This program supports patient-oriented clinical research focusing on digestive diseases. Small clinical studies (pilot), planning grants or phase III clinical trials may be appropriate to this program. The small clinical studies should focus on research that is innovative and/or potentially of high impact. They should lead to full scale clinical trials. Please see the current program announcement for small grants for clinical trials. Phase III clinical trials usually are multi-center and involve several hundred human subjects that are randomized to two or more treatments, one of which is usually a placebo. The aim of the trial is to provide evidence for support of, or a change in, health policy or standard of care. The interventions/treatments may include pharmacologic, nonpharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Areas of emphasis include: Helicobacter pylori; inflammatory bowel disease; functional bowel syndrome and constipation; non-ulcer dyspepsia; celiac disease; intestinal failure, short gut syndrome and small bowel transplantation.
Clinical trials may be funded by one of several mechanisms: a research project grant, a cooperative agreement, a planning grant, or a contract. Please see the current program announcement for small grants for clinical trials.
For more information, contact Dr. Jill Smith, Senior Scientific Advisor, Clinical and Translational Research in Digestive Diseases.