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

Author

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

Subjects
Adaptive designs, Master protocols, Patient-centred, Clinical research, Integrated research platform, Medicine (General), R5-920
Abstract

Summary: Platform trials bring the promise of making clinical research more efficient and more patient centric. While their use has become more widespread, including their prominent role during the COVID-19 pandemic response, broader adoption of platform trials has been limited by the lack of experience and tools to navigate the critical upfront planning required to launch such collaborative studies. The European Union-Patient-cEntric clinicAl tRial pLatform (EU-PEARL) initiative has produced new methodologies to expand the use of platform trials with an overarching infrastructure and services embedded into Integrated Research Platforms (IRPs), in collaboration with patient representatives and through consultation with U.S. Food and Drug Administration and European Medicines Agency stakeholders. In this narrative review, we discuss the outlook for platform trials in Europe, including challenges related to infrastructure, design, adaptations, data sharing and regulation. Documents derived from the EU-PEARL project, alongside a literature search including PubMed and relevant grey literature (e.g., guidance from regulatory agencies and health technology agencies) were used as sources for a multi-stage collaborative process through which the 10 more important points based on lessons drawn from the EU-PEARL project were developed and summarised as guidance for the setup of platform trials. We conclude that early involvement of critical stakeholder such as regulatory agencies or patients are critical steps in the implementation and later acceptance of platform trials. Addressing these gaps will be critical for attaining the full potential of platform trials for patients. Funding: Innovative Medicines Initiative 2 Joint Undertaking with support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.

Published
2024
Full Text
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2. A Delphi-method-based consensus guideline for definition of treatment-resistant depression for clinical trials

Author

Luca Sforzini, Courtney Worrell, Melisa Kose, Ian M. Anderson, Bruno Aouizerate, Volker Arolt, Michael Bauer, Bernhard T. Baune, Pierre Blier, Anthony J. Cleare, Philip J. Cowen, Timothy G. Dinan, Andrea Fagiolini, I. Nicol Ferrier, Ulrich Hegerl, Andrew D. Krystal, Marion Leboyer, R. Hamish McAllister-Williams, Roger S. McIntyre, Andreas Meyer-Lindenberg, Andrew H. Miller, Charles B. Nemeroff, Claus Normann, David Nutt, Stefano Pallanti, Luca Pani, Brenda W. J. H. Penninx, Alan F. Schatzberg, Richard C. Shelton, Lakshmi N. Yatham, Allan H. Young, Roland Zahn, Georgios Aislaitner, Florence Butlen-Ducuing, Christine Fletcher, Marion Haberkamp, Thomas Laughren, Fanni-Laura Mäntylä, Koen Schruers, Andrew Thomson, Gara Arteaga-Henríquez, Francesco Benedetti, Lucinda Cash-Gibson, Woo Ri Chae, Heidi De Smedt, Stefan M. Gold, Witte J. G. Hoogendijk, Valeria Jordán Mondragón, Eduard Maron, Jadwiga Martynowicz, Elisa Melloni, Christian Otte, Gabriela Perez-Fuentes, Sara Poletti, Mark E. Schmidt, Edwin van de Ketterij, Katherine Woo, Yanina Flossbach, J. Antoni Ramos-Quiroga, Adam J. Savitz, Carmine M. Pariante, Sforzini, L., Worrell, C., Kose, M., Anderson, I. M., Aouizerate, B., Arolt, V., Bauer, M., Baune, B. T., Blier, P., Cleare, A. J., Cowen, P. J., Dinan, T. G., Fagiolini, A., Ferrier, I. N., Hegerl, U., Krystal, A. D., Leboyer, M., McAllister-Williams, R. H., Mcintyre, R. S., Meyer-Lindenberg, A., Miller, A. H., Nemeroff, C. B., Normann, C., Nutt, D., Pallanti, S., Pani, L., Penninx, B. W. J. H., Schatzberg, A. F., Shelton, R. C., Yatham, L. N., Young, A. H., Zahn, R., Aislaitner, G., Butlen-Ducuing, F., Fletcher, C., Haberkamp, M., Laughren, T., Mantyla, F. -L., Schruers, K., Thomson, A., Arteaga-Henriquez, G., Benedetti, F., Cash-Gibson, L., Chae, W. R., De Smedt, H., Gold, S. M., Hoogendijk, W. J. G., Mondragon, V. J., Maron, E., Martynowicz, J., Melloni, E., Otte, C., Perez-Fuentes, G., Poletti, S., Schmidt, M. E., van de Ketterij, E., Woo, K., Flossbach, Y., Ramos-Quiroga, J. A., Savitz, A. J., Pariante, C. M., Institute of Psychiatry, Psychology & Neuroscience, King's College London, King‘s College London, Nutrition et Neurobiologie intégrée (NutriNeuro), Université de Bordeaux (UB)-Institut Polytechnique de Bordeaux-Ecole nationale supérieure de chimie, biologie et physique-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Department of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden = Dresden University of Technology (TU Dresden), The Florey Institute of Neuroscience and Mental Health, University of Melbourne, IMRB - 'Neuropsychiatrie translationnelle' [Créteil] (U955 Inserm - UPEC), Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), and European Project: (grant No 116060),IMPRiND

Subjects
Depression, Diagnostic markers, DISORDER, STIMULATION, STAR-ASTERISK-D, SEROTONIN REUPTAKE INHIBITORS, Major Depressive Disorder, Clinical Trials and Supportive Activities, Medical and Health Sciences, Depressive Disorder, Treatment-Resistant, Cellular and Molecular Neuroscience, REPORT QIDS-SR, SDG 3 - Good Health and Well-being, Clinical Research, Humans, RATING-SCALE, Molecular Biology, METAANALYSIS, Psychiatry, Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant, Psychology and Cognitive Sciences, Major, REMISSION, Biological Sciences, Serious Mental Illness, Brain Disorders, Psychiatry and Mental health, QUICK INVENTORY, Mental Health, Good Health and Well Being, SYMPTOMATOLOGY, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]
Abstract

Criteria for treatment-resistant depression (TRD) and partially responsive depression (PRD) as subtypes of major depressive disorder (MDD) are not unequivocally defined. In the present document we used a Delphi-method-based consensus approach to define TRD and PRD and to serve as operational criteria for future clinical studies, especially if conducted for regulatory purposes. We reviewed the literature and brought together a group of international experts (including clinicians, academics, researchers, employees of pharmaceutical companies, regulatory bodies representatives, and one person with lived experience) to evaluate the state-of-the-art and main controversies regarding the current classification. We then provided recommendations on how to design clinical trials, and on how to guide research in unmet needs and knowledge gaps. This report will feed into one of the main objectives of the EUropean Patient-cEntric clinicAl tRial pLatforms, Innovative Medicines Initiative (EU-PEARL, IMI) MDD project, to design a protocol for platform trials of new medications for TRD/PRD.

Published
2022
Full Text
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3. Substance-abusing physicians: monitoring and twelve-step-based treatment

Author

Marc Galanter, Helen Dermatis, John S. McIntyre, Gabriela Perez-Fuentes, and Peter A. Mansky

Subjects
Adult, Male, Mental Health Services, medicine.medical_specialty, Substance-Related Disorders, media_common.quotation_subject, medicine.medical_treatment, MEDLINE, Medicine (miscellaneous), Monitoring, Ambulatory, Logistic regression, Recurrence, Physicians, Surveys and Questionnaires, medicine, Humans, Workplace, media_common, Rehabilitation, business.industry, Convalescence, Incidence (epidemiology), Attendance, Abstinence, medicine.disease, Substance abuse, Psychiatry and Mental health, Clinical Psychology, Family medicine, Patient Compliance, Female, Medical emergency, business
Abstract

This study was designed to provide an independent evaluation of the oversight and rehabilitation of substance-impaired physicians. Records of 104 physicians who had completed their monitoring period by the New York State Committee on Physicians' Health were selected at random from CPH files. They had been followed for an average of 41.3 months. Practice characteristics and substance use before admission, as well as workplace monitoring, twelve-step attendance, urine toxicologies, and relapse incidence after admission are reported. Significant intercorrelations among these variables were ascertained by logistic regression. The utility of twelve-step-based rehabilitation as part of a treatment plan for sustaining abstinence and averting relapse is discussed.

Published
2007

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