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7 results on '"European Medicines Agency [London] (EMA)"'

1. Level of evidence for promising subgroup findings: The case of trends and multiple subgroups

Author

Steven Teerenstra, Julien Tanniou, Kit C.B. Roes, Sanne C. Smid, Ingeborg van der Tweel, CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, European Medicines Agency [London] (EMA), Julius Center for Health Sciences and Primary Care, University Medical Center [Utrecht], Department of Methodology and Statistic, Utrecht University [Utrecht], Medicines Evaluation Board [Utrecht], Radboud university [Nijmegen], Leerstoel Schoot, and Methodology and statistics for the behavioural and social sciences

Subjects
Statistics and Probability, medicine.medical_specialty, failed study, overall nonsignificant trial, Epidemiology, [SDV]Life Sciences [q-bio], Subgroup analysis, 01 natural sciences, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], 010104 statistics & probability, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, 0302 clinical medicine, Bias, Covariate, Outcome Assessment, Health Care, medicine, 030212 general & internal medicine, 0101 mathematics, subgroup analysis, ComputingMilieux_MISCELLANEOUS, clinical trials, Clinical Trials as Topic, type I error, business.industry, Mechanism (biology), multiple testing, Evidence-based medicine, Clinical trial, [STAT]Statistics [stat], Data Interpretation, Statistical, Multiple comparisons problem, business, Clinical psychology, Type I and type II errors
Abstract

Subgroup analyses are an essential part of fully understanding the complete results from confirmatory clinical trials. However, they come with substantial methodological challenges. In case no statistically significant overall treatment effect is found in a clinical trial, this does not necessarily indicate that no patients will benefit from treatment. Subgroup analyses could be conducted to investigate whether a treatment might still be beneficial for particular subgroups of patients. Assessment of the level of evidence associated with such subgroup findings is primordial as it may form the basis for performing a new clinical trial or even drawing the conclusion that a specific patient group could benefit from a new therapy. Previous research addressed the overall type I error and the power associated with a single subgroup finding for continuous outcomes and suitable replication strategies. The current study aims at investigating two scenarios as part of a nonconfirmatory strategy in a trial with dichotomous outcomes: (a) when a covariate of interest is represented by ordered subgroups, eg, in case of biomarkers, and thus, a trend can be studied that may reflect an underlying mechanism, and (b) when multiple covariates, and thus multiple subgroups, are investigated at the same time. Based on simulation studies, this paper assesses the credibility of subgroup findings in overall nonsignificant trials and provides practical recommendations for evaluating the strength of evidence of subgroup findings in these settings.

Published
2019
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2. The use of aminoglycosides in animals within the EU: development of resistance in animals and possible impact on human and animal health: a review

Author

Merja Rantala, Helen Jukes, Zoltan Kunsagi, Christopher Teale, Kristine Ignate, Engeline van Duijkeren, Keith E. Baptiste, Pascal Sanders, Miguel A. Moreno, Damien Bouchard, Constança Pomba, Boudewijn Catry, Astrid Louise Wester, Modestas Ružauskas, Christine Schwarz, National Institute for Public Health and the Environment [Bilthoven] (RIVM), Federal Office of Consumer Protection and Food Safety, Anses ANMV (Anses ANMV), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Sciensano [Bruxelles], Réseau International des Instituts Pasteur (RIIP), Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB), Universidade de Lisboa (ULISBOA), Danish Medicines Agency, Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), University of Helsinki, Lithuanian University of Health Sciences [Kaunas, Lithuania], Laboratoire de Fougères, Bâtiment Bioagropolis, Laboratoire de Fougères - ANSES, Animal and Plant Health Agency [Weybridge] (APHA), World Health Organisation (WHO), Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), European Medicines Agency [London] (EMA), VMD, and Department for Environment, Food and Rural Affairs (DEFRA)

Subjects
0301 basic medicine, Microbiology (medical), Salmonella, médicament vétérinaire, Livestock, antibiotic resistance, medicine.drug_class, 030106 microbiology, Antibiotics, Human pathogen, résistance aux antibiotiques, Drug resistance, veterinary drug, medicine.disease_cause, Microbiology, antibiotic use, Antimicrobial Stewardship, 03 medical and health sciences, Antibiotic resistance, Zoonoses, Drug Resistance, Bacterial, Escherichia coli, medicine, Animals, Humans, Pharmacology (medical), animal, human, Pharmacology, [SDV.BA.MVSA]Life Sciences [q-bio]/Animal biology/Veterinary medicine and animal Health, Bacteria, biology, Pseudomonas aeruginosa, Campylobacter, transmission, biology.organism_classification, utilisation, Anti-Bacterial Agents, 3. Good health, Europe, Aminoglycosides, 030104 developmental biology, Infectious Diseases, Enterococcus, Health, aminoglycoside, humain
Abstract

Aminoglycosides (AGs) are important antibacterial agents for the treatment of various infections in humans and animals. Following extensive use of AGs in humans, food-producing animals and companion animals, acquired resistance among human and animal pathogens and commensal bacteria has emerged. Acquired resistance occurs through several mechanisms, but enzymatic inactivation of AGs is the most common one. Resistance genes are often located on mobile genetic elements, facilitating their spread between different bacterial species and between animals and humans. AG resistance has been found in many different bacterial species, including those with zoonotic potential such as Salmonella spp., Campylobacter spp. and livestock-associated MRSA. The highest risk is anticipated from transfer of resistant enterococci or coliforms (Escherichia coli) since infections with these pathogens in humans would potentially be treated with AGs. There is evidence that the use of AGs in human and veterinary medicine is associated with the increased prevalence of resistance. The same resistance genes have been found in isolates from humans and animals. Evaluation of risk factors indicates that the probability of transmission of AG resistance from animals to humans through transfer of zoonotic or commensal foodborne bacteria and/or their mobile genetic elements can be regarded as high, although there are no quantitative data on the actual contribution of animals to AG resistance in human pathogens. Responsible use of AGs is of great importance in order to safeguard their clinical efficacy for human and veterinary medicine.

Published
2019
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3. Quality indicators for responsible antibiotic use in the inpatient setting: a systematic review followed by an international multidisciplinary consensus procedure

Author

Monnier, AA, Schouten, J, Le Maréchal, M, Tebano, G, Pulcini, C, Stanić Benić, M, Vlahović-Palĉevski, V, Milanič, R, Adriaenssens, N, Versporten, A, Huttner, B, Zanichelli, V, Hulscher, ME, Gyssens, IC, Antonisse, A, Beović, B, Borg, M, Buyle, F, Cavaleri, M, Dhillon, H, Dumartin, C, Drew, R, Findlay, D, Ghafur, A, Grayson, L, Hermsen, E, Hicks, L, Howard, P, Kenston, M, Kesselheim, AS, Knirsch, C, Lacor, P, Laxminarayan, R, Paul, M, Plachouras, D, Poulakou, G, Rabaud, C, Rex, JH, Rodriguez-Baño, J, Srinivasan, A, Lundborg, CS, Tängdén, T, Thamlikitkul, V, Waluszewski, A, Wellsteed, S, Wertheim, H, Wild, C, Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université de Lorraine (UL), Service des Maladies Infectieuses et Tropicales [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Department of Infectious Diseases and Infection Control [Geneva, Switzerland], Hôpitaux Universitaires de Genève (HUG), Scientific Center for Quality of Healthcare [Nijmegen, The Netherlands], Radboud University Medical Center [Nijmegen]-Radboud Institute for Health Sciences [Nijmegen, the Netherlands], University Medical Center Ljubljana, European Medicines Agency [London] (EMA), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Center for Disease Dynamics, Economics & Policy (CDDEP), Sackler Faculty of Medicine, Tel Aviv University [Tel Aviv], Fourth Department of Medicine, University Hospital Virgen Macarena, Department of Economic History, Uppsala University, Oxford University Clinical Research Unit [Ho Chi Minh City] (OUCRU), Radboud University Medical Center [Nijmegen], Hasselt University (UHasselt), University Hospital Rijeka, University of Rijeka, Vaccine & Infectious Disease Institute [Antwerp, Belgium] (VAXINFECTIO), University of Antwerp (UA), Geneva University Hospitals and Geneva University, DRIVE-AB WP1 Grp, and APH - Aging & Later Life

Subjects
0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Internationality, Delphi Technique, intrinsic drive, 030106 microbiology, lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], BIOMEDICINE AND HEALTHCARE. Basic Medical Sciences. Pharmacology, Medical Records, antibiotics, inpatients, Antimicrobial Stewardship, 03 medical and health sciences, Stakeholder Participation, Surveys and Questionnaires, Antimicrobial chemotherapy, medicine, Humans, Pharmacology (medical), guidelines, Antibiotic use, internet, quality indicators, public health medicine, community, consensus, Intensive care medicine, Biology, ComputingMilieux_MISCELLANEOUS, Quality Indicators, Health Care, Pharmacology, ddc:616, Internet, business.industry, Pharmacology. Therapy, BIOMEDICINA I ZDRAVSTVO. Temeljne medicinske znanosti. Farmakologija, Anti-Bacterial Agents, 3. Good health, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Infectious Diseases, Supplement Papers, Practice Guidelines as Topic, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Public Health, Human medicine, business
Abstract

Contains fulltext : 193452.pdf (Publisher’s version ) (Open Access) Background: This study was conducted as part of the Driving Reinvestment in Research and Development and Responsible Antibiotic Use (DRIVE-AB) project and aimed to develop generic quality indicators (QIs) for responsible antibiotic use in the inpatient setting. Methods: A RAND-modified Delphi method was applied. First, QIs were identified by a systematic review. A complementary search was performed on web sites of relevant organizations. Duplicates were removed and disease and patient-specific QIs were combined into generic indicators. The relevance of these QIs was appraised by a multidisciplinary international stakeholder panel through two questionnaires and an in-between consensus meeting. Results: The systematic review retrieved 70 potential generic QIs. The QIs were appraised by 25 international stakeholders with diverse backgrounds (medical community, public health, patients, antibiotic research and development, regulators, governments). Ultimately, 51 QIs were selected in consensus. QIs with the highest relevance score included: (i) an antibiotic plan should be documented in the medical record at the start of the antibiotic treatment; (ii) the results of bacteriological susceptibility testing should be documented in the medical record; (iii) the local guidelines should correspond to the national guidelines but should be adapted based on local resistance patterns; (iv) an antibiotic stewardship programme should be in place at the healthcare facility; and (v) allergy status should be taken into account when antibiotics are prescribed. Conclusions: This systematic and stepwise method combining evidence from literature and stakeholder opinion led to multidisciplinary international consensus on generic inpatient QIs that can be used globally to assess the quality of antibiotic use.

Published
2018
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4. Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health

Author

Karolina Törneke, Merja Rantala, Anja Holm, David Mackay, Jordi Torren Edo, Engeline van Duijkeren, Ernesto Liebana, Kornelia Grein, Cristina Muñoz Madero, Helen Jukes, Satu Pyörälä, Kari Grave, Keith E. Baptiste, Antonio López Navas, Anna-Pelagia Magiorakos, Miguel Angel Moreno Romo, Eric John Threlfall, Mair Powell, Marco Cavaleri, Boudewijn Catry, Pascal Sanders, Gérard Moulin, Maria Constança Matias Ferreira Pomba, Modestas Ružauskas, Christopher Teale, Institut Scientifique de Santé Publique [Belgique] - Scientific Institute of Public Health [Belgium] (WIV-ISP), Réseau International des Instituts Pasteur (RIIP), European Medicines Agency [London] (EMA), Danish Health and Medicines Agency, European Food Safety Authority = Autorité européenne de sécurité des aliments, European Centre for Disease Prevention and Control (ECDC), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), Anses ANMV (Anses ANMV), Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), Université de Lisbonne, and University of Helsinki

Subjects
Acinetobacter baumannii, antibiotic resistance, Polymyxin, Antibiotics, colistine, résistance aux antibiotiques, medicine.disease_cause, polycyclic compounds, Pharmacology (medical), media_common, 0303 health sciences, biology, Bacterial Infections, General Medicine, Antimicrobial, Anti-Bacterial Agents, 3. Good health, Europe, Infectious Diseases, Pseudomonas aeruginosa, lipids (amino acids, peptides, and proteins), medicine.drug, Microbiology (medical), medicine.medical_specialty, medicine.drug_class, Chemoprevention, Microbiology, 03 medical and health sciences, Antibiotic resistance, [SDV.SP.MED]Life Sciences [q-bio]/Pharmaceutical sciences/Medication, Enterobacteriaceae, Drug Resistance, Bacterial, medicine, Animals, Humans, media_common.cataloged_instance, European Union, European union, Intensive care medicine, 030304 developmental biology, [SDV.BA.MVSA]Life Sciences [q-bio]/Animal biology/Veterinary medicine and animal Health, Colistin, 030306 microbiology, biochemical phenomena, metabolism, and nutrition, bacterial infections and mycoses, biology.organism_classification, bacteria
Abstract

International audience; Since its introduction in the 1950s, colistin has been used mainly as a topical treatment in human medicine owing to its toxicity when given systemically. Sixty years later, colistin is being used as a last-resort drug to treat infections caused by multidrug-resistant (MDR) Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae (e.g., Escherichia coli, Klebsiella pneumoniae), for which mortality can be high. In veterinary medicine, colistin has been used for decades for the treatment and prevention of infectious diseases. Colistin has been administered frequently as a group treatment for animal gastrointestinal infections caused by Gram-negative bacteria within intensive husbandry systems. Given the ever-growing need to retain the efficacy of antimicrobials used to treat MDR infections in humans, the use of colistin in veterinary medicine is being re-evaluated. Despite extensive use in veterinary medicine, there is limited evidence for the development of resistance to colistin and no evidence has been found for the transmission of resistance in bacteria that have been spread from animals to humans. Since surveillance for colistin resistance in animals is limited and the potential for such transmission exists, there is a clear need to reinforce systematic monitoring of bacteria from food-producing animals for resistance to colistin (polymyxins). Furthermore, colistin should only be used for treatment of clinically affected animals and no longer for prophylaxis of diseases, in line with current principles of responsible use of antibiotics.

Published
2015
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5. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis

Author

Angelo Pan, Sumanth Gandra, Elena Carrara, Souha S. Kanj, Karin Leder, Yang Soo Kim, Ana Cristina Gales, Christopher R. Houchens, Babacar Ndoye, Haibo Qiu, Lynn L. Silver, Jesús Rodríguez-Baño, Jasper Littman, David L. Paterson, Oliver J. Dyar, Paul Hansen, Mical Paul, Neil Woodford, Pilar Ramon-Pardo, Marie-Paule Kieny, Nalini Singh, Massinissa Si-Mehand, Wonkeung Song, Fidan O Yilmaz, Thomas Gottlieb, Jean B. Patel, Aaron O. Aboderin, Nguyen Van Kinh, Marc Mendelson, Seif Al-Abri, Manuel Guzman Blanco, Agnes Wechsler-Fördös, Waleria Hryniewicz, Vikas Manchanda, Timothy Jinks, Evelyn Wesangula, Gunnar Kahlmeter, Nicola Magrini, Otto Cars, Mike Sharland, Lawrence Kerr, Jaime Labarca, Debra A. Goff, Ursula Theuretzbacher, Francesco Robert Burkert, Gabriel Levy-Hara, Deepthi Kattula, Jan Kluytmans, Edward Cox, Jens Thomsen, Surbhi Malhotra-Kumar, Alexander W. Friedrich, Marco Cavaleri, Nordiah Awang Jalil, Maria Virginia Villegas, Roman S. Kozlov, Guy E. Thwaites, Kevin Outterson, Leonard Leibovici, Jos W. M. van der Meer, Stéphan Juergen Harbarth, Silvio Vega, Yehuda Carmeli, Dominique L Monnet, Lorenzo Moja, Heiman F. L. Wertheim, Martin Steinbakk, Giuseppe Cornaglia, Ramanan Laxminarayan, Maurizio Sanguinetti, Adrian Brink, Nur Benzonana, Sanjay Bhattacharya, Anna Zorzet, Alessia Savoldi, Céline Pulcini, Christian G. Giske, Herman Goossens, Evelina Tacconelli, M Lindsay Grayson, Sharmila Sengupta, Marc Ouellette, University Hospital Tübingen, University Hospital of Verona, Geneva University Hospital (HUG), University of Cape Town, European Centre for Disease Prevention and Control (ECDC), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université de Lorraine (UL), Växjö Hospital, Laboratory for Microbiology and Infection Control, Amphia Hospital, University Medical Center [Utrecht], Université Laval [Québec] (ULaval), Boston University [Boston] (BU), Centers for Disease Control and Prevention [Atlanta] (CDC), Centers for Disease Control and Prevention, European Medicines Agency [London] (EMA), U.S. Food and Drug Administration (FDA), University of Melbourne, University of Otago [Dunedin, Nouvelle-Zélande], The George Washington University (GW), Center for Anti-Infective Agents, World Health Organization [Geneva], and WHO Pathogens Priority List Working Group

Subjects
0301 basic medicine, Tuberculosis, medicine.drug_class, 030106 microbiology, Antibiotics, lnfectious Diseases and Global Health Radboud Institute for Molecular Life Sciences [Radboudumc 4], Drug resistance, World Health Organization, medicine.disease_cause, Settore MED/07 - MICROBIOLOGIA E MICROBIOLOGIA CLINICA, WHO, 03 medical and health sciences, Antibiotic resistance, All institutes and research themes of the Radboud University Medical Center, Environmental health, Drug Resistance, Bacterial, medicine, Humans, Biology, WHO, antibiotic-resistant bacteria, tuberculosis, ddc:616, antibiotic-resistant bacteria, biology, business.industry, Campylobacter, medicine.disease, biology.organism_classification, Anti-Bacterial Agents, 3. Good health, Acinetobacter baumannii, Infectious Diseases, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], tuberculosis, N/A, Neisseria gonorrhoeae, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Human medicine, business, Enterococcus faecium
Abstract

Summary Background The spread of antibiotic-resistant bacteria poses a substantial threat to morbidity and mortality worldwide. Due to its large public health and societal implications, multidrug-resistant tuberculosis has been long regarded by WHO as a global priority for investment in new drugs. In 2016, WHO was requested by member states to create a priority list of other antibiotic-resistant bacteria to support research and development of effective drugs. Methods We used a multicriteria decision analysis method to prioritise antibiotic-resistant bacteria; this method involved the identification of relevant criteria to assess priority against which each antibiotic-resistant bacterium was rated. The final priority ranking of the antibiotic-resistant bacteria was established after a preference-based survey was used to obtain expert weighting of criteria. Findings We selected 20 bacterial species with 25 patterns of acquired resistance and ten criteria to assess priority: mortality, health-care burden, community burden, prevalence of resistance, 10-year trend of resistance, transmissibility, preventability in the community setting, preventability in the health-care setting, treatability, and pipeline. We stratified the priority list into three tiers (critical, high, and medium priority), using the 33rd percentile of the bacterium's total scores as the cutoff. Critical-priority bacteria included carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa , and carbapenem-resistant and third-generation cephalosporin-resistant Enterobacteriaceae. The highest ranked Gram-positive bacteria (high priority) were vancomycin-resistant Enterococcus faecium and meticillin-resistant Staphylococcus aureus . Of the bacteria typically responsible for community-acquired infections, clarithromycin-resistant Helicobacter pylori , and fluoroquinolone-resistant Campylobacter spp, Neisseria gonorrhoeae , and Salmonella typhi were included in the high-priority tier. Interpretation Future development strategies should focus on antibiotics that are active against multidrug-resistant tuberculosis and Gram-negative bacteria. The global strategy should include antibiotic-resistant bacteria responsible for community-acquired infections such as Salmonella spp, Campylobacter spp, N gonorrhoeae , and H pylori . Funding World Health Organization.

Published
2018
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6. Fostering Responsible Research with Genome Editing Technologies: a European Perspective

Author

Mylene Botbol-Baum, Marion Abecassis, Johannes Rath, Ewa Bartnik, François Hirsch, Agnes Saint-Raymond, Albrecht M. Müller, Jennifer Merchant, Hervé Chneiweiss, Mihalis Kritikos, Bernard Baertschi, Ana Sofia Carvalho, Christiane Druml, James A. Houghton, Solveig Fenet, Lluis Montoliu, Bärbel Friedrich, Dirk Lanzerath, Janet Mifsud, Plasticité gliale et neuro-oncologie = Glial Plasticity (NPS-04), Neurosciences Paris Seine (NPS), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut de Biologie Paris Seine (IBPS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut de Biologie Paris Seine (IBPS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), INSERM Ethics Committee [Paris], Department of Microbiologie [Berlin, Germany], Humboldt-Universität zu Berlin, Pôle Langues [Panthéon-Assas, Paris], Université Panthéon-Assas (UP2), Institute for Biomedical Ethics [Geneva, Switzerland], University of Geneva Medical School, Institut de recherche santé et société [Louvain, Belgium] (IRSS), Université Catholique de Louvain = Catholic University of Louvain (UCL), Cytogenetics Unit [Galway, Ireland], National University of Ireland [Galway] (NUI Galway), Research Group on Law, Science, Technology and Society [Ixelles, Belgique] (LSTS), Vrije Universiteit Brussel (VUB), Department of Biology [Msida, Malta] (Faculty of Science), University of Malta [Malta], Institute of Genetics and Biotechnology [Warsaw, Poland] (Faculty of Biology), University of Warsaw (UW), Department of Integrative Zoology [Vienna, Austria], University of Vienna [Vienna], UNESCO Chair on Bioethics [Vienna, Austria], Medizinische Universität Wien = Medical University of Vienna, German National Academy of Sciences Leopoldina [Halle, Germany], Instituto de Bioética, and Portuguese National Council for Ethics in Life Sciences [Porto, Portugal], Universidade Católica Portuguesa, European Research Ethics Committee Network [Ixelles, Belgium] (EUREC), Human Medicines Development and Evaluation [London, UK], European Medicines Agency [London] (EMA), Veritati - Repositório Institucional da Universidade Católica Portuguesa, UCL - SSS/IRSS - Institut de recherche santé et société, Chneiweiss, Hervé, Neuroscience Paris Seine (NPS), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut de Biologie Paris Seine (IBPS), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Humboldt University Of Berlin, Centre National de la Recherche Scientifique (CNRS)-Institut de Biologie Paris Seine (IBPS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut de Biologie Paris Seine (IBPS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), Humboldt Universität zu Berlin, Université Catholique de Louvain (UCL), and Vrije Universiteit [Brussels] (VUB)

Subjects
0301 basic medicine, Steering committee, [SDV]Life Sciences [q-bio], Research -- Moral and ethical aspects, responsible research and innovation, Legislation, [SDV.GEN] Life Sciences [q-bio]/Genetics, Gene editing, Biology, Bioinformatics, Responsible research and innovation, 03 medical and health sciences, 0302 clinical medicine, Genome editing, Genetics, Humans, 030212 general & internal medicine, CRISPR-Cas, Letter to the Editor, ComputingMilieux_MISCELLANEOUS, Science and society, [SDV.IB] Life Sciences [q-bio]/Bioengineering, [SDV.GEN]Life Sciences [q-bio]/Genetics, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Responsible Research and Innovation, business.industry, gene editing, Perspective (graphical), Genetic engineering -- Law and legislation, Public relations, science and society, [SDV.ETH] Life Sciences [q-bio]/Ethics, Expert group, [SDV.ETH]Life Sciences [q-bio]/Ethics, Europe, [SDV] Life Sciences [q-bio], 030104 developmental biology, Science -- Social aspects, Animal Science and Zoology, [SDV.IB]Life Sciences [q-bio]/Bioengineering, CRISPR-Cas Systems, business, Agronomy and Crop Science, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Biotechnology
Abstract

In this consensus paper resulting from a meeting that involved representatives from more than 20 European partners, we recommend the foundation of an expert group (European Steering Committee) to assess the potential benefits and draw-backs of genome editing (off-targets, mosaicisms, etc.), and to design risk matrices and scenarios for a responsible use of this promising technology. In addition, this European steering committee will contribute in promoting an open debate on societal aspects prior to a translation into national and international legislation., peer-reviewed

Published
2017
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7. Identification and validation of biomarkers for autism spectrum disorders

Author

Marion Haberkamp, Karl Broich, Sarah Durston, Antonio M. Persico, Luca Pani, Tony Charman, Michael V. Lombardo, Luke Mason, Sven Bölte, Declan G. Murphy, Christine Ecker, Simon Baron-Cohen, Koichi Okamoto, Emily J.H. Jones, Jordi Llinares-Garcia, Steve C.R. Williams, Lindsay Ham, Will Spooren, Spiros Vamvakas, David A. Collier, Emily Simonoff, Caroline Auriche-Benichou, Maria Isaac, Thomas Bourgeron, Valentina Mantua, Sabine Lenton, Andreas Meyer-Lindenberg, Robert Hemmings, Sitra Tauscher-Wisniewski, Mark H. Johnson, Eva Loth, Jan K. Buitelaar, Omar Khwaja, Andre Elferink, Gahan Pandina, Tobias Banaschewski, Laurence O'Dwyer, Fernando de Andres-Trelles, Institute of Psychiatry, Psychology & Neuroscience, King's College London, King‘s College London, Roche Pharma Research and Early Development [Basel] (pRED), F. Hoffmann-La Roche [Basel], European Medicines Agency [London] (EMA), Agence nationale de sécurité du médicament et des produits de santé [Saint-Denis] (ANSM), Medizinische Fakultät Mannheim, Universität Heidelberg [Heidelberg] = Heidelberg University, University of Cambridge [UK] (CAM), Federal Institute of Drugs and Medical Devices [Bonn], Karolinska Institutet [Stockholm], Génétique humaine et fonctions cognitives - Human Genetics and Cognitive Functions (GHFC (UMR_3571 / U-Pasteur_1)), Institut Pasteur [Paris] (IP)-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Eli Lilly and Company Limited [Windlesham], Spanish Medicines Agency and Medical Devices [Madrid] (AEMPS), University Medical Center [Utrecht], Medicines Evaluation Board [Utrecht], Centre for Brain and Cognitive Development [Birkbeck College], Birkbeck College [University of London], Italian Medicines Agency [Roma] (AIFA), University of Cyprus [Nicosia] (UCY), Radboud University Medical Center [Nijmegen], Janssen Research & Development, Università Campus Bio-Medico di Roma / University Campus Bio-Medico of Rome ( UCBM), Universität Heidelberg [Heidelberg], Institut Pasteur [Paris]-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), and University of Cyprus [Nicosia]

Subjects
Male, Autism Spectrum Disorder, [SDV]Life Sciences [q-bio], [SCCO]Cognitive science, 0302 clinical medicine, MESH: Child, Drug Discovery, Child, ComputingMilieux_MISCELLANEOUS, MESH: Autism Spectrum Disorder, Medicine (all), 05 social sciences, MESH: Endophenotypes, General Medicine, Autism spectrum disorders, Gene expression profiling, MESH: Reproducibility of Results, Autism spectrum disorder, MESH: Young Adult, Child, Preschool, Female, Identification (biology), 050104 developmental & child psychology, Adult, medicine.medical_specialty, Adolescent, Endophenotypes, Brain imaging, Computational biology, Young Adult, 03 medical and health sciences, Neuroimaging, medicine, Humans, 0501 psychology and cognitive sciences, Preschool, Psychiatry, Pharmacology, MESH: Adolescent, [SDV.GEN]Life Sciences [q-bio]/Genetics, MESH: Humans, Neurodevelopmental disorders Donders Center for Medical Neuroscience [Radboudumc 7], business.industry, Drug Discovery3003 Pharmaceutical Science, MESH: Child, Preschool, Reproducibility of Results, MESH: Adult, medicine.disease, MESH: Male, Adolescent, Adult, Autism Spectrum Disorder, Biomarkers, Child, Child, Preschool, Endophenotypes, Female, Humans, Male, Reproducibility of Results, Young Adult, Medicine (all), Pharmacology, Drug Discovery3003 Pharmaceutical Science, Biomarkers, Endophenotype, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, MESH: Biomarkers, Autism, business, MESH: Female, 030217 neurology & neurosurgery
Abstract

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2015
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