The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
Viktor Varant - One of the best experts on this subject based on the ideXlab platform.
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The RISKSUR EVA tool (Survtool): A tool for the integrated Evaluation of animal health surveillance systems
Preventive Veterinary Medicine, 2019Co-Authors: Marisa Peyre, Linda Hoinville, James Njoroge, Angus Cameron, Daniel Traon, Flavie Goutard, Clementine Calba, Vladimir Grosbois, Alexis Delabouglise, Viktor VarantAbstract:Information about infectious diseases at the global level relies on effective, efficient and sustainable national and international surveillance systems. Surveillance systems need to be regularly evaluated to ensure their performance, the quality of the data and information provided, as well as to allocate resources efficiently. Currently available frameworks for Evaluation of surveillance systems in animal or human health often treat technical, process and socio-economic aspects separately instead of integrating them. The surveillance Evaluation (EVA) tool, a support tool for the Evaluation of animal health surveillance systems, was developed to provide guidance for integrated Evaluation of animal health surveillance including economic Evaluation. The tool was developed by international experts in surveillance and Evaluation in an iterative process of development, testing and revision taking into account existing frameworks and guidance, scientific literature and expert opinion. The EVA tool encompasses a web interface for users to develop an Evaluation Plan, a Wiki classroom to provide theoretical information on all required concepts and a generic Evaluation work Plan to facilitate implementation and reporting of outputs to decision makers. The tool was tested by Planning and conducting epidemiological and economic Evaluations of surveillance for classical and African swine fever, bovine virus diarrhoea, avian influenza, and Salmonella Dublin in five European countries. These practical applications highlighted the importance of a comprehensive Evaluation approach to improve the quality of the Evaluation outputs (economic Evaluation; multiple attributes assessment) and demonstrated the usefulness of the guidance provided by the EVA tool. At the same time they showed that comprehensive Evaluations might be constrained by practical issues (e.g. confidentiality concerns, data availability) and resource scarcity. In the long term, the EVA tool is expected to increase professional Evaluation capacity and help optimising animal health surveillance system efficiency and resource allocation for both public and private actors of the surveillance systems.
Robert A. Byrne - One of the best experts on this subject based on the ideXlab platform.
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report of an esc eapci task force on the Evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention executive summary
Eurointervention, 2018Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Giulio G Stefanini, Davide Capodanno, Yoshinobu Onuma, Michael Haude, Peter JuniAbstract:A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the nonclinical and clinical Evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device - the Absorb bioresorbable vascular scaffold - has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to Evaluation in clinical studies. A clinical Evaluation Plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved Plan for a large-scale randomized clinical trial with Planned long-term follow-up.
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report of a european society of cardiology european association of percutaneous cardiovascular interventions task force on the Evaluation of coronary stents in europe executive summary
European Heart Journal, 2015Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Jean Fajadet, Patrick W Serruys, Peter Juni, Semih Oktay, Adnan KastratiAbstract:The Evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the Evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical Evaluation pathway for market approval. The two-stage clinical Evaluation Plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint Evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
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report of a european society of cardiology european association of percutaneous cardiovascular interventions task force on the Evaluation of coronary stents in europe executive summary
European Heart Journal, 2015Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Jean Fajadet, Patrick W Serruys, Peter Juni, Semih Oktay, Adnan KastratiAbstract:The Evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the Evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical Evaluation pathway for market approval. The two-stage clinical Evaluation Plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint Evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
Adnan Kastrati - One of the best experts on this subject based on the ideXlab platform.
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report of a european society of cardiology european association of percutaneous cardiovascular interventions task force on the Evaluation of coronary stents in europe executive summary
European Heart Journal, 2015Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Jean Fajadet, Patrick W Serruys, Peter Juni, Semih Oktay, Adnan KastratiAbstract:The Evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the Evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical Evaluation pathway for market approval. The two-stage clinical Evaluation Plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint Evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
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report of a european society of cardiology european association of percutaneous cardiovascular interventions task force on the Evaluation of coronary stents in europe executive summary
European Heart Journal, 2015Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Jean Fajadet, Patrick W Serruys, Peter Juni, Semih Oktay, Adnan KastratiAbstract:The Evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the Evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical Evaluation pathway for market approval. The two-stage clinical Evaluation Plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint Evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
Peter Juni - One of the best experts on this subject based on the ideXlab platform.
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report of an esc eapci task force on the Evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention executive summary
Eurointervention, 2018Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Giulio G Stefanini, Davide Capodanno, Yoshinobu Onuma, Michael Haude, Peter JuniAbstract:A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the nonclinical and clinical Evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device - the Absorb bioresorbable vascular scaffold - has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to Evaluation in clinical studies. A clinical Evaluation Plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved Plan for a large-scale randomized clinical trial with Planned long-term follow-up.
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report of a european society of cardiology european association of percutaneous cardiovascular interventions task force on the Evaluation of coronary stents in europe executive summary
European Heart Journal, 2015Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Jean Fajadet, Patrick W Serruys, Peter Juni, Semih Oktay, Adnan KastratiAbstract:The Evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the Evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical Evaluation pathway for market approval. The two-stage clinical Evaluation Plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint Evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
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report of a european society of cardiology european association of percutaneous cardiovascular interventions task force on the Evaluation of coronary stents in europe executive summary
European Heart Journal, 2015Co-Authors: Robert A. Byrne, Michael Joner, Stefan James, Javier Escaned, Andreas Baumbach, Jean Fajadet, Patrick W Serruys, Peter Juni, Semih Oktay, Adnan KastratiAbstract:The Evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the Evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical Evaluation pathway for market approval. The two-stage clinical Evaluation Plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint Evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
Patrick Kenny - One of the best experts on this subject based on the ideXlab platform.
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a joint factor analysis approach to progressive model adaptation in text independent speaker verification
IEEE Transactions on Audio Speech and Language Processing, 2007Co-Authors: Shouchun Yin, Richard Rose, Patrick KennyAbstract:This paper addresses the issue of speaker variability and session variability in text-independent Gaussian mixture model (GMM)-based speaker verification. A speaker model adaptation procedure is proposed which is based on a joint factor analysis approach to speaker verification. It is shown in this paper that this approach facilitates the implementation of a progressive unsupervised adaptation strategy which is able to produce an improved model of speaker identity while minimizing the influence of channel variability. The paper also deals with the interaction between this model adaptation approach and score normalization strategies which act to reduce the variation in likelihood ratio scores. This issue is particularly important in establishing decision thresholds in practical speaker verification systems since the variability of likelihood ratio scores can increase as a result of progressive model adaptation. These adaptation methods have been evaluated under the adaptation paradigm defined under the NIST 2005 Speaker Recognition Evaluation Plan, which is based on conversation sides derived from telephone speech utterances. It was found that when target speaker models were trained from a single conversation, an equal error rate (EER) of 4.5% was obtained under the NIST unsupervised speaker adaptation scenario.
