TMC Digestive Diseases Center Study Design & Clinical Research Core

The major functions of the Study Design & Clinical Research Core are to:

• Serve clinical and basic science investigators in digestive diseases with comprehensive study design consultation and support
• Assist DDC investigators in all aspects of the acquisition of clinical specimens required for their research in digestive diseases
• Develop disease-specific databases and repositories, and support comprehensive data analyses and interpretation of basic, translation, clinical and epidemiological studies.

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. 

Fasiha Kanwal, M.D., M.S.H.S., serves as clinical core director. She is a professor of medicine, chief of the gastroenterology and hepatology section at Baylor College of Medicine, and a well-established clinical investigator with active funding from NIH, VA, and DOD. 

David Graham, M.D., a renowned clinical investigator and co-founder emeritus of the DDC itself, continues to serve as the core co-director. 

Mimi Tan, M.D., M.P.H, (T32-trained, P/F awardee and K23 holder) serves as assistant director of the clinical core. 

The clinical core provides subsidized consultative support to DDC members in four main areas:

1. Study design,
2. Access to clinical specimens for translational, clinical, and epidemiological studies, 
3. Develop disease-specific databases and repositories, and
4. Statistical analyses and interpretation.

To request services from any DDC core facility, visit our iLab Solutions portal.