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 compliance, attaining high-quality samples linked to large clinical phenotypic information through integration of diverse databases and, innovative application of statistical tools. The following specific resources represent the foundation of the Clinical Translational Core of the Liver Center:
- A Clinical Core Research Coordinator with particular 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; and to ensure the protection of human research participants. In addition to being in charge of ensuring that all regulatory requirements for Liver Center protocols are met, the coordinator trains Liver Center staff and/or study coordinators on the requirements and best practices so that compliance can be maintained. This ensures that all Liver Center clinical studies follow local and federal guidelines.
- Liver Center Clinical Registry that consists of 1) Patient Databases, that include a prospective database of patients attending the outpatient liver clinics at Yale and the CT-VA Healthcare System (that is referred to as the Patient Registry of the Clinical Core or PaRCC). Patients in the PaRCC 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 (SaRCC). 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). 2) The Serum and Tissue Bank that is referred to as the Sample Registry of the Clinical Core (or SaRCC) and currently consists of frozen samples of serum and EDTA plasma (for DNA) obtained from patients included in the PaRCC. It also consists of liver biopsy slides and paraffin blocks stored at the Pathology Departments of both Yale and the VA. Both the PaRCC and the SaRCC 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.
- A Biostatistician that provides 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.
Investigators interested in using the Clinical and Translation Core services should contact the program coordinator, Randolph de la Rosa at 203-785-5237 or firstname.lastname@example.org.