The Data Management and Biostatistics Core will build the physical infrastructure, software solutions and human resources for a centralized, web-based fully GCP-compliant data management system and a program-wide data warehouse and provide support for the analyses of complex longitudinal data systems. The Core will serve the data storage and analytic needs of the 3 Research Projects conducted in all malaria endemic sites ofthe ICEMR and interact directly with the Molecular Diagnostics Core that will create an archive of biological samples and perform diagnostic tests related to malaria infections of humans and mosquitoes.
The Specific Aims are to: 1: Set up a robust and comprehensive, centralized, web-based fully GCP-compliant data management system for ICEMR program 2;Create a collaborative environment between Papua New Guinea and participating sites in Solomon Islands and other ICEMR institutions and countries for the design, development, testing, and implementation of the data management system 3: Establish a centralized data repository that provides secure access to researchers and collaborators 4: Develop adequate data analysis tools for the analyses of complex longitudinal datasets (with multiple endpoints) 5: Analyze data and prepare results in a timely manner for interim analyses, publications, and presentations 6;Ensure regulatory compliance of data collection management 7: Provide training and development opportunities to Papua New Guinea and Solomon Islands in the areas of epidemiology, biostatistics, and database architecture The core will be directed by Prof. John Aponte from CRESIB, where he has organized similar data systems for large scale malaria epidemiology studies and clinical trials in Sub-Saharan Africa, and supported by Dr. Ivo Mueller, leader ofthe Epidemiology Project, and Thomas Adiguma, senior data manager at PNGIMR. Infrastructure and capacity building will be accomplished by the provision of training and resources in the fields of epidemiology, biostatistics, and dataset architecture.

Public Health Relevance

Sophisticated relational database management, compliance with Good Clinical Practice and advanced biostatistical analysis are all essential to the conduct of ethical research related to the control and elimination of malaria. The Data Management and Biostatistics Core will serve this essential function forthe ICEMR.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1-AWA-M)
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Case Western Reserve University
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Lerch, Anita; Koepfli, Cristian; Hofmann, Natalie E et al. (2017) Development of amplicon deep sequencing markers and data analysis pipeline for genotyping multi-clonal malaria infections. BMC Genomics 18:864
Messerli, Camilla; Hofmann, Natalie E; Beck, Hans-Peter et al. (2017) Critical Evaluation of Molecular Monitoring in Malaria Drug Efficacy Trials and Pitfalls of Length-Polymorphic Markers. Antimicrob Agents Chemother 61:
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Koepfli, Cristian; Nguitragool, Wang; Hofmann, Natalie E et al. (2016) Sensitive and accurate quantification of human malaria parasites using droplet digital PCR (ddPCR). Sci Rep 6:39183
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