Biliary Atresia Clinical Research ConsortiumAmerican Liver Foundation Last year, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announced the creation of the Biliary Atresia Clinical Research Consortium. Dr. Philip Rosenthal, a member of the ALF Children's Liver Council, was accepted to take part in the study. The following is his report on the operations of the Consortium... Philip Rosenthal, MD, Professor of Pediatrics & Surgery  The Biliary Atresia Clinical Research Consortium (BARC) is composed of 9 sites throughout the United States that will focus on the study of biliary atresia. This is a significant accomplishment as it signifies the first ever specific governmental study targeted at a comprehensive investigation of biliary atresia, the leading indication for liver transplantation in children in the United States. The sites selected for this important study include: University of California, San Francisco; University of Colorado; Washington University, St. Louis; Children's Hospital, Cincinnati; Children's Hospital, Pittsburgh; Mt. Sinai, New York; Children's Hospital of Philadelphia; Johns Hopkins University, Baltimore; and Children's Memorial Hospital, Chicago. A Data Coordinating Center (DCC) at the University of Michigan is responsible for organizing meetings and teleconferences and for collecting the samples and data. NIDDK staff serve as advisors to the study and include Drs. Jay Hoofnagle, Jay Everhart and Leonard Seeff. Pat Robuck serves as the Project Officer for the study from NIDDK. A number of committees are being developed that will be responsible for specific aspects of the study. The Executive Committee will be responsible for managing day-to-day major issues of BARC; making decisions in periods between steering committee meetings, organizing and setting the agenda for the steering committee meetings, and providing oversight of the study. The Steering Committee is the major decision making body for BARC and provides oversight in the planning and the conduct of the study. The Committee votes on all important decisions and approves the final database and protocol and any amendments or modifications of the protocol. The Committee consists of the principal investigators of each of the clinical centers, the principal investigator of the Data Coordinating Center, and the NIDDK project officer, each of whom has one vote in any decision requiring a formal vote. The Database Committee is responsible for preparing the final written database and protocol for the study, including the summary, background information, study design, inclusion and exclusion criteria, initial evaluation data, monitoring schedule, adverse event grading, statistical analysis, patient protection, and references sections of the protocol for the prospective database. A subcommittee of the Database Committee prepares the master consent form for the study. The details of the database design are developed by the database committee, but major decisions in the design and the final database protocol is approved by the Steering Committee. The Database Committee consists of a chair and at least three other principal investigators or co-principal investigators from the clinical centers as well as all members of the executive committee. The Tissue Repository and Pathology Committee will develop the pathological criteria for diagnosis, staging and grading of biopsy and surgical specimens of liver and extrahepatic biliary tissues. It will also develop the requirements for acquiring, processing, storing and shipping tissues, serum, and DNA specimens from subjects entered into the database protocol. Additional responsibilities include developing a system for diagnostic criteria for biliary atresia on liver biopsy and biliary tissues, grading the severity of liver lesions in biliary atresia and related diseases, and staging the degree of fibrosis. This committee will also make recommendations regarding a central pathologist to review all biopsies and surgical specimens, and make recommendations for the reading of histology by the local pathologists at each Clinical Center. The Tissue Repository and Pathology committee will assist in the analysis of data as relates to histological features. This committee consists of the lead pathologist from each of the Clinical Centers, one or two pathologists assigned by NIDDK, the two co-chairpersons of the BARC Network, three other principal investigators from the Clinical Centers, the Principal Investigator of the Data Coordinating Center, and an NIDDK staff member. The Pathogenesis Committee will develop protocols to help delineate the pathogenesis of biliary atresia using the resources of BARC clinical centers as well as possible outreach to other laboratory investigators. There will be two subcommittees, one focusing on Infections and Immunology and the other on Genetics and Genomics. The entire committee will review the various hypotheses for the cause of biliary atresia and add items to the database that will be necessary to determine the etiology and the pathogenesis of biliary atresia. This committee will provide advice regarding collaborations with other investigators who may provide resources and approaches to the study of biliary atresia. Each subcommittee consists of a chairperson and at least three principal investigators or co-principal investigators from the clinical centers, two designated members from the Data Coordinating Center and an NIDDK staff member. At least one member will be a surgeon. The Epidemiology and Outcomes Committee will develop hypotheses and questions to be answered by the database in regard to the epidemiology and etiology of biliary atresia, and assist with the development of the database items reflecting these issues. The committee will also identify major clinical outcome measures to be assessed by the database and make recommendations to the steering committee for the types of data that must be gathered on patients entered into the prospective database. The committee will be involved with the DCC in analysis of these data. This committee consists of a chairperson, at least three principal investigators or co-investigators from the clinical centers, one member from the Data Coordinating Center, and an NIDDK staff member. At least one member will be a surgeon. The Clinical Trials Committee will review and develop ideas for clinical trials and studies to be performed in patients entered into the prospective database. Initially, clinical trials in the grant applications will be reviewed and recommendations given to the steering committee. In the future, clinical trials that are proposed by the steering committee will be reviewed by this committee, and recommendations given to the steering committee. This consists of a chairperson, at least three principal investigators or co-principal investigators from the clinical centers, one member from the Data Coordinating Center, and an NIDDK staff member. At least one member will be a surgeon. The Publication Committee develops the policy for publications in regards to preparation of manuscripts, assignment of tasks in analysis and writing, policy as regards to requesting data analysis, authorship policy and other issues related to publications. The publications committee will prepare a format publication policy for both full manuscripts and abstracts. When the time is appropriate, the publication committee will prepare a list of possible publications that will arise from this study and prepare paragraphs regarding the scope of each. This committee consists of a chairperson, principal investigators from at least three clinical centers, a member of the Data Coordinating Committee, and a NIDDK representative. This is a brief introduction to BARC. I hope in the future to give you an update on the progress of the study, and perhaps obtain your help as we investigate the causes and potential new therapies for this disorder. If you would like to learn more about donating to the American Liver Foundation's fund for this cause, see: http://www.liverfoundation.org/donation.shtml
For more information, or to contact American Liver Foundation, see their website at: www.liverfoundation.org |
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