About
Although tuberculosis (TB) is a curable and preventable disease, it remains one of the most significant infectious causes of mortality and morbidity worldwide and the leading cause of death among people living with HIV. TB is a global public health challenge; in 2023, the World Health Organization identified an estimated total of 10.8 million people affected. Given its high prevalence and disproportionate impact, the FEND for TB Consortium aims to evaluate early-stage and novel diagnostic strategies within the framework of existing clinical algorithms in TB-endemic countries.
Persistent delays and gaps in diagnosis continue to hinder TB control – an estimated one-third of all cases go undetected. Missed or late diagnoses contribute to ongoing transmission, poor health outcomes, and a greater economic burden. While the past decade has seen important advances in TB diagnostics, particularly for sputum-based testing, significant limitations remain. These include poor feasibility in individuals unable to expectorate, limited utility in extra-pulmonary TB or latent infection, and biosafety risks associated with specimen collection. Substantial innovation is still required to
develop diagnostics capable of overcoming such challenges and reliably detecting both TB exposure and drug resistance.
Our Mission
To support the evaluation of early-stage TB diagnostics & novel diagnostic strategies in the context of existing clinical algorithms in TB endemic countries.
FEND for TB will perform proof-of-principle studies of novel diagnostics & strategies and provide feedback to diagnostic developers on the performance of the technologies and their most effective use in endemic settings.
Leadership
The FEND-TB consortium is led by a dynamic team of expert investigators with decades of experience in the conduct of multicenter, multidisciplinary international research programs and diagnostic evaluation programs on TB.
Dr. Ellner has led multidisciplinary observational cohort programs at international sites comparable in scope to FEND-TB including currently TBRU, RePORT India and RePORT South Africa. Dr. Alland is internationally recognized for his contributions to TB diagnostic research and understanding of mechanisms of drug resistance. Dr. Dorman has been PI on sentinel studies of TB diagnostics including currently a large RO1 for further study of Xpert Ultra as well as clinical trials of new treatments including a multicenter trial of rifapentine for treatment shortening. Dr. Ellner was PI, Dr. Dorman Clinical Director and Dr. Alland Scientific Director of the NIAID TB-Clinical Diagnostics Research Consortium (TB-CDRC) from 2009-2016.
Jerrold Ellner
PI
Susan Dorman
Co-PI & Clinical Director
David Alland
Co-PI & Scientific Director
Jerrold Ellner, MD
Principal Investigator
Susan Dorman, MD
Co-PI & Clinical Director
David Alland, MD
Co-PI & Scientific Director
The program is enhanced by a small and responsive Leadership Committee and an Executive Committee with representation across the consortium. Several cores and committees represent the service lines of the FEND-TB program. The FEND-TB leadership is comprised of leading innovators in their respective TB fields. Many have collaborated together for over a decade, discovering TB biomarkers, developing infectious disease diagnostics, modeling diagnostic impact; and most importantly, leading innovative high-quality clinical studies.
Operations
Rutgers University’s Center for Emerging Pathogens hosts the Data and Operations Management Center (DOMC), which is dedicated to the operations and conduct of sponsored clinical studies. The DOMC currently coordinates and manages 12 NIH-sponsored UO1 and R01 projects involving human prospective clinical studies across eleven TB-endemic countries. These studies span adult, pediatric, and MDR-TB populations and focus on biomarker discovery, diagnostic test evaluation, and epidemiology/genomics.
The DOMC has extensive experience serving as the Data, Administrative, and Operations Management Center for numerous TB research programs, including TB CDRC (2009–2016), TB Research Unit (2014–2021), FEND-TB (2020–2025), QFT (2020–2023), LTBI COVID (2021–2023), TB-RePORT International Coordinating Center (2021–2028), Halting TB (2020–2025), TBRU 2 (2021–2026), and ICIDR programs. Core activities include biomarker discovery, evaluation of point-of-care TB diagnostics, design and development of case report forms, data entry and management, operational implementation, quality assurance, statistical analysis, study data maintenance, clinical coordination, biorepository management, and documentation and regulatory compliance.
FEND-TB Conflict of Interest Disclaimer
The Feasibility of Novel Diagnostics for TB in Endemic Countries (FEND-TB) program, led by Rutgers University in collaboration with multiple global partners, includes investigators who may have research-related relationships with diagnostic manufacturers. These relationships may involve receipt of research support, equipment, reagents, or other resources provided for independent evaluation under appropriate institutional oversight.
All FEND-TB evaluations are conducted according to established scientific and ethical standards, with full adherence to institutional conflict-of-interest policies and procedures. The presence of such relationships does not influence the objectivity, integrity, or independence of the evaluation process.
Data and Operations Management Center
Database Management
Biorepository Management
Clinical Data Collection
Database Management
The Data and Operations Management Center (DOMC) exports REDCap collected data into interim Access databases for review, query and resolution per SOP and GCP guidelines.
Data interns and study coordinators work with site teams to establish valid and complete data for statistical analyses.
Biorepository Management
DOMC utilizes FreezerPro Cloud, a web-based samples management solution (Chelmsford, MA) and sample tracking solution, to manage biospecimens across institutions. Creation of virtual freezers assists with management and identifies source vials by “pull lists” when needed for analysis or to digitally accompany shipments to other laboratories. FEND-TB sites adhere to GCP and GLP in the secure storage of participant samples.
Clinical Data Collection
DOMC utilize HIPAA-compliant REDCap (Research Electronic Data Capture, Vanderbilt University) tools to provide a secure, web-based application allowing for
- Validated data entry
- Audit trails of all data entry, manipulation, and export
- Customizable reports and exports to all common statistical packages
- Tools for seamless data import
- Customizable user access permissions. REDCap allows for direct on- or off-line electronic data capture.
Data Visualization
Data Dashboards
DOMC utilizes Tableau Software to create dashboards composed of dynamic visuals communicating clinical data and summarizing biorepository inventory.
FEND-TB Status
Benefits
- Represent and analyze collected data
- Evaluate clinical and biorepository needs
- Curate a wide variety of graphs for easy interpretation
- Easily share content with many via servers
FEND-Sex and HIV Status
FEND-Cumulative Enrollment