The Digestive Diseases Clinical Research and Epidemiology program supports patient-oriented clinical research and epidemiology research in digestive diseases. The program supports small clinical studies focused on research that is innovative and of potential high impact and should lead to full-scale clinical trials. The program encourages Phase III clinical trials, which are typically multi-center and involve several hundred patients randomized to two or more treatments, one of which is usually a placebo. The aim of such trials is to provide evidence for support of, or a change in, health policy or standard of care. Studied treatments may include pharmacologic, nonpharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy. The program’s research portfolio includes studies on: Helicobacter pylori; inflammatory bowel disease; functional bowel disorders and constipation; nonulcer dyspepsia; celiac disease; intestinal failure; short gut syndrome; and small bowel transplantation.
This program also serves as a focal point for the collection, analysis, and dissemination of data on digestive diseases and their complications. The program encourages research that addresses risk factors for disease occurrence and disease prognosis or natural history. The program also supports databases and biological repositories that advance clinical and epidemiological studies in digestive diseases and nutrition. Specific areas of focus for this program include: identifying the data needed to address the scientific and public health issues in digestive diseases and nutrition; addressing the epidemiology of digestive diseases and nutritional disorders of public health significance, with particular emphasis on national surveys and their follow-up; promoting the timely availability of reliable data to pertinent scientific, medical, and public organizations; standardizing data collection and terminology in clinical and epidemiological research; and working closely with members of the scientific community to develop investigator-initiated research in digestive diseases and nutrition epidemiology.