This application to continue as the Statistical and Data Management Center (SDMC) for the Microbicide Trials Network (MTN) is one of three applications comprising the Leadership Group of the MTN. To address the overall scientific goal described in RFA-AI-12-008, the development of a safe and effective microbicide for HIV prevention, the MTN SDMC scientific agenda includes the following aims: 1. Ensure 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. Provide statistical and epidemiologic leadership and support throughout the protocol development and implementation process, including study design, monitoring and analysis and reporting. 3. Develop and implement innovative statistical and epidemiological approaches to improve the scientific understanding of HIV risk, how microbicides reduce this risk and how this reduction may be modified or influenced by biological and behavioral factors. The MTN SDMC has extensive experience in the design, conduct and analysis of HIV prevention studies. 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. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New microbicides will be developed through a sequence of Phase 1, 2 and 3 trials. 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. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of microbicide trials.

Public Health Relevance

The HIV/AIDS epidemic continues to affect many regions of the world and HIV vulnerable populations are in need of safe, cost-effective, convenient and discreet methods to protect themselves from acquiring HIV. Microbicides have the potential to deliver this protection. The MTN SDMC will provide the highest quality of clinical trial design, data management and statistical analysis to ensure scientifically sound and robust results for MTN trials.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
2UM1AI068615-08
Application #
8552185
Study Section
Special Emphasis Panel (ZAI1-RRS-A (S1))
Program Officer
Black, Roberta J
Project Start
2006-06-29
Project End
2020-11-30
Budget Start
2014-01-01
Budget End
2014-11-30
Support Year
8
Fiscal Year
2014
Total Cost
$2,752,924
Indirect Cost
$1,083,796
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
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Justman, Jessica E; Nair, Gonasagrie Lulu; Hendrix, Craig W et al. (2018) Pharmacokinetics and Pharmacodynamics of Tenofovir Reduced-Glycerin 1% Gel in the Rectal and Vaginal Compartments in Women: A Cross-Compartmental Study With Directly Observed Dosing. J Acquir Immune Defic Syndr 78:175-182
Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E et al. (2018) Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials 19:8-14
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