Clinical Research

Clinical research is patient-oriented research. Research may be conducted in human volunteers or on samples from humans. NIH-funded studies are carefully designed to answer specific medical questions while protecting participants' safety. Well conducted clinical trials are the fastest and safest way to find improved treatments and preventions for diseases. Clinical trials or interventional trials determine whether experimental preventions, treatments, or new ways of using known therapies are safe and effective under controlled conditions. Observational or natural history studies examine health issues and disease development in groups of people or populations. Understanding Clinical Trials Understanding Clinical Trials

NIDDK-Funded Clinical Research

• Biliary Atresia Research Consortium (BARC): Biliary atresia, although a rare disease, is the most common reason for liver transplantation in children. The cause of biliary atresia remains elusive and its optimal management is still unsettled. It is often clinically difficult to distinguish biliary atresia from other causes of neonatal liver disease such as neonatal hepatitis and inherited forms of neonatal cholestasis. Yet early identification and diagnosis are crucial for the outcome of biliary atresia. The optimal management of biliary atresia appears to depend upon the performance of a portoenterostomy (Kasai procedure) within the first 60 days of life. Even with a successful portoenterostomy, progressive liver disease can follow and result in the need for liver transplantation within the first 5 to 10 years of life. The determinants of success for portoenterostomy and the most accurate means of diagnosis, and staging of biliary atresia are not well defined. Furthermore, there are too few new cases of this disease seen each yearat single pediatric liver disease centers to allow for intensive analyses of risk factors or to critically assess different means of diagnosis and treatment. The Biliary Atresia Research Consortium (BARC) is a NIH-funded collaborative consortium of 9 pediatric liver disease and transplant centers and a central data coordinating center, the goal of which is to gather prospectively adequate numbers of patients with full clinical data, serum and tissue samples to facilitate research and generate hypotheses on the pathogenesis and optimal treatment of biliary atresia and other neonatal cholestatic disorders. BARC is specifically designed to provide patient and sample resources for collaborative studies with other researchers and to provide a network of clinical investigators to design and conduct clinical trials of new diagnostic tests, imaging studies and therapies for biliary atresia. For more information and a list of participating centers, go to http://www.med.umich.edu/borc/barc/index.htm.
  
  
• Adult To Adult Living Donor Liver Donor Liver Transplantation Cohort Study (A2ALL)
  Liver transplantation has become the standard of care and the only cure for end-stage liver disease. However, of the people needing liver transplants in a given year, only a third will get organs donated from cadavers. Living donor transplants have been very successful in children, and many liver transplant Programs now use living donors for adult patients. However, no data exist to guide either doctors, donors, or recipients in evaluating risks and benefits. The A2ALL study is a seven-year project at 10 centers across the country. It seeks to identify factors that influence outcomes for both live donors and recipients by comparing the outcomes of these patients to a cohort who received livers from cadavers. A2ALL is also supported by the American Society of Transplant Surgeons and the Health Resources Services Administration. For further information and a list of participating centers, www.niddk.nih.gov/welcome/releases/10-09-02.htm and www.nih-a2all.org/.
  A2ALL: Opportunities for Collaborations *(PDF,78KB)



• Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial
  HALT-C is a multicenter randomized clinical trial to determine if four years of interferon therapy can prevent progression of liver disease in persons with severe liver injury who have not cleared hepatitis C virus with standard therapy.



• ClinicalTrials.gov
  For other studies in digestive diseases, search this comprehensive database.

* This file is in PDF format, which requires the free Adobe Acrobat Reader for viewing.