Statistical and Data Management Core

– Statistical and Data Management Core Chronic infection with hepatitis B virus (HBV) is estimated to be 317 million people worldwide and approximately, with 10% of people with HIV (PWH) affected, and 900,000 individuals die each year of HBV related cirrhosis and carcinoma. Furthermore, HBV is projected to rise to 1.2 million deaths by 2040. Therefore, HBV treatment must be substantially expanded in order to prevent HBV from becoming the leading cause of infectious disease mortality. Unfortunately, the present requirement of indefinitely treating individuals is a huge hurdle for public health and therefore a cure for chronic hepatitis B (CHB) would alleviate this challenge. The overall goal for establishing the Hepatitis B HIV Cure Consortium (BICC) is to promote cure of chronic hepatitis B virus (CHB) infection by establishing and characterizing a multinational cohort representing the global diversity of PWHHB that provides a platform to investigate critical questions to advance cure. The goal of the Statistical and Data Management Core (SDMC) is to ensure high quality contemporary research is carried out in terms of formulating research questions, study design, data management, and analyses of the projects included within this U19. The SDMC in close collaboration with the U19 Administrative, Shared Resources, Metabolomics, and Virology cores and the Clinical, Immunology, and Translational Projects to pursue critical questions in order to further HBV cure research. The first aim is to provide statistical and epidemiological expertise for the design, analysis, and interpretation of studies related to the scientific goals of BICC. The second aim is to manage and assure the quality of the data across the BICC sites including (i) the provision of secured systems for transferring, editing, storing, and backing up the data, (ii) deriving analytical datasets for analysis of HBV scientific questions regardless of whether as a part of the accompanying U19 (clinical, translational, immunology) projects or projects submitted by non-BICC investigators and approved by BICC leadership and (iii) managing data for the submission to data archives allowing for outside investigators to use. The third aim is to implement the scientific agenda, including developing procedures for standardized execution of protocols across sites in collaboration with the Administrative, Shared Resources, Multiomics, and Virology Cores, and the proposed Clinical, Immunology, and Translational Projects. Successful research is accomplished by creating comprehensive partnerships that provide transdisciplinary expertise throughout the entire research process, from the beginning with the conceptualization of the research question through all steps to publication. Innovation and improved research insights are obtained when collaborations integrate novel and improved methodology, uncovering further methodological challenges and motivating new areas for research. By collaborating with the BICC cores and projects, SDMC will increase the likelihood of success of ARCH in achieving its overall project goals. Project Number: 1U19AI188551-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Allergy and Infectious Diseases (NIAID) | Principal Investigator: Bryan Lau | Institution: JOHNS HOPKINS UNIVERSITY, BALTIMORE, MD | Award Amount: $500,697 | Activity Code: U19 | Study Section: Special Emphasis Panel[ZAI1 KSW-A (S1)] View on NIH RePORTER: https://reporter.nih.gov/project-details/1U19AI18855101