# Statistical and Data Management Center (SDMC): Microbicide Trials Network

> **NIH NIH UM1** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2021 · $3,470,954

## Abstract

The Microbicide Trials Network (MTN) was on track to complete crucial studies assessing the safety of the
dapivirine vaginal ring in adolescents, pregnant women and breastfeeding women within the current project
period. Unfortunately, this work is being delayed as a result of the COVID-19 associated disruption of study
activities. To address these delays, the MTN Statistical and Data Management Center (MTN SDMC) is
requesting a one-year extension of funding (UM1AI068615) to support these critical clinical trials as well as
for the completion of the analyses of completed trials which have been interrupted due to the COVID-19
epidemic. Through this extension, the MTN SDMC will continue to support the development of a safe and
effective microbicide for HIV prevention by: 1. Ensuring the collection of complete, high quality data by
providing state-of-the-art secure data management systems and training according to best data and clinical
management practices. 2. Providing statistical and leadership and support throughout the protocol
development and implementation process, including study design, monitoring and analysis and reporting.
The MTN SDMC has extensive experience in the design, conduct and analysis of HIV prevention studies,
including studies of the dapivirine vaginal ring. The scientific leadership of the faculty engaged in the MTN
SDMC will ensure MTN trials are designed to obtain reliable answers to the most pressing questions in
microbicides development. Our systems for data collection, management, monitoring and analysis are all
well tested and in accordance with ICH guidelines. We will support the leadership group with timely and
accurate reporting of MTN studies throughout follow-up to study completion. We will continue to support the
MTN LC program through coordination of specimens and assay results, and with statistical analysis and
methods development. MTN SDMC statisticians will develop and deploy statistical methodologies to
increase the efficiency and rigor of the proposed program of microbicide trials.

## Key facts

- **NIH application ID:** 10175633
- **Project number:** 4UM1AI068615-15
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Elizabeth Renata Brown
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $3,470,954
- **Award type:** 4C
- **Project period:** 2006-06-29 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10175633

## Citation

> US National Institutes of Health, RePORTER application 10175633, Statistical and Data Management Center (SDMC): Microbicide Trials Network (4UM1AI068615-15). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10175633. Licensed CC0.

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