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2. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Sánchez-Montalva, Adrian, Estevez, Ana Belén, Sánchez, Àlex, Sanjuan, Anna, Sena, Elena, Granados, Emma, Arévalo de Andrés, Esther, Nuñez, Fátima, Arteaga, Gara, Fuentes Ruiz, Gabriela Perez, Fernández, Guillermo, Rivera-Esteban, Jesus, Comella, Joan, Ramos-Quiroga, Josep Antoni, Genescà, Joan, Espinosa, Juan, Pericàs, Juan Manuel, Murcia, Lada, Cash-Gibson, Lucinda, de Valles Silvosa, Maria, Barroso de Sousa, María Fernanda, Sánchez-Maroto Carrizo, Olga, Ibañez-Jiménez, Pol, Augustin, Salvador, Perez-Hoyos, Santiago, Rodríguez-Navarro, Sarai, Muñoz-Martínez, Sergio, Serres, Silvia, Kalko, Susana, Michon, Amelie, Ussi, Anton, Lydall, Ben, van de Ketterij, Edwin, Quiles, Ignacio, Carapina, Tamara, Kumaus, Constantin, Ramazanova, Dariga, Meyer, Elias Laurin, Koenig, Franz, Roig, Marta Bofill, Brunner, Martin, Posch, Martin, Krotka, Pavla, Zehetmayer, Sonja, Carton, Charlotte, Legius, Eric, Begum, Amina, Pariante, Carmine, Worrell, Courtney, Lombardo, Giulia, Sforzini, Luca, Brown, Mollie, Gullet, Nancy, Amasi-Hartoonian, Nare, Ferner, Rosalie, Kose, Melisa, Spitaleri, Andrea, Ghodousi, Arash, Di Serio, Clelia, Cirillo, Daniela, Cugnata, Federica, Saluzzo, Francesca, Benedetti, Francesco, Scarale, Maria Giovanna, Zini, Michela, Rancoita, Paola Maria, Alagna, Riccardo, Poletti, Sara, Dhaenens, Britt, Van Der Lei, Johan, de Steenwinkel, Jurriaan, Moinat, Maxim, Oostenbrink, Rianne, Hoogendijk, Witte, Hölscher, Michael, Heinrich, Norbert, Otte, Christian, Potratz, Cornelia, Zocholl, Dario, Kulakova, Eugenia, Tacke, Frank, Brasanac, Jelena, Leubner, Jonas, Krajewska, Maja, Freitag, Michaela Maria, Gold, Stefan, Zoller, Thomas, Chae, Woo Ri, Daniel, Christel, Kara, Leila, Vaterkowski, Morgan, Griffon, Nicolas, Wolkenstein, Pierre, Pais, Raluca, Ratziu, Vlad, Voets, David, Maes, Christophe, Kalra, Dipak, Thienpoint, Geert, Deckerck, Jens, Lea, Nathan, Singleton, Peter, Viele, Kert, Jacko, Peter, Berry, Scott, Parke, Tom, Aydin, Burç, Kubiak, Christine, Demotes, Jacques, Ueda, Keiko, Matei, Mihaela, Contrino, Sergio, Röhl, Claas, Cordero, Estefania, Greenhalgh, Fiona, Jarke, Hannes, Angelova, Juliana, Boudes, Mathieu, Dressler, Stephan, Strammiello, Valentina, Anstee, Quentin, Gutierrez-Ibarluzea, Iñaki, Otte, Maximilian, Heimbach, Natalie, Hofner, Benjamin, Burgwinkel, Cora, Kaestel, Hue, Hees, Katharina, Nguyen, Quynh, Prieto-Alhambra, Daniel, Tan, Eng Hooi (Cheryl), Raviglione, Mario, de Colombani, Pierpaolo, Villa, Simone, Maron, Eduard, Evans, Gareth, Savitz, Adam J., Van Dessel, Ann, Duca, Anna, Kaminski, Anne, Wouters, Bie, Porter, Brandon, Charron, Catherine, Spiertz, Cecile, Zizzamia, Christopher, Millar, Daniel, Hasselbaink, Danny, Orr, David, Kesters, Divya, Hubin, Ellen, Davies, Emma, Didden, Eva-Maria, Guz, Gabriela, Verstraete, Evelyn, Mao, Gary, Capuano, George, Martynowicz, Heddie, De Smedt, Heidi, Larsson, Ingela, Bruegelmans, Ines, Coste, Isabelle, Gonzalez Moreno, Jesus Maria, Niewczas, Julia, Xu, Jiajun, Rombouts, Karin, Woo, Katherine, Wuyts, Kathleen, Hersh, Kathryn, Oldenburg, Khrista, Zhang, Lingjiao, Schmidt, Mark, Szuch, Mark, Todorovic, Marija, Mangelaars, Maartje, Grewal, Melissa, Sandor, Molli, Di Prospero, Nick, Van Houten, Pamela, Minnick, Pansy, Bastos, Polyana, Patrizi, Robert, Morello, Salvatore, De Wilde, Severijn, Sun, Tao, Kline, Timothy, de Marez, Tine, Mielke, Tobias, Reijns, Tom, Popova, Vanina, Flossbach, Yanina, Tymofyeyev, Yevgen, De Groote, Zeger, Sverdlov, Alex, Bobirca, Alexandra, Krause, Annekatrin, Bobrica, Catalin, Heintz, Daniela, Magirr, Dominic, Glimm, Ekkehard, Baffert, Fabienne, Castiglione, Federica, Caruso, Franca, Patalano, Francesco, Bretz, Frank, Heimann, Guenter, Carbarns, Ian, Rodríguez, Ignacio, Ratescu, Ioana, Hampson, Lisa, Pedrosa, Marcos, Hark, Mareile, Mesenbrink, Peter, Penna, Sabina Hernandez, Bergues-Lang, Sarah, Baltes-Engler, Susanne, Arsiwala, Tasneem, Mondragon, Valeria Jordan, Guo, Hua, Da Costa, Jose Leite, Burman, Carl-Fredrik, Kirk, George, Aaes-Jørgensen, Anders, Dirach, Jorgen, Kjær, Mette Skalshøi, Martin, Alexandra, Hristov, Diyan, Rousseaux, Florent, Hittel, Norbert, Dornheim, Robert, Evans, Daniel, Sykes, Nick, Couvert, Camille, Leuven, Catherine, Notelet, Loïc, Gidh-Jain, Madhavi, Jouannin, Mathieu, Ammour, Nadir, Pierre, Suzanne, Haufe, Volker, Dong, Yingwen, Dubanchet, Catherine, de Préville, Nathalie, Baltauss, Tania, Jian, Zhu, Shnider, Sara, Bar-El, Tal, Bakker, Annette, Nievo, Marco, Iloeje, Uche, Conradie, Almari, Auffarrth, Ece, Lombard, Leandra, Benhayoun, Majda, Olugbosi, Morounfolu, Seidel, Stephanie S., Gumí, Berta, Guzmán, Claudia García, Molero, Eva, Pairó, Gisela, Machin, Núria, Cardelús, Raimon, Ramasastry, Saira, Pelzer, Saskia, Kremer, Andreas, Lindfors, Erno, Lynch, Chris, Spiertz, Cécile, Machín, Núria, and Pericàs, Juan M.

Published
2024
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3. Prevention of infections and fever to improve outcome in older patients with acute stroke (PRECIOUS): a randomised, open, phase III, multifactorial, clinical trial with blinded outcome assessment

Author

Kerkhoff, Henk, Wermer, Marieke JH., Jellema, Korné, Kwa, Vincent IH., Jansen, Ben P., Schreuder, Tobien AHCML., Zinkstok, Sanne M., Moudrous, Walid, Antsov, Katrin, Gross-Paju, Katrin, Kalju, Inga, Hamann, Gerhard F., Rosenkranz, Michael, Gumbinger, Christoph, Royl, Georg, Müller, Susanne, Vassilopoulou, Sophie, Protogerou, Athanasios D., Manios, Efstathios, Bereczki, Dániel, Jakab, Gábor, Nagy, Ferenc, Folyovich, András, Szapáry, László, Gilberti, Nicola, Righetti, Enrico, Bassi, Pietro, Marcheselli, Simona, Giossi, Alessia, Holtan, Anne G., Maini, Sameer, Fryze, Waldemar, Brola, Waldemar, Sobolewski, Piotr, Bilik, Marta, Davies, Ruth, Nair, Anand, Dutta, Dipankar, Cooper, Martin, Rashed, Khalid, Shaw, Louise, Selvarajah, Johann R., Redgrave, Jessica, MacLeod, Mary Joan, Clatworthy, Philip, Papavasileiou, Vasileios, Cvoro, Vera, Halse, Omid, Ghani, Usman, de Jonge, Jeroen C., Sluis, Wouter M., Reinink, Hendrik, Bath, Philip M., Woodhouse, Lisa J., Zweedijk, Berber, van de Beek, Diederik, Aamodt, Anne Hege, Alpers, Iris, Ciccone, Alfonso, Csiba, Laszlo, Demotes, Jacques, Kõrv, Janika, Kurkowska-Jastrzebska, Iwona, Dawson, Jesse, Macleod, Malcolm R., Ntaios, George, Poli, Sven, Milionis, Haralampos, Ricci, Stefano, Cenciarelli, Silvia, Candelaresi, Paolo, de Bruijn, Sebastiaan FTM., Pathansali, Rohan, Krishnan, Kailash, Clarke, Brian, Thomalla, Götz, and van der Worp, H Bart

Published
2024
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4. Platform trials

Author

Roustit, Matthieu, Demarcq, Olivier, Laporte, Silvy, Barthélémy, Philippe, Chassany, Olivier, Cucherat, Michel, Demotes, Jacques, Diebolt, Vincent, Espérou, Hélène, Fouret, Cécile, Galaup, Ariane, Gambotti, Laetitia, Gourio, Charlotte, Guérin, Aurélie, Labruyère, Carine, Paoletti, Xavier, Porcher, Raphael, Simon, Tabassome, and Varoqueaux, Nathalie

Published
2023
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5. Les essais plateformes

Author

Roustit, Matthieu, Demarcq, Olivier, Laporte, Silvy, Barthélémy, Philippe, Chassany, Olivier, Cucherat, Michel, Demotes, Jacques, Diebolt, Vincent, Espérou, Hélène, Fouret, Cécile, Galaup, Ariane, Gambotti, Laetitia, Gourio, Charlotte, Guérin, Aurélie, Labruyère, Carine, Paoletti, Xavier, Porcher, Raphael, Simon, Tabassome, and Varoqueaux, Nathalie

Published
2023
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6. The Global academic research organization network: Data sharing to cure diseases and enable learning health systems.

Author

Fukushima, Masanori, Austin, Christopher, Sato, Norihiro, Maruyama, Tatsuya, Navarro, Eileen, Rocca, Mitra, Demotes, Jacques, Haendel, Melissa, Volchenboum, Samuel L, Cowperthwaite, Matthew, Silverstein, Jonathan C, Webb, Chris, Sim, Ida, Chase, Marianne, Speakman, John, Augustine, Erika, Ford, Daniel E, and Kush, Rebecca

Subjects
data sharing, global, harmonization, registry, standards
Abstract

Introduction:Global data sharing is essential. This is the premise of the Academic Research Organization (ARO) Council, which was initiated in Japan in 2013 and has since been expanding throughout Asia and into Europe and the United States. The volume of data is growing exponentially, providing not only challenges but also the clear opportunity to understand and treat diseases in ways not previously considered. Harnessing the knowledge within the data in a successful way can provide researchers and clinicians with new ideas for therapies while avoiding repeats of failed experiments. This knowledge transfer from research into clinical care is at the heart of a learning health system. Methods:The ARO Council wishes to form a worldwide complementary system for the benefit of all patients and investigators, catalyzing more efficient and innovative medical research processes. Thus, they have organized Global ARO Network Workshops to bring interested parties together, focusing on the aspects necessary to make such a global effort successful. One such workshop was held in Austin, Texas, in November 2017. Representatives from Japan, Taiwan, Singapore, Europe, and the United States reported on their efforts to encourage data sharing and to use research to inform care through learning health systems. Results:This experience report summarizes presentations and discussions at the Global ARO Network Workshop held in November 2017 in Austin, TX, with representatives from Japan, Korea, Singapore, Taiwan, Europe, and the United States. Themes and recommendations to progress their efforts are explored. Standardization and harmonization are at the heart of these discussions to enable data sharing. In addition, the transformation of clinical research processes through disruptive innovation, while ensuring integrity and ethics, will be key to achieving the ARO Council goal to overcome diseases such that people not only live longer but also are healthier and happier as they age. Conclusions:The achievement of global learning health systems will require further exploration, consensus-building, funding aligned with incentives for data sharing, standardization, harmonization, and actions that support global interests for the benefit of patients.

Published
2019

7. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Koenig, Franz, primary, Spiertz, Cécile, additional, Millar, Daniel, additional, Rodríguez-Navarro, Sarai, additional, Machín, Núria, additional, Van Dessel, Ann, additional, Genescà, Joan, additional, Pericàs, Juan M., additional, Posch, Martin, additional, Sánchez-Montalva, Adrian, additional, Estevez, Ana Belén, additional, Sánchez, Àlex, additional, Sanjuan, Anna, additional, Sena, Elena, additional, Granados, Emma, additional, Arévalo de Andrés, Esther, additional, Nuñez, Fátima, additional, Arteaga, Gara, additional, Fuentes Ruiz, Gabriela Perez, additional, Fernández, Guillermo, additional, Rivera-Esteban, Jesus, additional, Comella, Joan, additional, Ramos-Quiroga, Josep Antoni, additional, Espinosa, Juan, additional, Pericàs, Juan Manuel, additional, Murcia, Lada, additional, Cash-Gibson, Lucinda, additional, de Valles Silvosa, Maria, additional, Barroso de Sousa, María Fernanda, additional, Sánchez-Maroto Carrizo, Olga, additional, Ibañez-Jiménez, Pol, additional, Augustin, Salvador, additional, Perez-Hoyos, Santiago, additional, Muñoz-Martínez, Sergio, additional, Serres, Silvia, additional, Kalko, Susana, additional, Michon, Amelie, additional, Ussi, Anton, additional, Lydall, Ben, additional, van de Ketterij, Edwin, additional, Quiles, Ignacio, additional, Carapina, Tamara, additional, Kumaus, Constantin, additional, Ramazanova, Dariga, additional, Meyer, Elias Laurin, additional, Koenig, Franz, additional, Roig, Marta Bofill, additional, Brunner, Martin, additional, Krotka, Pavla, additional, Zehetmayer, Sonja, additional, Carton, Charlotte, additional, Legius, Eric, additional, Begum, Amina, additional, Pariante, Carmine, additional, Worrell, Courtney, additional, Lombardo, Giulia, additional, Sforzini, Luca, additional, Brown, Mollie, additional, Gullet, Nancy, additional, Amasi-Hartoonian, Nare, additional, Ferner, Rosalie, additional, Kose, Melisa, additional, Spitaleri, Andrea, additional, Ghodousi, Arash, additional, Di Serio, Clelia, additional, Cirillo, Daniela, additional, Cugnata, Federica, additional, Saluzzo, Francesca, additional, Benedetti, Francesco, additional, Scarale, Maria Giovanna, additional, Zini, Michela, additional, Rancoita, Paola Maria, additional, Alagna, Riccardo, additional, Poletti, Sara, additional, Dhaenens, Britt, additional, Van Der Lei, Johan, additional, de Steenwinkel, Jurriaan, additional, Moinat, Maxim, additional, Oostenbrink, Rianne, additional, Hoogendijk, Witte, additional, Hölscher, Michael, additional, Heinrich, Norbert, additional, Otte, Christian, additional, Potratz, Cornelia, additional, Zocholl, Dario, additional, Kulakova, Eugenia, additional, Tacke, Frank, additional, Brasanac, Jelena, additional, Leubner, Jonas, additional, Krajewska, Maja, additional, Freitag, Michaela Maria, additional, Gold, Stefan, additional, Zoller, Thomas, additional, Chae, Woo Ri, additional, Daniel, Christel, additional, Kara, Leila, additional, Vaterkowski, Morgan, additional, Griffon, Nicolas, additional, Wolkenstein, Pierre, additional, Pais, Raluca, additional, Ratziu, Vlad, additional, Voets, David, additional, Maes, Christophe, additional, Kalra, Dipak, additional, Thienpoint, Geert, additional, Deckerck, Jens, additional, Lea, Nathan, additional, Singleton, Peter, additional, Viele, Kert, additional, Jacko, Peter, additional, Berry, Scott, additional, Parke, Tom, additional, Aydin, Burç, additional, Kubiak, Christine, additional, Demotes, Jacques, additional, Ueda, Keiko, additional, Matei, Mihaela, additional, Contrino, Sergio, additional, Röhl, Claas, additional, Cordero, Estefania, additional, Greenhalgh, Fiona, additional, Jarke, Hannes, additional, Angelova, Juliana, additional, Boudes, Mathieu, additional, Dressler, Stephan, additional, Strammiello, Valentina, additional, Anstee, Quentin, additional, Gutierrez-Ibarluzea, Iñaki, additional, Otte, Maximilian, additional, Heimbach, Natalie, additional, Hofner, Benjamin, additional, Burgwinkel, Cora, additional, Kaestel, Hue, additional, Hees, Katharina, additional, Nguyen, Quynh, additional, Prieto-Alhambra, Daniel, additional, Tan, Eng Hooi (Cheryl), additional, Raviglione, Mario, additional, de Colombani, Pierpaolo, additional, Villa, Simone, additional, Maron, Eduard, additional, Evans, Gareth, additional, Savitz, Adam J., additional, Duca, Anna, additional, Kaminski, Anne, additional, Wouters, Bie, additional, Porter, Brandon, additional, Charron, Catherine, additional, Spiertz, Cecile, additional, Zizzamia, Christopher, additional, Hasselbaink, Danny, additional, Orr, David, additional, Kesters, Divya, additional, Hubin, Ellen, additional, Davies, Emma, additional, Didden, Eva-Maria, additional, Guz, Gabriela, additional, Verstraete, Evelyn, additional, Mao, Gary, additional, Capuano, George, additional, Martynowicz, Heddie, additional, De Smedt, Heidi, additional, Larsson, Ingela, additional, Bruegelmans, Ines, additional, Coste, Isabelle, additional, Gonzalez Moreno, Jesus Maria, additional, Niewczas, Julia, additional, Xu, Jiajun, additional, Rombouts, Karin, additional, Woo, Katherine, additional, Wuyts, Kathleen, additional, Hersh, Kathryn, additional, Oldenburg, Khrista, additional, Zhang, Lingjiao, additional, Schmidt, Mark, additional, Szuch, Mark, additional, Todorovic, Marija, additional, Mangelaars, Maartje, additional, Grewal, Melissa, additional, Sandor, Molli, additional, Di Prospero, Nick, additional, Van Houten, Pamela, additional, Minnick, Pansy, additional, Bastos, Polyana, additional, Patrizi, Robert, additional, Morello, Salvatore, additional, De Wilde, Severijn, additional, Sun, Tao, additional, Kline, Timothy, additional, de Marez, Tine, additional, Mielke, Tobias, additional, Reijns, Tom, additional, Popova, Vanina, additional, Flossbach, Yanina, additional, Tymofyeyev, Yevgen, additional, De Groote, Zeger, additional, Sverdlov, Alex, additional, Bobirca, Alexandra, additional, Krause, Annekatrin, additional, Bobrica, Catalin, additional, Heintz, Daniela, additional, Magirr, Dominic, additional, Glimm, Ekkehard, additional, Baffert, Fabienne, additional, Castiglione, Federica, additional, Caruso, Franca, additional, Patalano, Francesco, additional, Bretz, Frank, additional, Heimann, Guenter, additional, Carbarns, Ian, additional, Rodríguez, Ignacio, additional, Ratescu, Ioana, additional, Hampson, Lisa, additional, Pedrosa, Marcos, additional, Hark, Mareile, additional, Mesenbrink, Peter, additional, Penna, Sabina Hernandez, additional, Bergues-Lang, Sarah, additional, Baltes-Engler, Susanne, additional, Arsiwala, Tasneem, additional, Mondragon, Valeria Jordan, additional, Guo, Hua, additional, Da Costa, Jose Leite, additional, Burman, Carl-Fredrik, additional, Kirk, George, additional, Aaes-Jørgensen, Anders, additional, Dirach, Jorgen, additional, Kjær, Mette Skalshøi, additional, Martin, Alexandra, additional, Hristov, Diyan, additional, Rousseaux, Florent, additional, Hittel, Norbert, additional, Dornheim, Robert, additional, Evans, Daniel, additional, Sykes, Nick, additional, Couvert, Camille, additional, Leuven, Catherine, additional, Notelet, Loïc, additional, Gidh-Jain, Madhavi, additional, Jouannin, Mathieu, additional, Ammour, Nadir, additional, Pierre, Suzanne, additional, Haufe, Volker, additional, Dong, Yingwen, additional, Dubanchet, Catherine, additional, de Préville, Nathalie, additional, Baltauss, Tania, additional, Jian, Zhu, additional, Shnider, Sara, additional, Bar-El, Tal, additional, Bakker, Annette, additional, Nievo, Marco, additional, Iloeje, Uche, additional, Conradie, Almari, additional, Auffarrth, Ece, additional, Lombard, Leandra, additional, Benhayoun, Majda, additional, Olugbosi, Morounfolu, additional, Seidel, Stephanie S., additional, Gumí, Berta, additional, Guzmán, Claudia García, additional, Molero, Eva, additional, Pairó, Gisela, additional, Machin, Núria, additional, Cardelús, Raimon, additional, Ramasastry, Saira, additional, Pelzer, Saskia, additional, Kremer, Andreas, additional, Lindfors, Erno, additional, and Lynch, Chris, additional

Published
2024
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9. EOSC-Life Report about use and user satisfaction of the COVID-19 repository, including a maintenance and sustainability plan

Author

Contrino, Sergio, Felder, Gerd, Ohmann, Christian, Panagiotopoulou, Maria, Kichenassamy, Swarnalathaa, Gorianin, Sergei, Demotes, Jacques, Kouylekov, Milen, and Thomassen, Gard

Subjects
Life science research infrastructures, COVID-19 clinical studies, Individual Participant Data (IPD), Clinical Research Repository
Abstract

In EOSC-Life WP14, the European Clinical Research Infrastructure Network (ECRIN) has partnered with the University of Oslo (UiO) in order to commonly design, develop, implement and operate a Clinical Research Repository for individual participant data (IPD) from COVID-19 clinical studies that is compliant with European regulations and in particular with the GDPR. The functionality of the repository is split between two main systems – the service for sensitive data (TSD) infrastructure managed by the UiO on the one hand and a Repository Management System (RMS) developed by ECRIN, on the other. The TSD is used for the secure storage, access and reuse of controlled-access data objects (e.g. datasets). The RMS is designed to support and record the workflows associated with managing the repository and its interactions with data object providers, users, and requesters. The first chapter of this report provides an introduction to the Clinical Research Repository, the actors involved, and the two main processes that it supports: the Data Transfer Process (when clinical study material is provided to the repository) and the Data Use Process (when clinical study material is accessed for secondary use). Terms around the operations of the repository such as “data object”, “provider” and “secondary user” are defined to facilitate the further reading of the report. The second chapter describes the steps followed for evaluating the usability and user satisfaction of the Clinical Research Repository. Usability is defined as “the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use”. User satisfaction is part of the usability of a system and can be defined as “a measure of how well a product or system meets the needs and expectations of its users, as well as how positively users feel about their overall experience with the product or system”. To evaluate the usability and user satisfaction of the repository, two workshops were organised on the 14th and 15th of March 2023 with a small group of potential users (n=13). As part of the workshops, the participants tested the alpha version of the repository and completed a usability and user satisfaction survey. Overall, the respondents of the survey appreciated the Clinical Research Repository as a tool to facilitate clinical research data sharing and reuse. Usability scores according to the UMUX-LITE and SUS standards are provided. The respondents also raised points for improvement that are being addressed for the beta version of the tool in order to increase its usability and user satisfaction. The third chapter details the requirements for the maintenance and sustainability of the Clinical Research Repository, taking into account the needs of both the RMS and the TSD. The cost estimations include needs in software, hardware, and personnel (e.g. for the repository manager, for developers, for legal support with contracts). In an effort to be precise, estimations are provided for a short-term, a mid-term and a longer-term period. Possible funding models for the repository are discussed. Beyond the EOSC-Life project, the repository’s short-term sustainability has been secured via follow-up grants; however, for the longer-term sustainability plan to be translated into a concrete reality, extensive discussions will be needed with relevant stakeholders following the public launch of the repository.&nbsp

Published
2023
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10. Implementation of a centralized pharmacovigilance system in academic pan-European clinical trials: Experience from EU-Response and conect4children consortia

Author

Terzić, Vida, Levoyer, Léa, Figarella, Mélanie, Bigagli, Elisabetta, Mercier, Noémie, De Gastines, Lucie, Gibowski, Séverine, Trøseid, Marius, Demotes, Jacques, Olsen, Inge Christoffer, Hites, Maya, Ader, Florence, Lopez, José Ramón Arribas, Mentré, France, Espérou, Hélène, Costagliola, Dominique, Røttingen, John-Arne, Poissy, Julien, Rozé, Jean-Christophe, Warris, Adilia, O'Leary, Jackie, Fernandes, Ricardo M, Assoumou, Lambert, Hankard, Regis, Turner, Mark A, Yazdanpanah, Yazdan, Diallo, Alpha, EU-Response safety group, c4c safety group, University of Zurich, and Diallo, Alpha

Subjects
3004 Pharmacology, 2736 Pharmacology (medical), 610 Medicine & health, 10027 Clinic for Neonatology
Published
2023

11. PedCRIN tool for the biosamples management in paediatric clinical trials

Author

Giannuzzi, Viviana, primary, Ruggieri, Lucia, additional, Conte, Rosa, additional, Manfredi, Cristina, additional, Felisi, Mariagrazia, additional, Kubiak, Christine, additional, Matei, Mihaela, additional, Malik, Salma, additional, Demotes, Jacques, additional, Ceci, Adriana, additional, and Bonifazi, Donato, additional

Published
2023
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12. Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials: Experience from EU‐Response and conect4children consortia

Author

Terzić, Vida, primary, Levoyer, Léa, additional, Figarella, Mélanie, additional, Bigagli, Elisabetta, additional, Mercier, Noémie, additional, De Gastines, Lucie, additional, Gibowski, Séverine, additional, Trøseid, Marius, additional, Demotes, Jacques, additional, Olsen, Inge Christoffer, additional, Hites, Maya, additional, Ader, Florence, additional, Lopez, José Ramón Arribas, additional, Mentré, France, additional, Espérou, Hélène, additional, Costagliola, Dominique, additional, Røttingen, John‐Arne, additional, Poissy, Julien, additional, Rozé, Jean‐Christophe, additional, Warris, Adilia, additional, O'Leary, Jackie, additional, Fernandes, Ricardo M., additional, Assoumou, Lambert, additional, Hankard, Regis, additional, Turner, Mark A., additional, Yazdanpanah, Yazdan, additional, and Diallo, Alpha, additional

Published
2023
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13. Centre for Statistical and Methodological Excellence (CESAME): A Consortium Initiative for Improving Methodology in Randomised Clinical Trials

Author

Jørgensen, Caroline Kamp, primary, Olsen, Markus Harboe, additional, Nielsen, Niklas, additional, Lange, Theis, additional, Mbuagbaw, Lawrence, additional, Thabane, Lehana, additional, Billot, Laurent, additional, Binder, Nadine, additional, Garattini, Silvio, additional, Banzi, Rita, additional, Demotes, Jacques, additional, Biagioli, Elena, additional, Rulli, Eliana, additional, Bertolini, Guido, additional, Nattino, Giovanni, additional, Mathiesen, Ole, additional, Torri, Valter, additional, Gluud, Christian, additional, and Jakobsen, Janus Christian, additional

Published
2023
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14. Quelle stratégie française dans le cadre H2020 ?

Author

Dhainaut, Jean-François, Bassompierre, François, Misse, Christophe, Diebolt, Vincent, Pouletty-Lefèbvre, Brigitte, Baker, Angela, Borel, Thomas, Braunstein, David, Demotes, Jacques, François, Bruno, Huet, Stéphane, Micallef, Joëlle, Molon, Annamaria, Rascol, Olivier, Ravoire, Sophie, Schwartz, Bertrand, Donne, de Nathalie, Fusaï, Guillaume, Pouletty, Philippe, and Vicaut, Eric

Published
2015
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15. What Strategy Should France Implement for H2020?

Author

Dhainaut, Jean-François, Bassompierre, François, Misse, Christophe, Diebolt, Vincent, Pouletty-Lefèbvre, Brigitte, Baker, Angela, Borel, Thomas, Braunstein, David, Demotes, Jacques, François, Bruno, Huet, Stéphane, Micallef, Joëlle, Molon, Annamaria, Rascol, Olivier, Ravoire, Sophie, Schwartz, Bertrand, Donne, Nathalie, Fusaï, Guillaume, Pouletty, Philippe, and Vicaut, Eric

Published
2015
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16. Implementation of a Centralized Pharmacovigilance System in Multi-Country European Clinical Trials: Points to Consider for Academic Sponsors and Lessons Learnt from EU-Response and Connect4Children Consortia

Author

Terzić, Vida, primary, Levoyer, Léa, additional, Figarella, Mélanie, additional, Bigagli, Elisabetta, additional, Mercier, Noémie, additional, Gastines, Lucie de, additional, Gibowski, Severine, additional, Trøseid, Marius, additional, Demotes, Jacques, additional, Olsen, Inge, additional, Hites, Maya, additional, Ader, Florence, additional, Lopez, José Arribas, additional, Mentré, France, additional, Espérou, Hélèhe, additional, Costagliola, Dominique, additional, Røttingen, John-Arne, additional, Poissy, Julien, additional, Rozé, Jean-Christophe, additional, Warris, Adilia, additional, O'Leary, Jackie, additional, Fernandes, Ricardo, additional, Assoumou, Lambert, additional, Hankard, Régis, additional, Turner, Mark, additional, Yazdanpanah, Yazdan, additional, and Diallo, Alpha, additional

Published
2022
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17. EOSC-Life Public database inventorying the national health databases and registries and describing their access procedures for reuse for research purposes

Author

Panagiotopoulou, Maria, Yaïche, Sarhan, Michon, Amélie, Ohmann, Christian, Demotes, Jacques, Matei, Mihaela, Canham, Steve, Hjelle, Sigrun Margrethe, Klusek, Patrycja, Batuca, Joana, Schmid, Caecilia, Buoncervello, Maria, Toschi, Elena, Minghetti, Luisa, Chiusano, Maria Luisa, Vives Vilatersana, Adriana, Calvo I Orteu, María, Szabó, Zsolt, Součková, Lenka, Noskova, Kristyna, Kappala, Sharon, Creely, Caitriona, Ward, Oonagh, Keane, Fionnuala, Klammt, Sebastian, Boiten, Jan-Willem, Adeniran, Ayodeji, Mayrhofer, Michaela Th., and Sonderlichová, Simona

Subjects
Health data reuse for research purposes, Life science research infrastructures, Health data registries, Health data bases
Abstract

The digitisation of healthcare has brought new opportunities to complement and enhance the data traditionally utilized in regulatory decision-making. According to the EMA, real world evidence (RWE) has been defined as the information derived from analysis of routinely collected real world data (RWD) relating to a patient’s health status or the delivery of healthcare from a variety of sources other than traditional clinical trials. Before fostering the enormous potential presented by the use of routinely collected RWD (e.g. electronic health records, medical claims, insurance data etc.) several challenges need to be addressed: operational, technical, methodological and ELSI. Reusing RWD for research purposes in Europe and especially in a crossborder manner is hampered by the fact that health databases and registries are not easily discoverable and, even when they are, understanding what data they contain and their suitability for addressing a specific research question remains not trivial due to the lack of detailed data catalogues with adequate metadata (especially in English). The present report is entitled “D4.5 Public database inventorying the national health databases and registries and describing their access procedures for reuse for research purposes”. As the title indicates, the report delivers an inventory of national health databases and registries covering 15 European countries: Austria, Czech Republic, France, Germany, Hungary, Ireland, Italy, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland. For each country the reader can find information on the national healthcare system, a list of health databases and registries, their description (or links to websites where this description can be found) and information on data access for research purposes. Although this deliverable was initially conceived as a “public database” in the form of a website, the EOSC-Life WP4 partners agreed that this would be unnecessary as the European Health Information Portal1 is already playing this role. Instead, this report will become publicly available through Zenodo and disseminated to relevant stakeholders working on similar issues (including the actors behind the Health Information Portal) as a way to “join forces” and complement each other’s work instead of duplicating efforts. In summary, we conclude that the picture across Europe is diverse and at times patchy as the health databases and registries are subject to different governance and sustainability models but also to different local laws and access rules. Interestingly, there is still, on a European level, great debate around the terms “anonymisation”, “pseudonymisation” and “de-identification” and when data can be considered anonymised and as such exempted from the GDPR. Additionally, even when the current barriers of discoverability and accessibility (that are the main focus of this report) are lifted, there remains the major question of whether such data sources are suitable for research, as concerns around their quality, completeness and structure (or lack of) are still to be addressed.

Published
2022

18. EOSC-Life Report about technical implementation and validation of the COVID-19 portal

Author

Canham, Steve, Gorianin, Sergey, Kouylekov, Milen, Panagiotopoulou, Maria, Ohmann, Christian, Kichenassamy, Swarnalathaa, Thomassen, Gard, Fugelli, Pål, and Demotes, Jacques

Subjects
clinical research repository, COVID-19, GDPR compliant data sharing, individual participant data
Abstract

The present report is focused on the technical implementation and validation of the COVID-19 clinical research repository developed within the EOSC-Life project. The first section describes the functionality of the repository, split between its two main systems - the TSD infrastructure on the one hand, operated by the University of Oslo, and the Repository Management System (RMS), developed by ECRIN, on the other hand. The RMS is designed to support and record the workflows associated with managing the repository and its interactions with providers, secondary users and requesters. Subsequently, the two systems and their interface to support the repository’s activity are described in detail, including the AAI infrastructure that will be used and shared by both the RMS and the TSD. Finally, the validation strategy that is currently applied to the RMS and to the new, repository-specific elements of the TSD is outlined.

Published
2022

20. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

Author

Diallo, Alpha Troseid, Marius Simensen, Victoria Charlotte and Boston, Anais Demotes, Jacques Olsen, Inge Christoffer and Chung, Florence Paiva, Jose Artur Hites, Maya Ader, Florence and Arribas, Jose Ramon Baratt-Due, Andreas Melien, Oyvind and Tacconelli, Evelina Staub, Therese Greil, Richard Tsiodras, Sotirios Briel, Matthias Esperou, Helene Mentre, France and Eustace, Joe Saillard, Juliette Delmas, Christelle LeMestre, Soizic Dumousseaux, Marina Costagliola, Dominique Rottingen, John-Arne Yazdanpanah, Yazdan EU-Response Investigators Grp

Published
2022

21. Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group

Author

Diallo, Alpha, Trøseid, Marius, Simensen, Victoria Charlotte, Boston, Anaïs, Demotes, Jacques, Olsen, Inge Christoffer, Chung, Florence, Paiva, José Artur, Hites, Maya, Ader, Florence, Arribas, Jose Ramon, Baratt-Due, Andreas, Melien, Øyvind, Tacconelli, Evelina, Staub, Thèrèse, Greil, Richard, Tsiodras, Sotirios, Briel, Matthias, Esperou, Hélène, Mentré, France, Eustace, Joe, Saillard, Juliette, Delmas, Christelle, LeMestre, Soizic, Dumousseaux, Marina, Costagliola, Dominique, Røttingen, John-Arne, and Yazdanpanah, Yazdan

Published
2022
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22. Breaking down the barriers of academic multinational trials.

Author

Demotes, Jacques and Esdaile, Martina

Subjects
*INFRASTRUCTURE (Economics), *SCIENTIFIC community, *RESEARCH personnel, *REGULATORY approval, *CLINICAL trials
Abstract

The article discusses the challenges and benefits of conducting multinational clinical trials in the academic research setting. While most industry-sponsored trials are multinational, the majority of investigator-initiated trials are conducted in a single country. The article highlights the barriers that researchers face when planning multinational trials, such as differing regulatory and ethical approvals, language diversity, and funding availability. To support academic researchers in conducting multinational trials, the European Clinical Research Infrastructure Network (ECRIN) was created. ECRIN provides support in planning, design, and implementation of trials, as well as advocating for the academic research community and developing tools to facilitate cross-border collaboration. [Extracted from the article]

Published
2023

24. EOSC-Life WP14: COVID-19 Repository Data Sharing Policy

Author

Ohmann, Christian, Matei, Mihaela, Canham, Steve, Panagiotopoulou, Maria, Demotes, Jacques, Thomassen, Gard, and Blomberg, Niklas

Subjects
clinical trials, repository, data sharing, COVID-19
Abstract

EOSC-Life is a 4-year project funded under the European Union’s Horizon 2020 programme. Itaims to bring together the 13 Research Infrastructures in the Health and Food domain of the ESFRI Roadmap to create an open, collaborative digital space for life sciences in the European Open Science Cloud (EOSC).In March 2020, after the COVID-19 pandemic outbreak and as a rapid response to it EOSC-Life added to its work plan two new work packages to help tackle the pandemic.In EOSC-Life WP14, the European Clinical Research Infrastructure Network (ECRIN, https://ecrin.org/) has partnered with the University of Oslo (UiO, https://www.uio.no/english/) in order to commonly design, develop, implement and operate a repository for individual participant data (IPD) from COVID-19 clinical research studies that is compliant with European regulations and in particular with the GDPR.For the storage of the IPD, the TSD infrastructure of the University of Oslo will be used, which is a multitenant remote access system with a strong set of built-in security measures. The present document highlights the Data Sharing Policy of the COVID-19 repository under development in EOSC-Life WP14.A model Data Transfer Agreement for further discussions with Data Object Providers can also be madeavailable on request (contact maria.panagiotopoulou@ecrin.org). &nbsp

Published
2021
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26. Biomarker discovery studies for patient stratification using machine learning analysis of omics data: a scoping review

Author

Glaab, Enrico, Rauschenberger, Armin, Banzi, Rita, Gerardi, Chiara, Garcia, Paula, Demotes, Jacques, PERMIT group, EU Horizon 2020 [sponsor], and Luxembourg Centre for Systems Biomedicine (LCSB): Biomedical Data Science (Glaab Group) [research center]

Subjects
Multidisciplinaire, généralités & autres [D99] [Sciences de la santé humaine], biomarkers, articificial intelligence, prediction, personalized medicine, patient stratification, omics, statistical learning, machine learning, classification, regression, scoping review, clinical validation, Multidisciplinary, general & others [D99] [Human health sciences]
Abstract

Objective: To review biomarker discovery studies using omics data for patient stratification which led to clinically validated FDA-cleared tests or laboratory developed tests, in order to identify common characteristics and derive recommendations for future biomarker projects. Design: Scoping review. Methods: We searched PubMed, EMBASE and Web of Science to obtain a comprehensive list of articles from the biomedical literature published between January 2000 and July 2021, describing clinically validated biomarker signatures for patient stratification, derived using statistical learning approaches. All documents were screened to retain only peer-reviewed research articles, review articles or opinion articles, covering supervised and unsupervised machine learning applications for omics-based patient stratification. Two reviewers independently confirmed the eligibility. Disagreements were solved by consensus. We focused the final analysis on omics-based biomarkers which achieved the highest level of validation, that is, clinical approval of the developed molecular signature as a laboratory developed test or FDA approved tests. Results: Overall, 352 articles fulfilled the eligibility criteria. The analysis of validated biomarker signatures identified multiple common methodological and practical features that may explain the successful test development and guide future biomarker projects. These include study design choices to ensure sufficient statistical power for model building and external testing, suitable combinations of non-targeted and targeted measurement technologies, the integration of prior biological knowledge, strict filtering and inclusion/exclusion criteria, and the adequacy of statistical and machine learning methods for discovery and validation. Conclusions: While most clinically validated biomarker models derived from omics data have been developed for personalised oncology, first applications for non-cancer diseases show the potential of multivariate omics biomarker design for other complex disorders. Distinctive characteristics of prior success stories, such as early filtering and robust discovery approaches, continuous improvements in assay design and experimental measurement technology, and rigorous multicohort validation approaches, enable the derivation of specific recommendations for future studies.

Published
2021

27. EOSC-Life Strategic plan for the development of a COVID-19 repository including specification of technical requirements, policies and procedures

Author

Canham, Steve, Ohmann, Christian, Thomassen, Gard, Matei, Mihaela, Demotes, Jacques, and Panagiotopoulou, Maria

Subjects
COVID-19, Ethical, legal requirements, Individual Participant Data repository
Abstract

The deliverable highlights the necessity of data sharing in the context of the COVID-19 pandemic and provides a “high level” concept document for the design, development, implementation and use of a repository for Individual Participant Data (IPD) from COVID-19 clinical trials. In the following pages, the most important aspects for setting-up and operating the repository such as legal challenges, functional specifications, quality assurance, implementation plan, sustainability and governance, evaluation of routine use, outreach, partnerships and scalability are discussed in detail.&nbsp

Published
2020

28. EOSC-Life Strategic plan for the development of a COVID-19 repository including specification of technical requirements, policies and procedures - v2

Author

Canham, Steve, Ohmann, Christian, Thomassen, Gard, Matei, Mihaela, Demotes, Jacques, and Panagiotopoulou, Maria

Subjects
COVID-19, Ethical, legal requirements, Individual Participant Data repository
Abstract

The deliverable highlights the necessity of data sharing in the context of the COVID-19 pandemic and provides a “high level” concept document for the design, development, implementation and use of a repository for Individual Participant Data (IPD) from COVID-19 clinical trials. In the following pages, the most important aspects for setting-up and operating the repository such as legal challenges, functional specifications, quality assurance, implementation plan, sustainability and governance, evaluation of routine use, outreach, partnerships and scalability are discussed in detail.&nbsp

Published
2020

29. EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke

Author

van der Worp, Bart H., Macleod, Malcolm R., Bath, Philip M. W., Demotes, Jacques, Durand-Zaleski, Isabelle, Gebhardt, Bernd, Gluud, Christian, Kollmar, Rainer, Krieger, Derk W., Lees, Kennedy R., Molina, Carlos, Montaner, Joan, Roine, Risto O., Petersson, Jesper, Staykov, Dimitre, Szabo, Istvan, Wardlaw, Joanna M., and Schwab, Stefan

Published
2014
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30. Biomarker Research and Development for Coronavirus Disease 2019 (COVID-19): European Medical Research Infrastructures Call for Global Coordination

Author

Oldoni, Emanuela, primary, van Gool, Alain, additional, García Bermejo, Laura, additional, Scherer, Andreas, additional, Mayrhofer, Michaela Th, additional, Florindi, Francesco, additional, Demotes, Jacques, additional, Kubiak, Christine, additional, Fauvel, Anne-Charlotte, additional, Bietrix, Florence, additional, Ussi, Anton, additional, and Andreu, Antonio L, additional

Published
2020
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31. Investigator initiated clinical trials (IICTs): a systematic search in registries comparing Czech Republic and Portugal in terms of funding policies and scientific outcomes

Author

Madeira, Catarina, primary, Hořavová, Lenka, additional, Santos, Francisco dos, additional, Batuca, Joana, additional, Nebeska, Katerina, additional, Souckova, Lenka, additional, Kubiak, Christine, additional, Demotes, Jacques, additional, Demlová, Regina, additional, and Monteiro, Emília Carreira, additional

Published
2020
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34. Transparency and accuracy in funding investigator-initiated clinical trials

Author

Madeira, Catarina, Santos, Francisco, Kubiak, Christine, Demotes, Jacques, Monteiro, Emília Carreira, NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM), and Centro de Estudos de Doenças Crónicas (CEDOC)

Subjects
Medicine(all), clinical trials, investigator-initiated clinical trials, clinical trials registry, clinical trials database, health care economics and organizations, interventional clinical studies
Abstract

Objectives This study aims to identify the sources of funding for investigator-initiated clinical trials (IICTs) in Portugal, and to recommend ways to improve the quality of information collected from clinical trial databases about funding. Design and methods A systematic search of trial registrations over the last 13 years - using the WHO International Clinical Trials Registry Platform (WHO-ICTRP) and four clinical trials registries (CTRs) - was carried out to identify IICTs in Portugal, used as a case study. Data from the databases were compared with data contained in publications to evaluate the consistency of information on funding sources. The term a € database' is used in this study to refer to both the WHO-ICTRP and the CTRs. When mentioned separately, the WHO-ICTRP is referred to as a a € platform', while the CTRs are referred to as a € registries'. Outcome Suggestions to improve clinical trials databases to clearly identify the funding sources and data ownership in IICTs. Results Two hundred and eighty-two IICTs were identified in Portugal. Twenty per cent of trials were supported by industry with unclear information on the ownership of the results. Inaccuracy was found in the information about sponsors and funders. The information about funding in all resulting publications (77 out of 133 completed studies) was also inconsistent between databases in 35 out of 77 (45%) of the studies. Notably, 23% of the trials funded by non-profit organisations (n=226) received funds from international and/or national funding agencies. Conclusions Identification of IICT funding and ownership of results is unclear in the databases used for this study, which may lead to misunderstandings about the independence of the obtained results. Transparency and accuracy are desirable so that public decision makers and strategic partners can accurately evaluate national performance in this particular type of clinical research. publishersversion published

Published
2019

35. Biomarker Research and Development for Coronavirus Disease 2019 (COVID-19): European Medical Research Infrastructures Call for Global Coordination.

Author

Oldoni, Emanuela, Gool, Alain van, Bermejo, Laura García, Scherer, Andreas, Mayrhofer, Michaela Th, Florindi, Francesco, Demotes, Jacques, Kubiak, Christine, Fauvel, Anne-Charlotte, Bietrix, Florence, Ussi, Anton, and Andreu, Antonio L

Subjects
BIOMARKERS, RESEARCH, WORLD health, CONCEPTUAL structures, INTERPROFESSIONAL relations, COVID-19 testing, COVID-19 pandemic
Abstract

An effective response to the coronavirus disease 2019 (COVID-19) pandemic requires a better understanding of the biology of the infection and the identification of validated biomarker profiles that would increase the availability, accuracy, and speed of COVID-19 testing. Here, we describe the strategic objectives and action lines of the European Alliance of Medical Research Infrastructures (AMRI), established to improve the research process and tackle challenges related to diagnostic tests and biomarker development. Recommendations include: the creation of a European taskforce for validation of novel diagnostic products, the definition and promotion of criteria for COVID-19 samples biobanking, the identification and validation of biomarkers as clinical endpoints for clinical trials, and the definition of immune biomarker signatures at different stages of the disease. An effective management of the COVID-19 pandemic is possible only if there is a high level of knowledge and coordination between the public and private sectors within a robust quality framework. [ABSTRACT FROM AUTHOR]

Published
2021
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37. The Global academic research organization network: Data sharing to cure diseases and enable learning health systems

Author

Fukushima, Masanori, primary, Austin, Christopher, additional, Sato, Norihiro, additional, Maruyama, Tatsuya, additional, Navarro, Eileen, additional, Rocca, Mitra, additional, Demotes, Jacques, additional, Haendel, Melissa, additional, Volchenboum, Samuel L., additional, Cowperthwaite, Matthew, additional, Silverstein, Jonathan C., additional, Webb, Chris, additional, Sim, Ida, additional, Chase, Marianne, additional, Speakman, John, additional, Augustine, Erika, additional, Ford, Daniel E., additional, and Kush, Rebecca, additional

Published
2018
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38. Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries

Author

de Andres Fernando, Serrano Mariantonia, Schieppati Arrigo, Gaynor Siobhan, Cooney Margaret, O'Brien Timothy, Kardos Gabriella, Blasko Gyorgy, Temesvari Zsuza, Strenge-Hesse Anke, Kuchinke Wolfgang, Geismann Sebastian, Dreier Gabriele, Grählert Xina, Stankovski Lea, Kubiak Christine, Barraud Béatrice, Libersa Christian, Thirstrup Steffen, Winter Diana, Huemer Karl-Heinz, Whitfield Kate, Sanz Nuria, Hernández Raquel, Kreis Germán, Asker-Hagelberg Charlotte, Johansson Hanna, Asghar Adeeba, Husson Jean-Marc, Demotes Jacques, and Gluud Christian

Subjects
Medicine (General), R5-920
Abstract

Abstract Background 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries. Methods The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK). Results European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount. Conclusions 'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.

Published
2010
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39. CORBEL Core set of outcome measures for clinical trials for each disease condition

Author

Battaglia, Serena, Da Silva-Buttkus, Patricia, Demotes, Jacques, Fuchs, Helmut, Gailus-Durner, Valérie, Garattini, Silvio, Harman, Nicola, Prinsen, Cecilia, Raess, Michael, Terwee, Caroline, and Williamson, Paula

Subjects
Phenotyping, Clinical outcome measures, 3. Good health, Animal models
Abstract

Animal models play a crucial role in understanding the mechanisms of diseases and symptoms, and to test the efficacy and safety of treatments before conducting clinical trials. Selecting human diseases and developing core sets of clinical outcome measures as well as complementary sets of mouse phenotyping measures will contribute to narrow the gap between animal models and human trials.

Published
2017
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40. Evaluation of non-invasive biomarkers of kidney allograft rejection in a prospective multicenter unselected cohort study (EU-TRAIN)

Author

Goutaudier, Valentin, Danger, Richard, Catar, Rusan Ali, Racapé, Maud, Philippe, Aurélie, Elias, Michelle, Raynaud, Marc, Aubert, Olivier, Bouton, Didier, Girardin, François, Vicaut, Éric, Yaiche, Sarhan, Demotes, Jacques, Heidecke, Harald, Taupin, Jean-Luc, Randoux-Lebrun, Christine, Zaidan, Mohamad, Papuchon, Emmanuelle, Le Mai, Hoa, Nguyen, Thi-Van-Ha, Moreso, Francesc, Berney, Thierry, Villard, Jean, Legendre, Christophe, Dragun, Duska, Papalois, Vassilios, Potena, Luciano, Giral, Magali, Gourraud, Pierre-Antoine, Brouard, Sophie, Crespo, Elena, Halleck, Fabian, Budde, Klemens, Bestard, Oriol, Loupy, Alexandre, and Lefaucheur, Carmen

Abstract

Non-invasive biomarkers are promising tools for improving kidney allograft rejection monitoring, but their clinical adoption requires more evidence in specifically designed studies. To address this unmet need, we designed the EU-TRAIN study, a large prospective multicentric unselected cohort funded by the European Commission. Here, we included consecutive adult patients who received a kidney allograft in nine European transplant centers between November 2018 and June 2020. We prospectively assessed gene expression levels of 19 blood messenger RNAs, four antibodies targeting non-human leukocyte antigen (HLA) endothelial antigens, together with circulating anti-HLA donor-specific antibodies (DSA). The primary outcome was allograft rejection (antibody-mediated, T cell-mediated, or mixed) in the first year post-transplantation. Overall, 412 patients were included, with 812 biopsies paired with a blood sample. CD4gene expression was significantly associated with rejection, while circulating anti-HLA DSA had a significant association with allograft rejection and a strong association with antibody-mediated rejection. All other tested biomarkers, including AKR1C3, CD3E, CD40, CD8A, CD9, CTLA4, ENTPD1, FOXP3, GZMB, ID3, IL7R, MS4A1, MZB1, POU2AF1, POU2F1, TCL1A, TLR4, and TRIB1, as well as antibodies against angiotensin II type 1 receptor, endothelin 1 type A receptor, C3a and C5a receptors, did not show significant associations with allograft rejection. The blood messenger RNAs and non-HLA antibodies did not show an additional value beyond standard of care monitoring parameters and circulating anti-HLA DSA to predict allograft rejection in the first year post-transplantation. Thus, our results open avenues for specifically designed studies to demonstrate the clinical relevance and implementation of other candidate non-invasive biomarkers in kidney transplantation practice.

Published
2024
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41. PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke. Rationale and design of a randomised, open, phase III, clinical trial with blinded outcome assessment

Author

Reinink, Hendrik, primary, de Jonge, Jeroen C, additional, Bath, Philip M, additional, van de Beek, Diederik, additional, Berge, Eivind, additional, Borregaard, Saskia, additional, Ciccone, Alfonso, additional, Csiba, Laszlo, additional, Demotes, Jacques, additional, Dippel, Diederik W, additional, Kõrv, Janika, additional, Kurkowska-Jastrzebska, Iwona, additional, Lees, Kennedy R, additional, Macleod, Malcolm R, additional, Ntaios, George, additional, Randall, Gary, additional, Thomalla, Götz, additional, and van der Worp, H Bart, additional

Published
2018
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42. Viva Europa, a Land of Excellence in Research and Innovation for Health and Wellbeing

Author

Auffray, Charles, primary, Sagner, Michael, additional, Abdelhak, Sonia, additional, Adcock, Ian, additional, Agusti, Alvar, additional, Amaral, Margarida, additional, Antonarakis, Stylianos, additional, Arena, Ross, additional, Argoul, Françoise, additional, Balling, Rudi, additional, Barabasi, Albert-Laszlo, additional, Beckmann, Jacques, additional, Bjartell, Anders, additional, Blomberg, Niklas, additional, Bourgeron, Thomas, additional, Boutron, Bertrand, additional, Brahmachari, Samir, additional, Bréchot, Christian, additional, Brightling, Christopher, additional, Cascante, Marta, additional, Cesario, Alfredo, additional, Charron, Dominique, additional, Chen, Sai-Juan, additional, Chen, Zhu, additional, Chung, Fan, additional, Clément, Karine, additional, Conesa, Ana, additional, Cozzone, Alain, additional, de Jong, Menno, additional, Deleuze, Jean-François, additional, Demotes, Jacques, additional, di Meglio, Alberto, additional, Djukanovic, Ratko, additional, Dogrusoz, Ugur, additional, Epel, Elissa, additional, Fischer, Alain, additional, Gelemanovic, Andrea, additional, Goble, Carole, additional, Gojobori, Takashi, additional, Goldman, Michel, additional, Goossens, Herman, additional, Gros, François, additional, Guo, Yi-Ke, additional, Hainaut, Pierre, additional, Harrison, David, additional, Hoffmann, Hans, additional, Hood, Leroy, additional, Hunter, Peter, additional, Jacob, Yves, additional, Kitano, Hiroaki, additional, Klingmüller, Ursula, additional, Knoppers, Bartha, additional, Kolch, Walter, additional, Koopmans, Marion, additional, Lancet, Doron, additional, Laville, Martine, additional, Lehn, Jean-Marie, additional, Lévi, Francis, additional, Lisistsa, Andrey, additional, Lotteau, Vincent, additional, Magnan, Antoine, additional, Mayosi, Bongani, additional, Metspalu, Andres, additional, Moreau, Yves, additional, N’Dow, James, additional, Nicod, Laurent, additional, Noble, Denis, additional, Manuela Nogueira, Maria, additional, Norrby-Teglund, Anna, additional, Nottale, Laurent, additional, Openshaw, Peter, additional, Oztürk, Mehmet, additional, Palkonen, Susanna, additional, Parodi, Silvio, additional, Pellet, Johann, additional, Polasek, Ozren, additional, Price, Nathan, additional, Pristipino, Christian, additional, Radstake, Timothy, additional, Raes, Martine, additional, Roca, Josep, additional, Rozman, Damjana, additional, Sabatier, Philippe, additional, Sasson, Shlomo, additional, Schmeck, Bernd, additional, Serageldin, Ismaïl, additional, Simonds, Anita, additional, Soares, Bento, additional, Sterk, Peter, additional, Superti-Furga, Giulio, additional, Supple, David, additional, Tegner, Jesper, additional, Uhlen, Mathias, additional, van der Werf, Sylvie, additional, Villoslada, Pablo, additional, Vinciguerra, Manlio, additional, Volpert, Vitaly, additional, Webb, Steve, additional, Wouters, Emiel, additional, Sanz, Ferran, additional, and Nobrega, Francisco, additional

Published
2017
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46. A European approach to clinical investigator training

Author

Boeynaems, Jean-Marie, primary, Canivet, Cindy, additional, Chan, Anthony, additional, Clarke, Mary J., additional, Cornu, Catherine, additional, Daemen, Esther, additional, Demotes, Jacques, additional, Nys, Katelijne De, additional, Hirst, Barry, additional, Hundt, Ferdinand, additional, Kassai, Behrouz, additional, Kerpel-Fronius, Sandor, additional, Kiessig, Lucy, additional, Klech, Heinrich, additional, Kraehenbuhl, Jean-Pierre, additional, Lafolie, Pierre, additional, Lucht, Martin, additional, Niese, Detlef, additional, Pauli-Magnus, Christiane, additional, Peters, Barbara, additional, Schaltenbrand, Ralf, additional, Stockis, Armel, additional, Stykova, Martina, additional, Verheus, Nicolette, additional, and Klingmann, Ingrid, additional

Published
2013
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47. Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries

Author

Whitfield, Kate, primary, Huemer, Karl-Heinz, additional, Winter, Diana, additional, Thirstrup, Steffen, additional, Libersa, Christian, additional, Barraud, Béatrice, additional, Kubiak, Christine, additional, Stankovski, Lea, additional, Grählert, Xina, additional, Dreier, Gabriele, additional, Geismann, Sebastian, additional, Kuchinke, Wolfgang, additional, Strenge-Hesse, Anke, additional, Temesvari, Zsuza, additional, Blasko, Gyorgy, additional, Kardos, Gabriella, additional, O'Brien, Timothy, additional, Cooney, Margaret, additional, Gaynor, Siobhan, additional, Schieppati, Arrigo, additional, Serrano, Mariantonia, additional, de Andres, Fernando, additional, Sanz, Nuria, additional, Hernández, Raquel, additional, Kreis, Germán, additional, Asker-Hagelberg, Charlotte, additional, Johansson, Hanna, additional, Asghar, Adeeba, additional, Husson, Jean-Marc, additional, Demotes, Jacques, additional, and Gluud, Christian, additional

Published
2010
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48. Euro HYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke.

Author

Worp, H. Bart, Macleod, Malcolm R., Bath, Philip M. W., Demotes, Jacques, Durand-Zaleski, Isabelle, Gebhardt, Bernd, Gluud, Christian, Kollmar, Rainer, Krieger, Derk W., Lees, Kennedy R., Molina, Carlos, Montaner, Joan, Roine, Risto O., Petersson, Jesper, Staykov, Dimitre, Szabo, Istvan, Wardlaw, Joanna M., and Schwab, Stefan

Subjects
THERAPEUTIC hypothermia, CLINICAL trials, STROKE treatment, BRAIN injuries, CARDIAC arrest, HEALTH outcome assessment
Abstract

Rationale Cooling reduced infarct size and improved neurological outcomes in animal studies modeling ischemic stroke, and also improved outcome in randomized clinical trials in patients with hypoxic-ischemic brain injury after cardiac arrest. Cooling awake patients with ischemic stroke has been shown feasible in phase II clinical trials. Primary aim To determine whether systemic cooling to a target body temperature between 34·0 and 35·0°C, started within six-hours of symptom onset and maintained for 24 h, improves functional outcome at three-months in patients with acute ischemic stroke. Design International, multicenter, phase III, randomized, open-label clinical trial with blinded outcome assessment in 1500 patients aged 18 years or older with acute ischemic stroke and a National Institutes of Health Stroke Scale score of 6 up to and including 18. In patients randomized to hypothermia, cooling to a target body temperature of 34-35°C will be started within six-hours after symptom onset with rapid intravenous infusion of refrigerated normal saline or a surface cooling technique and maintained for 24 h with a surface or endovascular technique. Patients randomized to hypothermia will receive pethidine and buspirone to prevent shivering and discomfort. Primary outcome Score on the modified Rankin Scale at 91 days, as analyzed with ordinal logistic regression and expressed as a common odds ratio. Discussion With 750 patients per intervention group, this trial has 90% power to detect 7% absolute improvement at the 5% significance level. The full trial protocol is available at . Identifier: NCT01833312. [ABSTRACT FROM AUTHOR]

Published
2014
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49. Plateform trials

Author

Roustit, Matthieu, Demarcq, Olivier, Laporte, Silvy, Barthélemy, Philippe, Chassany, Olivier, Cucherat, Michel, Demotes, Jacques, Diebolt, Vincent, Espérou, Hélène, Fouret, Cécile, Galaup, Ariane, Gambotti, Laetitia, Gourio, Charlotte, Guérin, Aurélie, Labruyère, Carine, Paoletti, Xavier, Porcher, Raphael, Simon, Tabassome, and Varoqueaux, Nathalie

Abstract

For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investigation. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities.

Published
2022
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50. Les essais plateformes

Author

Roustit, Matthieu, Demarcq, Olivier, Laporte, Silvy, Barthélemy, Philippe, Chassany, Olivier, Cucherat, Michel, Demotes, Jacques, Diebolt, Vincent, Espérou, Hélène, Fouret, Cécile, Galaup, Ariane, Gambotti, Laetitia, Gourio, Charlotte, Guérin, Aurélie, Labruyère, Carine, Paoletti, Xavier, Porcher, Raphael, Simon, Tabassome, and Varoqueaux, Nathalie

Abstract

Les essais plateformes connaissent depuis quelques années un essor important, amplifié récemment par la pandémie de coronavirus disease2019 (COVID-19). La mise en œuvre d’un essai plateforme s’avère particulièrement utile dans certaines pathologies, notamment lorsqu’il y a un nombre important de candidats médicaments à évaluer, une évolution rapide du traitement de référence ou dans les situations de besoin urgent d’évaluation, au cours desquelles la mutualisation des protocoles et des infrastructures permet d’optimiser le nombre de patients à inclure, les coûts et les délais de réalisation de l’investigation. Toutefois, la spécificité des essais plateformes soulève des problématiques méthodologiques, éthiques et règlementaires, qui ont fait l’objet de la table ronde et qui sont exposées dans cet article. La table ronde a également été l’occasion d’aborder la complexité de la promotion et de la gestion des données liée à la multiplicité des partenaires, le financement et la gouvernance de ces essais, et le niveau d’acceptabilité de leurs résultats par les autorités compétentes.

Published
2022
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