# SDMC - IMPAACT Leadership Group

> **NIH NIH UM1** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2021 · $12,235,847

## Abstract

Project Summary/Abstract
This application requests renewal of funding to serve as the Statistical and Data Management
Center of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network
(IMPAACT). IMPAACT is an international clinical trials network which is proposing to address
objectives in NIAID high priority research areas for infants, children, adolescents, and pregnant
and breastfeeding women living with HIV. Specifically: to evaluate novel and durable
interventions targeting HIV infection; to identify strategies to reduce HIV reservoirs and control
HIV replication in the absence of antiretroviral treatment (“ART-free remission”); to improve the
diagnosis and treatment of tuberculosis, especially in those co-infected with HIV; and to improve
the prevention and treatment of complications and co-infections of HIV.
The application's specific aims and long-term objectives are: to support the international
research agenda of IMPAACT by providing a group of highly-experienced statisticians,
epidemiologists, data managers and other professionals who have a deep interest in research in
HIV infection and its complications and co-infections; to support the development, conduct and
analysis of IMPAACT studies with expert statistical and data management leadership and high
quality clinical and laboratory data management and communications systems which comply
with regulatory requirements, meet industry standards and are fully integrated into quality
management system workflows; and to advance the mission of IMPAACT through innovation in
study design and analysis and the development of efficient methods and systems, that facilitate
the work of IMPAACT and promote harmonization and data sharing with collaborating
organizations.
The proposed SDMC consists of two components. One is a Statistical and Data Analysis
Center at Harvard T.H. Chan School of Public Health which will provide biostatistical leadership.
The second is a Data Management Center at Frontier Science & Technology Research
Foundation which will provide expertise and leadership in data management systems and has
primary responsibility for data collection, quality and integrity.

## Key facts

- **NIH application ID:** 9988037
- **Project number:** 2UM1AI068616-15
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** Marlene Ann Cooper
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $12,235,847
- **Award type:** 2
- **Project period:** 2006-06-29 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9988037

## Citation

> US National Institutes of Health, RePORTER application 9988037, SDMC - IMPAACT Leadership Group (2UM1AI068616-15). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9988037. Licensed CC0.

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