DATA GATHERING
WP3
WP3 will perform a search for databases that include individual patients’ data on bacterial infections, in particular those due to AMR.
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The partners involved have ample experience in gathering the databases from the different studies performed within the COMBACTE consortia as part of the COMBACTE-MAGNET (see WP1) project. Based on a predefined analysis plan to be accepted by the relative databases governance boards, GSK will facilitate data extraction and data transfer from the Clinical Practice Research Datalink (CPRD) and the MarketScan databases. We will perform a systematic review of scientific and grey literature in order to identify published relevant studies (epidemiological and clinical), clinical and administrative databases and projects related to human infections caused by target antimicrobial resistant pathogens.
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In addition, we will consider potential inputs from e.g. the GRAM project (sponsored by a.o.FlemingFund, Wellcome Trust), BARNARDS(Bill and Melinda Gatesfoundation), ACORN (Wellcome Trust), NeoOBS (GARDP), ATLAS (Pfizer), SMART (Merck) and studies by the ARLG (CRACKLE, others).
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Objectives:
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Identify existing databases including relevant individual patients’ data on infections caused by antimicrobial-resistant bacteria which would be important for the model(s).
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Assess the accessibility to individual patient data and development of a data management and data validation plan.
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Development of an eCRF and other data management systems to facilitate and implement harmonized and standardized data extraction.
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Set up of an ethical charter for the future use of de-identified data.
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Develop a statistical analysis plan that allows providing the data needed to feed the model.
Academic Lead: Prof. Jesús Rodríguez Baño, SAS: Dr. Jesús Rodríguez-Baño is head of the Infectious Diseases division at Hospital Universitario Virgen Macarena, and a Professor of Medicine at the University of Seville. He is also Past-President of the European Society of Clinical Microbiology and Infectious Diseases. His main areas of interest in research are antimicrobial resistance, antimicrobial treatment, and healthcare-associated infections, in which he has experience in leading clinical trials and multi-centre cohort studies. He has published more than 350 articles in peer-reviewed journals and is associate-editor of Clinical Microbiology and Infection. His experience includes being work package leader or co-leader for a number of European consortium projects on antimicrobial resistance.
Industry Lead: Valerie Oriol Mathieu (Johnson & Johnson) is a Medical Doctor with a Master of strategic management and Vaccinology degrees. After a few years of clinical practice, she continued her career in contract research organizations, focusing on pharmacovigilance, clinical development and post-approval studies. Since 2006, she specialized in infectious diseases and vaccines through various positions in the vaccine industry especially in Medical Affairs and Policy. Currently, Valerie Oriol Mathieu is Head Scientific Affairs, Communicable Diseases at J&J Innovative Medicine. She is member of the compound development team of the ExPEC vaccine with responsibilities including evidence generation and publications.