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VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe
J. Salmanton-García, P. Wipfler, P. Valle-Simón, C. Merakou, I. Kopsidas, U. Bethe, A. Steinbach, O. Spivak, L. Součková, MA. Mendonça, M. Koniordou, M. Hellemans, J. Frías-Iniesta, RJ. Davis, I. Barta, AM. Azzini, HH. Askling, CD. Argyropoulos,...
Jazyk angličtina Země Nizozemsko
Typ dokumentu časopisecké články, práce podpořená grantem
NLK
ProQuest Central
od 2002-01-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health & Medicine (ProQuest)
od 2002-01-01 do Před 2 měsíci
Family Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Health Management Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
Public Health Database (ProQuest)
od 2002-01-01 do Před 2 měsíci
- MeSH
- COVID-19 * MeSH
- dítě MeSH
- dospělí MeSH
- lidé MeSH
- Orthomyxoviridae * MeSH
- SARS-CoV-2 MeSH
- vakcíny * MeSH
- Check Tag
- dítě MeSH
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. METHODS: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study characteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selection process. RESULTS: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. CONCLUSIONS: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe.
Biomedical Research Center of the Slovak Academy of Sciences Bratislava Slovakia
Centre of Excellence for Health Immunity and Infections Rigshospitalet Copenhagen Denmark
Centro Hospitalar Universitário do Porto Porto Portugal
Centro Nacional de Microbiologia Instituto de Salud Carlos 3 Madrid Spain
Collaborative Center for Clinical Epidemiology and Outcomes Research Athens Greece
Department of Infectious Diseases and Hepatology Medical University of Bialystok Białystok Poland
Department of Medical Microbiology University Medical Centre Utrecht Utrecht Netherlands
European University of Cyprus Nicosia Republic of Cyprus
German Centre for Infection Research Partner Site Bonn Cologne Cologne Germany
Haceteppe University Ankara Turkey
Hospital La Paz Institute for Health Research Madrid Spain
Karolinska University Hospital Stockholm Sweden
Masaryk University Brno Czech Republic
Medizinische Universität Wien Vienna Austria
Ministry of Health of Israel Jerusalem Israel
National Koranyi Institute for Pulmonology Budapest Hungary
Servicio Madrileño de Salud Madrid Spain
Universitaet Bern Bern Switzerland
University College Dublin National University of Ireland Dublin Ireland
University Medical Centre Utrecht Utrecht University Utrecht Netherlands
Citace poskytuje Crossref.org
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- $a Salmanton-García, Jon $u University of Cologne, Faculty of Medicine and University Hospital Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne, Cologne, Germany
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- $a VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe / $c J. Salmanton-García, P. Wipfler, P. Valle-Simón, C. Merakou, I. Kopsidas, U. Bethe, A. Steinbach, O. Spivak, L. Součková, MA. Mendonça, M. Koniordou, M. Hellemans, J. Frías-Iniesta, RJ. Davis, I. Barta, AM. Azzini, HH. Askling, CD. Argyropoulos, E. Álvarez-Barco, M. Akova, MMJ. Bonten, M. Cohen-Kandli, RJ. Cox, R. Flisiak, P. Husa, L. Jancoriene, A. Koscalova, O. Launay, J. Lundgren, P. Mallon, L. Marques, P. Nauclér, J. Ochando, ZD. Pana, E. Tacconelli, K. Tóth, S. Trelle, P. van Damme, TE. Zaoutis, M. Zeitlinger, K. Albus, FA. Stewart, SHI. Hofstraat, P. Bruijning-Verhagen, OA. Cornely, VACCELERATE Consortium. Electronic address: trialsites@vaccelerate.eu
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- $a BACKGROUND: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. METHODS: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study characteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selection process. RESULTS: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. CONCLUSIONS: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe.
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- $a Barta, Imre $u National Koranyi Institute for Pulmonology, Budapest, Hungary
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- $a Azzini, Anna Maria $u University of Verona, Infectious Diseases Division, Department of Diagnostic and Public Health, Verona, Italy
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- $a Askling, Helena H $u Karolinska University Hospital, Stockholm, Sweden
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- $a Argyropoulos, Christos D $u European University of Cyprus, Nicosia, Republic of Cyprus
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- $a Bonten, Marc M J $u Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, Netherlands; Department of Medical Microbiology, University Medical Centre Utrecht, Utrecht, Netherlands
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- $a Jancoriene, Ligita $u Institute of Clinical Medicine, Medical Faculty, Vilnius University, Vilnius University Hospital Santaros klinikos, Vilnius, Lithuania
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