administrative data to answer important research questions related to various GI conditions. To request services, please click here.