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1. Design Considerations for a Phase II platform trial in Major Depressive Disorder

Author

Freitag, Michaela Maria, Zocholl, Dario, Meyer, Elias Laurin, Gold, Stefan M., Roig, Marta Bofill, De Smedt, Heidi, Posch, Martin, and König, Franz

Subjects
Statistics - Applications, 62K99
Abstract

Major Depressive Disorder (MDD) is one of the most common causes of disability worldwide. Unfortunately, about one-third of patients do not benefit sufficiently from available treatments and not many new drugs have been developed in this area in recent years. We thus need better and faster ways to evaluate many different treatment options quickly. Platform trials are a possible remedy - they facilitate the evaluation of more investigational treatments in a shorter period of time by sharing controls, as well as reducing clinical trial activation and recruitment times. We discuss design considerations for a platform trial in MDD, taking into account the unique disease characteristics, and present the results of extensive simulations to investigate the operating characteristics under various realistic scenarios. To allow the testing of more treatments, interim futility analyses should be performed to eliminate treatments that have either no or negligible treatment effect. Furthermore, we investigate different randomisation and allocation strategies as well as the impact of the per-treatment arm sample size. We compare the operating characteristics of such platform trials to those of traditional randomised controlled trials and highlight the potential advantages of platform trials.

Published
2023

2. Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints

Author

Meyer, Elias Laurin, Mesenbrink, Peter, Di Prospero, Nicholas A., Pericàs, Juan M., Glimm, Ekkehard, Ratziu, Vlad, Sena, Elena, and König, Franz

Subjects
Statistics - Applications
Abstract

Non-alcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic fatty liver disease (NAFLD) and a disease with high unmet medical need. Platform trials provide great benefits for sponsors and trial participants in terms of accelerating drug development programs. In this article, we describe some of the activities of the EU-PEARL consortium (EU Patient-cEntric clinicAl tRial pLatforms) regarding the use of platform trials in NASH, in particular the proposed trial design, decision rules and simulation results. For a set of assumptions, we present the results of a simulation study recently discussed with two health authorities and the learnings from these meetings from a trial design perspective. Since the proposed design uses co-primary binary endpoints, we furthermore discuss the different options and practical considerations for simulating correlated binary endpoints.

Published
2022
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3. CohortPlat: Simulation of cohort platform trials investigating combination therapies

Author

Meyer, Elias Laurin, Mesenbrink, Peter, Dunger-Baldauf, Cornelia, Glimm, Ekkehard, and König, Franz

Subjects
Statistics - Applications
Abstract

Platform trials have gained a lot of attention recently as a possible remedy for time-consuming classical two-arm randomized controlled trials, especially in early phase drug development. This short article illustrates how to use the CohortPlat R package to simulate a cohort platform trial, where each cohort consists of a combination treatment and the respective monotherapies and standard-of-care. The endpoint is always assumed to be binary. The package offers extensive flexibility with respect to both platform trial trajectories, as well as treatment effect scenarios and decision rules. As a special feature, the package provides a designated function for running multiple such simulations efficiently in parallel and saving the results in a concise manner. Many illustrations of code usage are provided.

Published
2022

5. A meta-analysis and real-world cohort study on the sex-related differences in efficacy and safety of immunotherapy for hepatocellular carcinoma

Author

Balcar, Lorenz, Scheiner, Bernhard, Fulgenzi, Claudia Angela Maria, D’Alessio, Antonio, Pomej, Katharina, Roig, Marta Bofill, Meyer, Elias Laurin, Che, Jaekyung, Nishida, Naoshi, Lee, Pei-Chang, Wu, Linda, Ang, Celina, Krall, Anja, Saeed, Anwaar, Stefanini, Bernardo, Cammarota, Antonella, Pressiani, Tiziana, Abugabal, Yehia I., Chamseddine, Shadi, Wietharn, Brooke, Parisi, Alessandro, Huang, Yi-Hsiang, Phen, Samuel, Vivaldi, Caterina, Salani, Francesca, Masi, Gianluca, Bettinger, Dominik, Vogel, Arndt, von Felden, Johann, Schulze, Kornelius, Silletta, Marianna, Trauner, Michael, Samson, Adel, Wege, Henning, Piscaglia, Fabio, Galle, Peter R., Stauber, Rudolf, Kudo, Masatoshi, Singal, Amit G., Itani, Aleena, Ulahannan, Susanna V., Parikh, Neehar D., Cortellini, Alessio, Kaseb, Ahmed, Rimassa, Lorenza, Chon, Hong Jae, Pinato, David J., and Pinter, Matthias

Published
2024
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6. 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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7. Predicting survival in patients with ‘non-high-risk’ acute variceal bleeding receiving β-blockers+ligation to prevent re-bleeding

Author

Balcar, Lorenz, Mandorfer, Mattias, Hernández-Gea, Virginia, Procopet, Bogdan, Meyer, Elias Laurin, Giráldez, Álvaro, Amitrano, Lucio, Villanueva, Candid, Thabut, Dominique, Samaniego, Luis Ibáñez, Silva-Junior, Gilberto, Martinez, Javier, Genescà, Joan, Bureau, Christophe, Trebicka, Jonel, Herrera, Elba Llop, Laleman, Wim, Palazón Azorín, José María, Alonso, Jose Castellote, Gluud, Lise Lotte, Ferreira, Carlos Noronha, Cañete, Nuria, Rodríguez, Manuel, Ferlitsch, Arnulf, Mundi, Jose Luis, Grønbæk, Henning, Hernandez Guerra, Manuel Nicolas, Sassatelli, Romano, Dell'Era, Alessandra, Senzolo, Marco, Abraldes, Juan Gonzalez, Romero-Gómez, Manuel, Zipprich, Alexander, Casas, Meritxell, Masnou, Helena, Primignani, Massimo, Krag, Aleksander, Nevens, Frederik, Calleja, Jose Luis, Jansen, Christian, Catalina, María Vega, Albillos, Agustín, Rudler, Marika, Tapias, Edilmar Alvarado, Guardascione, Maria Anna, Tantau, Marcel, Schwarzer, Rémy, Reiberger, Thomas, Laursen, Stig Borbjerg, Lopez-Gomez, Marta, Cachero, Alba, Ferrarese, Alberto, Ripoll, Cristina, La Mura, Vincenzo, Bosch, Jaime, and García-Pagán, Juan Carlos

Published
2024
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8. Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials

Author

Meyer, Elias Laurin, Mesenbrink, Peter, Dunger-Baldauf, Cornelia, Glimm, Ekkehard, Li, Yuhan, and König, Franz

Subjects
Statistics - Applications
Abstract

Platform trials have become increasingly popular for drug development programs, attracting interest from statisticians, clinicians and regulatory agencies. Many statistical questions related to designing platform trials - such as the impact of decision rules, sharing of information across cohorts, and allocation ratios on operating characteristics and error rates - remain unanswered. In many platform trials, the definition of error rates is not straightforward as classical error rate concepts are not applicable. For an open-entry, exploratory platform trial design comparing combination therapies to the respective monotherapies and standard-of-care, we define a set of error rates and operating characteristics and then use these to compare a set of design parameters under a range of simulation assumptions. When setting up the simulations, we aimed for realistic trial trajectories, such that e.g. a priori we do not know the exact number of treatments that will be included over time in a specific simulation run as this follows a stochastic mechanism. Our results indicate that the method of data sharing, exact specification of decision rules and a priori assumptions regarding the treatment efficacy all strongly contribute to the operating characteristics of the platform trial. Furthermore, different operating characteristics might be of importance to different stakeholders. Together with the potential flexibility and complexity of a platform trial, which also impact the achieved operating characteristics via e.g. the degree of efficiency of data sharing, this implies that utmost care needs to be given to evaluation of different assumptions and design parameters at the design stage.

Published
2021
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9. Regulatory Issues of Platform Trials: Learnings from EU‐PEARL.

Author

Nguyen, Quynh Lan, Hees, Katharina, Hernandez Penna, Sabina, König, Franz, Posch, Martin, Bofill Roig, Marta, Meyer, Elias Laurin, Freitag, Michaela Maria, Parke, Tom, Otte, Maximilian, Dauben, Hans‐Peter, Mielke, Tobias, Spiertz, Cecile, Mesenbrink, Peter, Gidh‐Jain, Madhavi, Pierre, Suzanne, Morello, Salvatore, and Hofner, Benjamin

Subjects
EXPERIMENTAL design, TECHNOLOGY assessment, MEDICAL technology, DRUG development, CLINICAL trials
Abstract

Although platform trials have many benefits, the complexity of these designs may result not only in increased methodological but also regulatory and ethical challenges. These aspects were addressed as part of the IMI project EU Patient‐Centric Clinical Trial Platforms (EU‐PEARL). We reviewed the available guidelines on platform trials in the European Union and the United States. This is supported and complemented by feedback received from regulatory interactions with the European Medicines Agency and the US Food and Drug Administration. Throughout the project we collected the needs of all relevant stakeholders including ethics committees, regulators, and health technology assessment bodies through active dialog and dedicated stakeholder workshops. Furthermore, we focused on methodological aspects and where applicable identified the corresponding guidance. Learnings from the guideline review, regulatory interactions, and workshops are provided. Based on these, a master protocol template was developed. Issues that still need harmonization or clarification in guidelines or where further methodological research is needed are also presented. These include questions around clinical trial submissions in Europe, the need for multiplicity control across the whole master protocol, the use of non‐concurrent controls, and the impact of different randomization schemes. Master protocols are an efficient and patient‐centered clinical trial design that can expedite drug development. However, they can also introduce additional operational and regulatory complexities. It is important to understand the different requirements of stakeholders upfront and address them in the trial. While relevant guidance is increasing, early dialog with relevant stakeholders can help to further support such designs. [ABSTRACT FROM AUTHOR]

Published
2024
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10. Simple blood tests to diagnose compensated advanced chronic liver disease and stratify the risk of clinically significant portal hypertension

Author

Semmler, Georg, primary, Hartl, Lukas, additional, Mendoza, Yuly Paulin, additional, Simbrunner, Benedikt, additional, Jachs, Mathias, additional, Balcar, Lorenz, additional, Schwarz, Michael, additional, Hofer, Benedikt Silvester, additional, Fritz, Laurenz, additional, Schedlbauer, Anna, additional, Stopfer, Katharina, additional, Neumayer, Daniela, additional, Maurer, Jurij, additional, Szymanski, Robin, additional, Meyer, Elias Laurin, additional, Scheiner, Bernhard, additional, Quehenberger, Peter, additional, Trauner, Michael, additional, Aigner, Elmar, additional, Berzigotti, Annalisa, additional, Reiberger, Thomas, additional, and Mandorfer, Mattias, additional

Published
2024
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11. 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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15. A meta-analysis and real-world cohort study on the sex-related differences in efficacy and safety of immunotherapy for hepatocellular carcinoma

Author

Balcar, Lorenz, primary, Scheiner, Bernhard, additional, Maria Fulgenzi, Claudia Angela, additional, D’Alessio, Antonio, additional, Pomej, Katharina, additional, Roig, Marta Bofill, additional, Meyer, Elias Laurin, additional, Cheon, Jaekyung, additional, Nishida, Naoshi, additional, Lee, Pei-Chang, additional, Wu, Linda, additional, Ang, Celina, additional, Krall, Anja, additional, Saeed, Anwaar, additional, Stefanini, Bernardo, additional, Cammarota, Antonella, additional, Pressiani, Tiziana, additional, Abugabal, Yehia I., additional, Chamseddine, Shadi, additional, Wietharn, Brooke, additional, Parisi, Alessandro, additional, Huang, Yi-Hsiang, additional, Phen, Samuel, additional, Vivaldi, Caterina, additional, Salani, Francesca, additional, Masi, Gianluca, additional, Bettinger, Dominik, additional, Vogel, Arndt, additional, von Felden, Johann, additional, Schulze, Kornelius, additional, Silletta, Marianna, additional, Trauner, Michael, additional, Samson, Adel, additional, Wege, Henning, additional, Piscaglia, Fabio, additional, Galle, Peter R., additional, Stauber, Rudolf, additional, Kudo, Masatoshi, additional, Singal, Amit G., additional, Itani, Aleena, additional, Ulahannan, Susanna V., additional, Parikh, Neehar D., additional, Cortellini, Alessio, additional, Kaseb, Ahmed, additional, Rimassa, Lorenza, additional, Chon, Hong Jae, additional, Pinato, David J., additional, and Pinter, Matthias, additional

Published
2023
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16. Predicting survival in patients with ‘non-high-risk’ acute variceal bleeding receiving β-blockers+ligation to prevent re-bleeding

Author

Balcar, Lorenz, primary, Mandorfer, Mattias, additional, Hernández-Gea, Virginia, additional, Procopet, Bogdan, additional, Meyer, Elias Laurin, additional, Giráldez, Álvaro, additional, Amitrano, Lucio, additional, Villanueva, Candid, additional, Thabut, Dominique, additional, Samaniego, Luis Ibáñez, additional, Silva-Junior, Gilberto, additional, Martinez, Javier, additional, Genescà, Joan, additional, Bureau, Christophe, additional, Trebicka, Jonel, additional, Llop Herrera, Elba, additional, Laleman, Wim, additional, Palazón Azorín, José María, additional, Castellote Alonso, Jose, additional, Gluud, Lise Lotte, additional, Noronha Ferreira, Carlos, additional, Cañete, Nuria, additional, Rodríguez, Manuel, additional, Ferlitsch, Arnulf, additional, Mundi, Jose Luis, additional, Grønbæk, Henning, additional, Hernandez Guerra, Manuel Nicolas, additional, Sassatelli, Romano, additional, Dell'Era, Alessandra, additional, Senzolo, Marco, additional, Abraldes, Juan Gonzalez, additional, Romero-Gómez, Manuel, additional, Zipprich, Alexander, additional, Casas, Meritxell, additional, Masnou, Helena, additional, Primignani, Massimo, additional, Krag, Aleksander, additional, Nevens, Frederik, additional, Calleja, Jose Luis, additional, Jansen, Christian, additional, Vega Catalina, María, additional, Albillos, Agustín, additional, Rudler, Marika, additional, Tapias, Edilmar Alvarado, additional, Guardascione, Maria Anna, additional, Tantau, Marcel, additional, Schwarzer, Rémy, additional, Reiberger, Thomas, additional, Laursen, Stig Borbjerg, additional, Lopez-Gomez, Marta, additional, Cachero, Alba, additional, Ferrarese, Alberto, additional, Ripoll, Cristina, additional, La Mura, Vincenzo, additional, Bosch, Jaime, additional, and García-Pagán, Juan Carlos, additional

Published
2023
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21. Disturbances in sodium and chloride homeostasis predict outcome in stable and critically ill patients with cirrhosis

Author

Semmler, Georg, primary, Scheiner, Bernhard, additional, Balcar, Lorenz, additional, Paternostro, Rafael, additional, Simbrunner, Benedikt, additional, Pinter, Matthias, additional, Trauner, Michael, additional, Bofill Roig, Marta, additional, Meyer, Elias Laurin, additional, Hofer, Benedikt Silvester, additional, Mandorfer, Mattias, additional, Pinato, David James, additional, Zauner, Christian, additional, Reiberger, Thomas, additional, and Funk, Georg‐Christian, additional

Published
2023
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24. Non-invasive tests for clinically significant portal hypertension after HCV-cure-individual patient data meta-analysis and validation

Author

Semmler, Georg, primary, Lens, Sabela, additional, Meyer, Elias Laurin, additional, Baiges, Anna, additional, Alvarado-Tapias, Edilmar, additional, Llop, Elba, additional, Martinez, Javier, additional, Schwabl, Philipp, additional, Mauro, Ezequiel, additional, Escude, Laia, additional, Diez, Cristina, additional, Ibañez, Luis, additional, Fortea, Jose Ignacio, additional, Puente, Angela, additional, Abadia, Marta, additional, Jia, Ji-Dong, additional, Yoshiji, Hitoshi, additional, Francque, Sven, additional, Tsochatzis, Emmanuel, additional, Bosch, Jaime, additional, Bañares, Rafael, additional, Crespo, Gonzalo, additional, Reiberger, Thomas, additional, Villanueva, Càndid, additional, Forns, Xavier, additional, Garcia Pagan, Juan Carlos, additional, and Mandorfer, Mattias, additional

Published
2022
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25. HCC risk stratification after cure of hepatitis C in patients with compensated advanced chronic liver disease

Author

Semmler, Georg, primary, Meyer, Elias Laurin, additional, Kozbial, Karin, additional, Schwabl, Philipp, additional, Hametner-Schreil, Stefanie, additional, Zanetto, Alberto, additional, Bauer, David, additional, Chromy, David, additional, Simbrunner, Benedikt, additional, Scheiner, Bernhard, additional, Stättermayer, Albert F., additional, Pinter, Matthias, additional, Schöfl, Rainer, additional, Russo, Francesco Paolo, additional, Greenfield, Helena, additional, Schwarz, Michael, additional, Schwarz, Caroline, additional, Gschwantler, Michael, additional, Alonso López, Sonia, additional, Manzano, Maria Luisa, additional, Ahumada, Adriana, additional, Bañares, Rafael, additional, Pons, Mònica, additional, Rodríguez-Tajes, Sergio, additional, Genescà, Joan, additional, Lens, Sabela, additional, Trauner, Michael, additional, Ferenci, Peter, additional, Reiberger, Thomas, additional, and Mandorfer, Mattias, additional

Published
2022
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26. Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints.

Author

Meyer, Elias Laurin, Mesenbrink, Peter, Di Prospero, Nicholas A., Pericàs, Juan M., Glimm, Ekkehard, Ratziu, Vlad, Sena, Elena, and König, Franz

Subjects
*NON-alcoholic fatty liver disease, *CONSORTIA, *DRUG development
Abstract

Non-alcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic fatty liver disease (NAFLD) and a disease with high unmet medical need. Platform trials provide great benefits for sponsors and trial participants in terms of accelerating drug development programs. In this article, we describe some of the activities of the EU-PEARL consortium (EU Patient-cEntric clinicAl tRial pLatforms) regarding the use of platform trials in NASH, in particular the proposed trial design, decision rules and simulation results. For a set of assumptions, we present the results of a simulation study recently discussed with two health authorities and the learnings from these meetings from a trial design perspective. Since the proposed design uses co-primary binary endpoints, we furthermore discuss the different options and practical considerations for simulating correlated binary endpoints. [ABSTRACT FROM AUTHOR]

Published
2023
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28. Evaluation of a Bariatric Monitoring Pass for Primary Care Physicians

Author

Ranzenberger-Haider, Tamara, primary, Meyer, Elias Laurin, additional, Stamm, Tanja, additional, Dreschl, Bettina, additional, Itariu, Bianca, additional, Prager, Gerhard, additional, Stangl, Anna, additional, Kautzky-Willer, Alexandra, additional, Schindler, Karin, additional, and Krebs, Michael, additional

Published
2022
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29. Adjunctive treatment with high-titre convalescent plasma in severely and critically ill COVID-19 patients – a safe but futile intervention. A comparative cohort study

Author

Hoepler, Wolfgang Paul, primary, Weidner, Lisa, additional, Traugott, Marianna Theresia, additional, Neuhold, Stephanie, additional, Meyer, Elias Laurin, additional, Zoufaly, Alexander, additional, Seitz, Tamara, additional, Kitzberger, Reinhard, additional, Baumgartner, Sebastian, additional, Pawelka, Erich, additional, Karolyi, Mario, additional, Grieb, Alexander, additional, Hind, Julian, additional, Laferl, Hermann, additional, Friese, Emanuela, additional, Wenisch, Christoph, additional, Aberle, Stephan Walter, additional, Aberle, Judith Helene, additional, Weseslindtner, Lukas, additional, and Jungbauer, Christoph, additional

Published
2021
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30. Decision rules for identifying combination therapies in open‐entry, randomized controlled platform trials.

Author

Meyer, Elias Laurin, Mesenbrink, Peter, Dunger‐Baldauf, Cornelia, Glimm, Ekkehard, Li, Yuhan, and König, Franz

Subjects
*ERROR rates, *GOVERNMENT agencies, *RATE setting, *DRUG development, *INFORMATION sharing
Abstract

Platform trials have become increasingly popular for drug development programs, attracting interest from statisticians, clinicians and regulatory agencies. Many statistical questions related to designing platform trials—such as the impact of decision rules, sharing of information across cohorts, and allocation ratios on operating characteristics and error rates—remain unanswered. In many platform trials, the definition of error rates is not straightforward as classical error rate concepts are not applicable. For an open‐entry, exploratory platform trial design comparing combination therapies to the respective monotherapies and standard‐of‐care, we define a set of error rates and operating characteristics and then use these to compare a set of design parameters under a range of simulation assumptions. When setting up the simulations, we aimed for realistic trial trajectories, such that for example, a priori we do not know the exact number of treatments that will be included over time in a specific simulation run as this follows a stochastic mechanism. Our results indicate that the method of data sharing, exact specification of decision rules and a priori assumptions regarding the treatment efficacy all strongly contribute to the operating characteristics of the platform trial. Furthermore, different operating characteristics might be of importance to different stakeholders. Together with the potential flexibility and complexity of a platform trial, which also impact the achieved operating characteristics via, for example, the degree of efficiency of data sharing this implies that utmost care needs to be given to evaluation of different assumptions and design parameters at the design stage. [ABSTRACT FROM AUTHOR]

Published
2022
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33. Systematic review of available software for multi-arm multi-stage and platform clinical trial design.

Author

Meyer, Elias Laurin, Mesenbrink, Peter, Mielke, Tobias, Parke, Tom, Evans, Daniel, König, Franz, and EU-PEARL (EU Patient-cEntric clinicAl tRial pLatforms) Consortium

Subjects
*EXPERIMENTAL design, *INTEGRATED software, *SOFTWARE architecture, *COMPUTER software
Abstract

Background: In recent years, the popularity of multi-arm multi-stage, seamless adaptive, and platform trials has increased. However, many design-related questions and questions regarding which operating characteristics should be evaluated to determine the potential performance of a specific trial design remain and are often further complicated by the complexity of such trial designs.Methods: A systematic search was conducted to review existing software for the design of platform trials, whereby multi-arm multi-stage trials were also included. The results of this search are reported both on the literature level and the software level, highlighting the software judged to be particularly useful.Results: In recent years, many highly specialized software packages targeting single design elements on platform studies have been released. Only a few of the developed software packages provide extensive design flexibility, at the cost of limited access due to being commercial or not being usable as out-of-the-box solutions.Conclusions: We believe that both an open-source modular software similar to OCTOPUS and a collaborative effort will be necessary to create software that takes advantage of and investigates the impact of all the flexibility that platform trials potentially provide. [ABSTRACT FROM AUTHOR]

Published
2021
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