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Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies.

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Date
2014-07
Authors
Sanchez, Ana M
Denny, Thomas N
O'Gorman, Maurice
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Abstract
This Special Issue of the Journal of Immunological Methods includes 16 manuscripts describing quality assurance activities related to virologic and immunologic monitoring of six global laboratory resource programs that support international HIV/AIDS clinical trial studies: Collaboration for AIDS Vaccine Discovery (CAVD); Center for HIV/AIDS Vaccine Immunology (CHAVI); External Quality Assurance Program Oversight Laboratory (EQAPOL); HIV Vaccine Trial Network (HVTN); International AIDS Vaccine Initiative (IAVI); and Immunology Quality Assessment (IQA). The reports from these programs address the many components required to develop comprehensive quality control activities and subsequent quality assurance programs for immune monitoring in global clinical trials including: all aspects of processing, storing, and quality assessment of PBMC preparations used ubiquitously in HIV clinical trials, the development and optimization of assays for CD8 HIV responses and HIV neutralization, a comprehensive global HIV virus repository, and reports on the development and execution of novel external proficiency testing programs for immunophenotyping, intracellular cytokine staining, ELISPOT and luminex based cytokine measurements. In addition, there are articles describing the implementation of Good Clinical Laboratory Practices (GCLP) in a large quality assurance laboratory, the development of statistical methods specific for external proficiency testing assessment, a discussion on the ability to set objective thresholds for measuring rare events by flow cytometry, and finally, a manuscript which addresses a framework for the structured reporting of T cell immune function based assays. It is anticipated that this series of manuscripts covering a wide range of quality assurance activities associated with the conduct of global clinical trials will provide a resource for individuals and programs involved in improving the harmonization, standardization, accuracy, and sensitivity of virologic and immunologic testing.
Type
Journal article
Subject
CAVD
CHAVI
EQAPOL
HVTN
IAVI
IQA
AIDS Vaccines
Acquired Immunodeficiency Syndrome
Clinical Trials as Topic
Consensus
Cooperative Behavior
Guideline Adherence
HIV Infections
Humans
Immunologic Tests
International Cooperation
Laboratories
Laboratory Proficiency Testing
Monitoring, Immunologic
Observer Variation
Practice Guidelines as Topic
Predictive Value of Tests
Program Development
Program Evaluation
Quality Control
Reproducibility of Results
Treatment Outcome
Permalink
https://hdl.handle.net/10161/14680
Published Version (Please cite this version)
10.1016/j.jim.2014.05.016
Publication Info
Sanchez, Ana M; Denny, Thomas N; & O'Gorman, Maurice (2014). Introduction to a Special Issue of the Journal of Immunological Methods: Building global resource programs to support HIV/AIDS clinical trial studies. J Immunol Methods, 409. pp. 1-5. 10.1016/j.jim.2014.05.016. Retrieved from https://hdl.handle.net/10161/14680.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Denny

Thomas Norton Denny

Professor in Medicine
Thomas N. Denny, MSc, M.Phil, is the Chief Operating Officer of the Duke Human Vaccine Institute (DHVI), Associate Dean for Duke Research and Discovery @RTP, and a Professor of Medicine in the Department of Medicine at Duke University Medical Center. He is also an Affiliate Member of the Duke Global Health Institute. Previously, he served on the Health Sector Advisory Council of the Duke University Fuquay School of Business. Prior to joining Duke, he was an Associate Professor of Pathology, Labo
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