# Clinical Core

> **NIH NIH U19** · RBHS-NEW JERSEY MEDICAL SCHOOL · 2020 · $618,699

## Abstract

The TBRU will operate a Clinical Core directed by Dr. Horsburgh of the Boston University School of Public
Health. The Clinical Core will take overall responsibility of all human studies in the proposed TBRU
protocols and will work closely with the Regulatory Coordinator and Data Management Center (DMC) in the
Administrative Core to coordinate approved protocols and unit-wide scientific activities in concert with
scientific decisions of the TBRU. The TBRU Clinical Core will oversee the development and implementation
of the clinical projects, including protocol development, regulatory approvals, data management, and site
monitoring.
The human studies will be conducted at the NiJcleo de Doencas Infecciosas (NDI) in Vitoria, Brazil led by Dr.
Reynaldo Dietze, and the National Medical Center (NMC) in Seoul, Republic of Korea (ROK) led by Dr. Ray
Cho. Dr. Horsburgh will work closely with Drs. Dietze and Cho to ensure timely completion of all project
milestones. The Clinical Core will coordinate with the existing NIAID intramural team in the ROK, and the
established ICIDR study team in Brazil when the TBRU projects begin.
There are parallels in the studies to be conducted in South Korea and Brazil. In Project 1, prospective
observational cohort studies of household contacts of multidrug resistant (MDR)-PTB (Korea) and of drug-susceptible
(DS) -PTB (Brazil) will be conducted. The endpoint will be incident TB. In Project 3, a
prospective observational cohort study of MDR-TB cases (Korea) and DS-PTB cases (Brazil) beginning at
the end of treatment will be conducted, the endpoint being relapse. In both projects, samples will be
collected and stored, and then accessed when a subject reaches a study endpoint along with samples from
suitable controls. There is considerable overlap as well in the approaches to biomarker discovery.

## Key facts

- **NIH application ID:** 10004555
- **Project number:** 5U19AI111276-08
- **Recipient organization:** RBHS-NEW JERSEY MEDICAL SCHOOL
- **Principal Investigator:** David Alland
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $618,699
- **Award type:** 5
- **Project period:** 2014-08-01 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10004555

## Citation

> US National Institutes of Health, RePORTER application 10004555, Clinical Core (5U19AI111276-08). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10004555. Licensed CC0.

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