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2. How the new European data protection regulation affects clinical research and recommendations?

Author

Bertoye, Pierre-Henri, Boidin, Romain, Bureau, Serge, Chrétien, Jean-Marie, Delval, Cécile, Deplanque, Dominique, Dubray, Claude, Duchossoy, Luc, Edel, Valérie, Fouret, Cécile, Galaup, Ariane, Lesaulnier, Frédérique, Matei, Mihaela, Naudet, Florian, Plattner, Valérie, Rubio, Michel, Ruiz, Fabrice, Sénéchal-Cohen, Sophie, Simon, Tabassome, Vidal, Anne, Viola, Anne, Violleau, Mireille, Demotes-Mainard, Jacques, Cornu, Catherine, and Guérin, Aurélie

Published
2019
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3. Quel impact du nouveau règlement européen sur la protection des données sur la recherche clinique et recommandations

Author

Bertoye, Pierre-Henri, Boidin, Romain, Bureau, Serge, Chrétien, Jean-Marie, Delval, Cécile, Deplanque, Dominique, Dubray, Claude, Duchossoy, Luc, Edel, Valérie, Fouret, Cécile, Galaup, Ariane, Lesaulnier, Frédérique, Matei, Mihaela, Naudet, Florian, Plattner, Valérie, Rubio, Michel, Ruiz, Fabrice, Sénéchal-Cohen, Sophie, Simon, Tabassome, Vidal, Anne, Viola, Anne, Violleau, Mireille, Demotes-Mainard, Jacques, Cornu, Catherine, and Guérin, Aurélie

Published
2019
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4. Mental health research priorities for Europe

Author

Wykes, Til, Haro, Josep Maria, Belli, Stefano R, Obradors-Tarragó, Carla, Arango, Celso, Ayuso-Mateos, José Luis, Bitter, István, Brunn, Matthias, Chevreul, Karine, Demotes-Mainard, Jacques, Elfeddali, Iman, Evans-Lacko, Sara, Fiorillo, Andrea, Forsman, Anna K, Hazo, Jean-Baptiste, Kuepper, Rebecca, Knappe, Susanne, Leboyer, Marion, Lewis, Shôn W, Linszen, Donald, Luciano, Mario, Maj, Mario, McDaid, David, Miret, Marta, Papp, Szilvia, Park, A-La, Schumann, Gunter, Thornicroft, Graham, van der Feltz-Cornelis, Christina, van Os, Jim, Wahlbeck, Kristian, Walker-Tilley, Tom, and Wittchen, Hans-Ulrich

Published
2015
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6. HealthyCloud Strategic Agenda for the Health Research Innovation Cloud (HRIC) - First Draft

Author

Canham, Steve, Ohman, Christian, Demotes-Mainard, Jacques, Panagiotopoulou, Maria, Matei, Mihaela, Blomberg, Niklas, Merchant, Arshiya, Chatterjee, Anamika, Saunders, Gary, González-García, Juan, Bernal-Delgado, Enrique, García-Armesto, Sandra, Portell-Silva, Laura, Capella-Gutiérrez, Salvador, Valencia, Alfonso, Jene-Sanz, Alba, Lopez-Cuesta, Lidia, Thorogood, Adrian, Becker, Regina, Satagopam, Venkata, Gu, Wei, Schluender, Irene, Holub, Petr, Mayrhofer, Michaela Th., Garcia-Alvarez, Eva, Kessissoglou, Irene, Schutte, Nienke, Cosgrove, Shona, Martínez-García, Alicia, C. Alvarez Romero, Parra-Calderón, Carlos Luis, Barysch, Sina, Lekadir, Karim, D'Altri, Teresa, Wagener, Harald, Martínez-Martínez, Ricard, Dietrich, Mark, and Sipos, Gergely

Subjects
health data, distributed computing, FAIR data
Abstract

This document is the first draft of the Strategic Agenda to towards the construction of the Health Research and Innovation Cloud (HRIC). The HRIC is intended to be one of the cornerstones of European Health Data Space, specifically on its incarnation devoted to secondary use of health data, building on top of existing initiatives such as the European Open Science Cloud (EOSC) building blocks. NOTE:thisdraft has not been approved by the European Commision and reflects only the opinions of the HealthyCloud Consortium.

Published
2022
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7. Ecrin: Needed in European science

Author

Marković Srđan Z., Kastratović Dragana A., Kubiak Christine, and Demotes Mainard Jacques

Subjects
ECRIN, ERIC, SMS, academic clinical trials, EUCOS, Therapeutics. Pharmacology, RM1-950
Abstract

Topic explanation: Modern trends of development in the field of applied science show that the investigator initiated clinical trials are very reliable way of developing and achieving a better quality of health services in all aspects of the organization of health systems. Presenting the topic position to scientific/professional public: ECRIN scientific partner for Serbia is Serbian Medical Society. The three medical areas supported in this project (rare diseases, medical devices, and nutrition) will serve as pilots for other biomedical research fields. For Serbia, the advantages of participating in ECRIN are: a structuring effect on the national clinical research community and infrastructure; a connection to the European infrastructure; allowing projects initiated in Serbian Medical Institutions via SMS to be run throughout the Europe and allowing projects initiated in any European country to be run in Serbia. Conclusion: Permanent cooperation through ECRIN ERIC SMS is a position that enables younger doctors of Serbia the development of science teams in Europe and the world. Time will show whether we will succeed through ECRIN to apply medical knowledge of XXI century.

Published
2015
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8. La médecine personnalisée : comment passer du concept à l’intégration dans un plan de développement clinique en vue d’une AMM ?

Author

Bardou, Marc, Beaune, Philippe, Belorgey, Chantal, Bibeau, Frédéric, Boissel, Jean-Pierre, Courcier, Soizic, De Broucker, Frédérique, Demotes-Mainard, Jacques, Diaz, Isabelle, Fagon, Jean-Yves, Girault, Danièle, Goni, Sylvia, Hanf, Rémy, Hermann, Marie-Annick, Mismetti, Patrick, Morali, Monique, Pavlovic, Mira, Perrin, Elena, Plétan, Yannick, Sauce, Christophe, Vassal, Gilles, Becquemont, Laurent, Bordet, Régis, and Cellier, Dominic

Published
2012
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9. Personalized Medicine: how to Switch from the Concept to the Integration into the Clinical Development Plan to Obtain Marketing Authorization

Author

Bardou, Marc, Beaune, Philippe, Belorgey, Chantal, Bibeau, Frédéric, Boissel, Jean-Pierre, Courcier, Soizic, De Broucker, Frédérique, Demotes-Mainard, Jacques, Diaz, Isabelle, Fagon, Jean-Yves, Girault, Danièle, Goni, Sylvia, Hanf, Rémy, Hermann, Marie-Annick, Mismetti, Patrick, Morali, Monique, Pavlovic, Mira, Perrin, Elena, Plétan, Yannick, Sauce, Christophe, Vassal, Gilles, Becquemont, Laurent, Bordet, Régis, and Cellier, Dominic

Published
2012
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12. Clinical Trials Legislation - Preparing for the Revision of the European Directive Scheduled for 2011

Author

Abiteboul, Michel, Bertram, Delphine, Cornu, Catherine, Chassany, Olivier, Demotes-Mainard, Jacques, Demarez, Jean-Paul, Diebolt, Vincent, Dubray, Claude, Ericson, Mats, Orvoen, Elisabeth Frija, Hirsch, François, Juillet, Yves, Lamarque, Véronique, Le Coent, Rémi, Libersa, Christian, Marey, Christine, Marchenay, Brigitte, Mijonnet, Armelle, Plattner, Valérie, Raison, Anne, Rossignol, Patrick, Rusch, Philippe, Simon, Tabassome, Bilbault, Pascal, Belorgey, Chantal, Zannad, Faiez, Golinelli, Danielle, and Pletan, Yannick

Published
2010
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13. Législation des essais cliniques : préparer la révision de la Directive Européenne prévue en 2011

Author

Abiteboul, Michel, Bertram, Delphine, Cornu, Catherine, Chassany, Olivier, Demotes-Mainard, Jacques, Demarez, Jean-Paul, Diebolt, Vincent, Dubray, Claude, Ericson, Mats, Orvoen, Elisabeth Frija, Hirsch, François, Juillet, Yves, Lamarque, Véronique, Le Coent, Rémi, Libersa, Christian, Marey, Christine, Marchenay, Brigitte, Mijonnet, Armelle, Plattner, Valérie, Raison, Anne, Rossignol, Patrick, Rusch, Philippe, Simon, Tabassome, Bilbault, Pascal, Belorgey, Chantal, Zannad, Faiez, Golinelli, Danielle, and Pletan, Yannick

Published
2010
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14. Methods for Stratification and Validation Cohorts: A Scoping Review

Author

Torres Moral, Teresa, Sanchez-Niubo, Albert, Monistrol-Mula, Anna, Gerardi, Chiara, Banzi, Rita, Garcia, Paula, Demotes-Mainard, Jacques, Haro, Josep Maria, The Permit Group, Imaz-Iglesia, Iñaki, and Unión Europea. Comisión Europea. H2020

Subjects
Sample size, Systematic reviews (Medical research), Medicine (miscellaneous), Medicina personalitzada, Stratification, Ressenyes sistemàtiques (Investigació mèdica), Personalized medicine, Cohorts
Abstract

Personalized medicine requires large cohorts for patient stratification and validation of patient clustering. However, standards and harmonized practices on the methods and tools to be used for the design and management of cohorts in personalized medicine remain to be defined. This study aims to describe the current state-of-the-art in this area. A scoping review was conducted searching in PubMed, EMBASE, Web of Science, Psycinfo and Cochrane Library for reviews about tools and methods related to cohorts used in personalized medicine. The search focused on cancer, stroke and Alzheimer's disease and was limited to reports in English, French, German, Italian and Spanish published from 2005 to April 2020. The screening process was reported through a PRISMA flowchart. Fifty reviews were included, mostly including information about how data were generated (25/50) and about tools used for data management and analysis (24/50). No direct information was found about the quality of data and the requirements to monitor associated clinical data. A scarcity of information and standards was found in specific areas such as sample size calculation. With this information, comprehensive guidelines could be developed in the future to improve the reproducibility and robustness in the design and management of cohorts in personalized medicine studies. This research was funded by the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 874825. Sí

Published
2022

15. ROAMER: roadmap for mental health research in Europe

Author

Haro, Josep Maria, Ayuso-Mateos, José Luis, Bitter, Istvan, Demotes-Mainard, Jacques, Leboyer, Marion, Lewis, Shôn W., Linszen, Donald, Maj, Mario, Mcdaid, David, Meyer-Lindenberg, Andreas, Robbins, Trevor W., Schumann, Gunter, Thornicroft, Graham, Van Der Feltz-Cornelis, Christina, Van Os, Jim, Wahlbeck, Kristian, Wittchen, Hans-Ulrich, Wykes, Til, Arango, Celso, Bickenbach, Jerome, Brunn, Matthias, Cammarata, Pamela, Chevreul, Karine, Evans-Lacko, Sara, Finocchiaro, Carla, Fiorillo, Andrea, Forsman, Anna K, Hazo, Jean-Baptiste, Knappe, Susanne, Kuepper, Rebecca, Luciano, Mario, Miret, Marta, Obradors-Tarragó, Carla, Pagano, Grazia, Papp, Szilvia, and Walker-Tilley, Tom

Published
2014
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20. Modèles de partenariats Public-Privé en France et en Europe

Author

Allain, H., Amédée-Manesme, O., Aymé, S., Boubekeur, K., Chabrier, P.-E., Clément, B., Collet, J.-P., Deregnaucourt, J., Habert Ortoli, E., Halioua, E., Hamelin, B., Juillet, Y., Lacombe, D., Lassale, C., Longuet, M., Pletan, Y., Vasmant, D., Vincent, C., Demotes-Mainard, Jacques, Canet, Emmanuel, and Segard, Lionel

Published
2006
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21. Public-Private Partnership Models in France and in Europe

Author

Allain, H., Amédée-Manesme, O., Aymé, S., Boubekeur, K., Chabrier, P.-E., Clément, B., Collet, J.-P., Deregnaucourt, J., Habert Ortoli, E., Halioua, E., Hamelin, B., Juillet, Y., Lacombe, D., Lassale, C., Longuet, M., Pletan, Y., Vasmant, D., Vincent, C., Demotes-Mainard, Jacques, Canet, Emmanuel, and Segard, Lionel

Published
2006
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24. What impact of the new European Data Protection Regulation on clinical research and recommendations

Author

Demotes-Mainard, Jacques, Cornu, Catherine, Guerin, Aurelie, Bertoye, Pierre-Henri, Boidin, Romain, Bureau, Serge, Chretien, Jean-Marie, Delval, Cecile, Deplanque, Dominique, Dubray, Claude, Duchossoy, Luc, Edel, Valerie, Fouret, Cecile, Galaup, Ariane, Lesaulnier, Frederique, Matei, Mihaela, Naudet, Florian, Plattner, Valerie, Rubio, Michel, Ruiz, Fabrice, Senechal-Cohen, Sophie, Simon, Tabassome, Vidal, Anne, Viola, Anne, Violleau, Mireille, European Clinical Research Infrastructures Network [Dusseldorf] (ECRIN), CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Pfizer, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Clermont-Ferrand, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Hospices Civils de Lyon (HCL), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Recherche clinique, Big data, [SHS.DROIT]Humanities and Social Sciences/Law, CNIL, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Textes réglementaires, Protection des données, [SDV.ETH]Life Sciences [q-bio]/Ethics
Abstract

International audience; La recherche clinique, menée sur des sujets humains ou à partir de leurs données, se trouve confrontée à des exigences contradictoires, avec, d’une part, le principe de science ouverte (transparence et partage des données), les possibilités offertes par les « big data » et la réutilisation des données issues de la recherche ou du soin et, d’autre part, l’encadrement réglementaire et législatif qui évolue, avec notamment le règlement général sur la protection des données ou RGPD. Une table ronde était organisée à Giens en octobre 2018, afin d’identifier les zones de tension, les besoins de clarification et de fluidification, et de faire des recommandations visant à promouvoir la recherche clinique tout en assurant un haut niveau de protection des patients. Après une mise au point effectuée en commun sur ces évolutions, les participants à la table ronde ont pu proposer des recommandations, dont les principales sont (1) de clarifier : ce qui est considéré comme données anonymisées et ce que représente « l’intérêt public » au sens du RGPD ; (2) de poursuivre le développement des méthodologies de référence par la CNIL ; (3) de promouvoir l’utilisation secondaire des données, en facilitant une information et un consentement élargi des patients, en clarifiant les circonstances d’application de leurs droits de retrait, d’opposition, de façon à limiter le risque de biais ; (4) faciliter l’accès aux entrepôts de données par la mise à disposition de supports technologiques et méthodologiques. Enfin, développer les échanges au niveau européen entre autorités sur les sujets de recherche, promouvoir la participation des autorités françaises à l’élaboration des codes de conduite, et la mise en place d’une procédure d’harmonisation volontaire pour coordonner les avis des autorités de protection des données, tout en s’assurant que les principaux documents soient disponibles en langue anglaise.

Published
2019

32. European mental health research resources: Picture and recommendations of the ROAMER project

Author

Hersenen-Medisch 1, Brain, Hazo, Jean-Baptiste, Brunn, Matthias, Wykes, Til, McDaid, David, Dorsey, Maya, Demotes-Mainard, Jacques, van der Feltz-Cornelis, Christina M., Wahlbeck, Kristian, Knappe, Susanne, Meyer-Lindenberg, Andreas, Obradors-Tarrago, Carla, Haro, Josep Maria, Leboyer, Marion, Chevreul, Karine, Robbins, Trevor W., Lewis, Shon, Evans-Lacko, Sara, Belli, Stefano, Bitter, Istvan, Wittchen, Hans-Ulrich, Fiorillo, Andrea, Luciano, Mario, Van Os, Jim, Hersenen-Medisch 1, Brain, Hazo, Jean-Baptiste, Brunn, Matthias, Wykes, Til, McDaid, David, Dorsey, Maya, Demotes-Mainard, Jacques, van der Feltz-Cornelis, Christina M., Wahlbeck, Kristian, Knappe, Susanne, Meyer-Lindenberg, Andreas, Obradors-Tarrago, Carla, Haro, Josep Maria, Leboyer, Marion, Chevreul, Karine, Robbins, Trevor W., Lewis, Shon, Evans-Lacko, Sara, Belli, Stefano, Bitter, Istvan, Wittchen, Hans-Ulrich, Fiorillo, Andrea, Luciano, Mario, and Van Os, Jim

Published
2019

33. Therapeutic hypothermia for acute ischaemic stroke:Results of a European multicentre, randomised, phase III clinical trial

Author

van der Worp, H Bart, Macleod, Malcolm R, Bath, Philip Mw, Bathula, Raj, Christensen, Hanne, Colam, Bridget, Cordonnier, Charlotte, Demotes-Mainard, Jacques, Durand-Zaleski, Isabelle, Gluud, Christian, Jakobsen, Janus Christian, Kallmünzer, Bernd, Kollmar, Rainer, Krieger, Derk W, Lees, Kennedy R, Michalski, Dominik, Molina, Carlos, Montaner, Joan, Roine, Risto O, Petersson, Jesper, Perry, Richard, Sprigg, Nikola, Staykov, Dimitre, Szabo, Istvan, Vanhooren, Geert, Wardlaw, Joanna M, Winkel, Per, Schwab, Stefan, van der Worp, H Bart, Macleod, Malcolm R, Bath, Philip Mw, Bathula, Raj, Christensen, Hanne, Colam, Bridget, Cordonnier, Charlotte, Demotes-Mainard, Jacques, Durand-Zaleski, Isabelle, Gluud, Christian, Jakobsen, Janus Christian, Kallmünzer, Bernd, Kollmar, Rainer, Krieger, Derk W, Lees, Kennedy R, Michalski, Dominik, Molina, Carlos, Montaner, Joan, Roine, Risto O, Petersson, Jesper, Perry, Richard, Sprigg, Nikola, Staykov, Dimitre, Szabo, Istvan, Vanhooren, Geert, Wardlaw, Joanna M, Winkel, Per, and Schwab, Stefan

Abstract

Introduction: We assessed whether modest systemic cooling started within 6 hours of symptom onset improves functional outcome at three months in awake patients with acute ischaemic stroke.Patients and methods: In this European randomised open-label clinical trial with blinded outcome assessment, adult patients with acute ischaemic stroke were randomised to cooling to a target body temperature of 34.0-35.0°C, started within 6 h after stroke onset and maintained for 12 or 24 h , versus standard treatment. The primary outcome was the score on the modified Rankin Scale at 91 days, as analysed with ordinal logistic regression.Results: The trial was stopped after inclusion of 98 of the originally intended 1500 patients because of slow recruitment and cessation of funding. Forty-nine patients were randomised to hypothermia versus 49 to standard treatment. Four patients were lost to follow-up. Of patients randomised to hypothermia, 15 (31%) achieved the predefined cooling targets. The primary outcome did not differ between the groups (odds ratio for good outcome, 1.01; 95% confidence interval, 0.48-2.13; p = 0.97). The number of patients with one or more serious adverse events did not differ between groups (relative risk, 1.22; 95% confidence interval, 0.65-1.94; p = 0.52).Discussion: In this trial, cooling to a target of 34.0-35.0°C and maintaining this for 12 or 24 h was not feasible in the majority of patients. The final sample was underpowered to detect clinically relevant differences in outcomes.Conclusion: Before new trials are launched, the feasibility of cooling needs to be improved.

Published
2019

36. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Author

Gluud Christian, Kubiak Christine, Whitfield Kate, Byrne Jane, Huemer Karl-Heinz, Thirstrup Steffen, Libersa Christian, Barraud Béatrice, Grählert Xina, Dreier Gabriele, Geismann Sebastian, Kuchinke Wolfgang, Temesvari Zsuza, Blasko Gyorgy, Kardos Gabriella, O'Brien Timothy, Cooney Margaret, Gaynor Siobhan, Schieppati Arrigo, de Andres Fernando, Sanz Nuria, Kreis German, Asker-Hagelberg Charlotte, Johansson Hanna, Bourne Sue, Asghar Adeeba, Husson Jean-Marc, and Demotes-Mainard Jacques

Subjects
Medicine (General), R5-920
Abstract

Abstract Background In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. Methods We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries. Results Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised. Conclusion The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.

Published
2012
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37. Report About A Workshop On Sensitive Data: Repositories For Sharing Individual Participant Data From Clinical Trials And Existing Tools/Services For Storing Clinical Trial Data

Author

Banzi, Rita, Canham, Steve, Ohmann, Christian, Kuchinke, Wolfgang, Krleza-Jeric, Karmela, Tilki, Birol, Battaglia, Serena, and Demotes-Mainard, Jacques

Subjects
repository, services, data storage, data sharing, tools, CORBEL, clinical trial, individual participant data
Abstract

The workshop on sensitive data was performed within the CORBEL project and was held on 14 June 2018 in Paris, France. The report was prepared by the CORBEL WT3.3 project group and covers the following areas: 1. Background (from the CORBEL project) 2. Assessment of existing repositories for sharing individual participant data (IPD) from clinical trials (Study protocol (March 2018), Status report on assessment of data repositories (June 2018)) 3. Survey of existing tools/services for storing clinical trial data &nbsp

Published
2018

38. Quel impact du nouveau règlement européen sur la protection des données sur la recherche clinique et recommandations

Author

Demotes-Mainard, Jacques, primary, Cornu, Catherine, additional, Guérin, Aurélie, additional, Bertoye, Pierre-Henri, additional, Boidin, Romain, additional, Bureau, Serge, additional, Chrétien, Jean-Marie, additional, Delval, Cécile, additional, Deplanque, Dominique, additional, Dubray, Claude, additional, Duchossoy, Luc, additional, Edel, Valérie, additional, Fouret, Cécile, additional, Galaup, Ariane, additional, Lesaulnier, Frédérique, additional, Matei, Mihaela, additional, Naudet, Florian, additional, Plattner, Valérie, additional, Rubio, Michel, additional, Ruiz, Fabrice, additional, Sénéchal-Cohen, Sophie, additional, Simon, Tabassome, additional, Vidal, Anne, additional, Viola, Anne, additional, and Violleau, Mireille, additional

Published
2019
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39. How the new European data protection regulation affects clinical research and recommendations?

Author

Demotes-Mainard, Jacques, primary, Cornu, Catherine, additional, Guérin, Aurélie, additional, Bertoye, Pierre-Henri, additional, Boidin, Romain, additional, Bureau, Serge, additional, Chrétien, Jean-Marie, additional, Delval, Cécile, additional, Deplanque, Dominique, additional, Dubray, Claude, additional, Duchossoy, Luc, additional, Edel, Valérie, additional, Fouret, Cécile, additional, Galaup, Ariane, additional, Lesaulnier, Frédérique, additional, Matei, Mihaela, additional, Naudet, Florian, additional, Plattner, Valérie, additional, Rubio, Michel, additional, Ruiz, Fabrice, additional, Sénéchal-Cohen, Sophie, additional, Simon, Tabassome, additional, Vidal, Anne, additional, Viola, Anne, additional, and Violleau, Mireille, additional

Published
2019
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40. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Author

Sanz Nuria, Schieppati Arrigo, Gaynor Siobhan, O'Brien Timothy, Cooney Margaret, Kardos Gabriella, Blasko Gyorgy, Temesvari Zsuzsa, Grychtol Ruth, Dreier Gabriele, Grählert Xina, Barraud Béatrice, Libersa Christian, Whitfield Kate, Thirstrup Steffen, Huemer Karl-Heinz, Kuchinke Wolfgang, de Andres-Trelles Fernando, Kubiak Christine, Hernandez Raquel, Asker-Hagelberg Charlotte, Johansson Hanna, Bourne Sue, Byrne Jane, Asghar Adeeba, Husson Jean-Marc, Gluud Christian, and Demotes-Mainard Jacques

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.

Published
2009
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42. Additional file 3: of Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

Author

Laville, Martine, Segrestin, Berenice, Alligier, Maud, Ruano-RodrĂ­Guez, Cristina, Serra-Majem, Lluis, Hiesmayr, Michael, Schols, Annemie, Vecchia, Carlo La, Boirie, Yves, Rath, Ana, Neugebauer, Edmund, Garattini, Silvio, Bertele, Vittorio, Kubiak, Christine, Demotes-Mainard, Jacques, Jakobsen, Janus, Djurisic, Snezana, and Gluud, Christian

Abstract

Relevant references from the academic literature search. Results from the academic literature search are listed in the form of relevant publications. (DOCX 14 kb)

Published
2017
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43. Sharing and reuse of individual participant data from clinical trials: principles and recommendations

Author

Ohmann, Christian, primary, Banzi, Rita, additional, Canham, Steve, additional, Battaglia, Serena, additional, Matei, Mihaela, additional, Ariyo, Christopher, additional, Becnel, Lauren, additional, Bierer, Barbara, additional, Bowers, Sarion, additional, Clivio, Luca, additional, Dias, Monica, additional, Druml, Christiane, additional, Faure, Hélène, additional, Fenner, Martin, additional, Galvez, Jose, additional, Ghersi, Davina, additional, Gluud, Christian, additional, Groves, Trish, additional, Houston, Paul, additional, Karam, Ghassan, additional, Kalra, Dipak, additional, Knowles, Rachel L, additional, Krleža-Jerić, Karmela, additional, Kubiak, Christine, additional, Kuchinke, Wolfgang, additional, Kush, Rebecca, additional, Lukkarinen, Ari, additional, Marques, Pedro Silverio, additional, Newbigging, Andrew, additional, O’Callaghan, Jennifer, additional, Ravaud, Philippe, additional, Schlünder, Irene, additional, Shanahan, Daniel, additional, Sitter, Helmut, additional, Spalding, Dylan, additional, Tudur-Smith, Catrin, additional, van Reusel, Peter, additional, van Veen, Evert-Ben, additional, Visser, Gerben Rienk, additional, Wilson, Julia, additional, and Demotes-Mainard, Jacques, additional

Published
2017
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44. A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome?

Author

Rath, Ana, primary, Salamon, Valérie, additional, Peixoto, Sandra, additional, Hivert, Virginie, additional, Laville, Martine, additional, Segrestin, Berenice, additional, Neugebauer, Edmund A. M., additional, Eikermann, Michaela, additional, Bertele, Vittorio, additional, Garattini, Silvio, additional, Wetterslev, Jørn, additional, Banzi, Rita, additional, Jakobsen, Janus C., additional, Djurisic, Snezana, additional, Kubiak, Christine, additional, Demotes-Mainard, Jacques, additional, and Gluud, Christian, additional

Published
2017
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45. Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency

Author

Dal-Re, Rafael, Moher, David, Gluud, Christian, Treweek, Shaun, Demotes-Mainard, Jacques, and Carne, Xavier

Subjects
Clinical trials -- Usage, Medical ethics -- Research, Biological sciences
Abstract

Transparency: A Fundamental Social Obligation for Clinical Research After 60 years devoted to enhancing the methodology and ethics in clinical research, the last decade has been crucial to the scientific [...]

Published
2011
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46. Survey on the deployment model of a Clinical Data Management System under development (VISTA Trials)

Author

Ohmann, Christian, Canham, Steve, Vogt, Andreas, Ruyskart, Pascal, and Demotes-Mainard, Jacques

Subjects
Clinical trial, SaaS, European Clinical Research Infrastructures Network (ECRIN), Deployment, Survey, Data management, Clinical Data Management System (CDMS), European Organisation for Research and Treatment of Cancer (EORTC)
Abstract

Background: Academic clinical trials units have traditionally maintained their Clinical Data Management Systems (CDMS) on their own premises or those of their parent organisation (e.g. university). There is growing use, however, of 'SaaS' or 'Software as a Service' systems, in which the CDMS is hosted externally by another organisation and access from the trials unit is web-based. ECRIN is supporting the development of a new CDMS ('Vista Trials') by EORTC, which will only offer a SaaS based deployment model. Because opinions vary widely about the suitability of the SaaS model, ECRIN felt it was important to clarify the acceptability of such a system to academic trials units. Methods: An online survey was created, using 'Survey Monkey', and sent to 129 academic trials units in Europe. After asking for brief details about the unit and existing systems, the survey asked how acceptable the proposed SaaS deployment method would be and why, and explored factors that would make the deployment more or less attractive. Results: 53 trials units responded from 14 countries (41.1%). The proposed SaaS deployment model was acceptable to 53% of respondents, with smaller units, and those interested in changing their current system, relatively favourable to the model. Key factors appeared to be views on data security and data access but many others were mentioned. Some opinions were relatively dogmatic – 8 units claimed SaaS was essential for them whilst 11 rejected it as 'a matter of principle'. There also seemed some confusion about regulatory compliance of SaaS based systems: 44% saw no problem, 19% identified an issue and 37% were not sure. Conclusions: The range of opinions expressed about SaaS implies a similar range in the assumptions units have about this type of deployment, e.g. about the security and access implications. Coupled with the uncertainties over compliance, this indicates a need for organisations like ECRIN to work with regulators, system vendors, hosting organisations, and trials units to clarify the risks and issues. This would inform the future development of the SaaS model for clinical trials systems, and help individual units make decisions about the best way of managing their CDMS.

Published
2016
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47. Global health: Boost multinational clinical research

Author

Demotes-Mainard, Jacques

Subjects
Medical societies -- Aims and objectives, Medical research -- International aspects, International cooperation -- Research -- Methods, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

Author(s): Jacques Demotes-Mainard (corresponding author) [1] Global cooperation in clinical research maximizes access to patients, enables resource sharing and increases the applicability of research findings. Yet academic trials are rarely [...]

Published
2017
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49. Specific barriers to the conduct of randomised clinical trials on medical devices

Author

Neugebauer, Edmund A. M., primary, Rath, Ana, additional, Antoine, Sunya-Lee, additional, Eikermann, Michaela, additional, Seidel, Doerthe, additional, Koenen, Carsten, additional, Jacobs, Esther, additional, Pieper, Dawid, additional, Laville, Martine, additional, Pitel, Séverine, additional, Martinho, Cecilia, additional, Djurisic, Snezana, additional, Demotes-Mainard, Jacques, additional, Kubiak, Christine, additional, Bertele, Vittorio, additional, Jakobsen, Janus C., additional, Garattini, Silvio, additional, and Gluud, Christian, additional

Published
2017
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50. Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

Author

Laville, Martine, primary, Segrestin, Berenice, additional, Alligier, Maud, additional, Ruano-Rodríguez, Cristina, additional, Serra-Majem, Lluis, additional, Hiesmayr, Michael, additional, Schols, Annemie, additional, La Vecchia, Carlo, additional, Boirie, Yves, additional, Rath, Ana, additional, Neugebauer, Edmund A. M., additional, Garattini, Silvio, additional, Bertele, Vittorio, additional, Kubiak, Christine, additional, Demotes-Mainard, Jacques, additional, Jakobsen, Janus C., additional, Djurisic, Snezana, additional, and Gluud, Christian, additional

Published
2017
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