Clinical and Translational Core

The overarching goal of the Clinical Core is to facilitate translational and patient-oriented research. The Clinical Translational Core aims to develop an infrastructure for patient-oriented research by streamlining regulatory and compliance processes, obtaining and storing high-quality samples linked to extensive clinical phenotypic information, offering expert consultation in the design and implementation of patient-oriented trials, and supplying statistical expertise for application of innovative analytic methods in translational and patient-oriented research.

• Expertise in effectively addressing NIH, IRB and HIPAA policies and reporting requirements concerning confidentiality, inclusion of women, children and ethnic/minority participation in clinical studies, data and safety monitoring requirements
• Ensure the protection of human research participants
• Ensuring that all regulatory requirements for Liver Center protocols are met
• Trains Liver Center staff and/or study coordinators on the requirements and best practices so that compliance can be maintained, ensuring that all Liver Center clinical studies follow local and federal guidelines

Patient Registry of the Clinical Core

Patient Databases, that include a prospective database of patients attending the outpatient liver clinics at Yale and the CT-VA Healthcare System. Patients in this registry have given specific consent to be contacted for possible participation in future clinical studies and most of them have also consented to provide samples for the serum and tissue bank. Other liver disease-specific databases available to Center members include those of patients with compensated and decompensated cirrhosis, acute-on-chronic liver failure, hepatitis C, hepatocellular carcinoma (HCC), autoimmune liver disease and inherited metabolic liver diseases (Gaucher and Wilson disease).

Sample Registry of the Clinical Core

The Serum and Tissue Bank currently consists of over 10,000 frozen samples of serum and EDTA plasma (for DNA) obtained from patients included in the patient registry. It also consists of liver biopsy slides and paraffin blocks stored at the Pathology Departments of both Yale and the VA. Both the patient and sample registry are linked and maintained by the Clinical Core Research Coordinator with the objective of providing Center members with data regarding numbers of patients with specific diagnoses seen at the Center in a defined period of time to assess the feasibility of a specific study, contact patients for participation in a study and provide serum/tissue samples for use in research. The Clinical Core has also established collaboration with the Yale Center for Clinical Investigations (YCCI) through its Biorepository Core that is responsible for the processing, storing and tracking of blood and tissue samples through the Clinical Core, as well as maintaining the database for the samples in storage.

Investigators interested in obtaining more information or samples should send requests to Bonnie Chen.

The Liver Center has two biostatisticians that provide assistance to basic researchers with clinical study design, particularly for small pilot projects that are the initial step in the translational process. For established clinical investigators using the clinical component, this resource provides consultation for clinical study/trial development particularly in establishing sample size calculations and advice regarding the most appropriate study design. Furthermore, biostatistical analysis of patients already in liver disease-specific databases continue to provide new insights into the natural history of these heterogeneous disorders.

For more information, please contact our biostatisticians Yanhong Deng.