# Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)

> **NIH NIH UM1** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2022 · $944,359

## Abstract

Project Summary/Abstract
This application requests renewal of funding to serve as the Statistical and Data Management
Center of the AIDS Clinical Trials Group (ACTG). The ACTG is an international clinical trials
network which is proposing to address objectives in NIAID high priority research areas for adults
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 ART
(“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 co-morbidities and
co-infections, including curative strategies hepatitis B virus co-infection.
The application's specific aims and long-term objectives are: to support the international
research agenda of the ACTG 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 ACTG 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 the ACTG through innovation in
study design and analysis and the development of efficient methods and systems, that facilitate
the work of the ACTG 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,
and includes a subcontract to University of California San Francisco to support additional
tuberculosis trial design expertise. 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:** 10694524
- **Project number:** 3UM1AI068634-16S1
- **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:** 2022
- **Award amount:** $944,359
- **Award type:** 3
- **Project period:** 2006-06-29 → 2027-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10694524

## Citation

> US National Institutes of Health, RePORTER application 10694524, Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG) (3UM1AI068634-16S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10694524. Licensed CC0.

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