b8ec7c7dd682f8c8bf722268f84b828d Current_state-of-the-art.pdf e9a9f6dbc2615808881a71d0a1d47619b45769c7 Current_state-of-the-art.pdf 18566adcf2e60199c6a9018d8b551c2c6331525a6cd36dafb7b8d179fd248ed2 Current_state-of-the-art.pdf Title: Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL Subject: eClinicalMedicine, 67 (2024) 102384. doi:10.1016/j.eclinm.2023.102384 Author: Franz Koenig Creator: Elsevier Producer: Acrobat Distiller 8.1.0 (Windows) CreationDate: Tue Dec 26 19:09:44 2023 CET ModDate: Tue Dec 26 19:10:20 2023 CET Custom Metadata: yes Metadata Stream: yes Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 12 Encrypted: no Page size: 595.276 x 793.701 pts Page rot: 0 File size: 402349 bytes Optimized: yes PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- BCKHEJ+AdvTTac2dc932 Type 1C WinAnsi yes yes no 743 0 BCKHCO+AdvOT20212610.B Type 1C WinAnsi yes yes no 710 0 BCKHCP+AdvOT2867105d.I Type 1C WinAnsi yes yes no 712 0 BCKHDA+AdvstixtSym Type 1C Custom yes yes yes 717 0 BCKHDB+AdvOT3f9da5b7 Type 1C WinAnsi yes yes no 719 0 BCKHDC+AdvOT3f9da5b7+20 Type 1C WinAnsi yes yes no 721 0 BCKHED+AdvTT0d8bc80f.B Type 1C WinAnsi yes yes no 730 0 BCKHEE+AdvTT0d8bc80f.B+fb Type 1C Custom yes yes yes 724 0 BCKHEF+AdvTT0d8bc80f.B+20 Type 1C WinAnsi yes yes no 726 0 BCKHEG+AdvTTae869a4c Type 1C WinAnsi yes yes no 728 0 BCKHEH+AdvTTae869a4c+fb Type 1C Custom yes yes yes 740 0 BCKHEI+AdvTTae869a4c+20 Type 1C WinAnsi yes yes no 735 0 BCKHJJ+AdvTTb4077e6a Type 1C WinAnsi yes yes no 414 0 BCKHKK+AdvOT3f9da5b7+fb Type 1C Custom yes yes yes 405 0 BCKHJI+ArialMT CID TrueType Identity-H yes yes yes 406 0 BCKHML+Ebrima-Bold TrueType WinAnsi yes yes no 420 0 BCKHOL+AdvOT20212610.B+fb Type 1C Custom yes yes yes 432 0 BCKIDK+AdvTTac2dc932+20 Type 1C WinAnsi yes yes no 451 0 BCKIDL+AdvTTac2dc932+fb Type 1C Custom yes yes yes 452 0 Jhove (Rel. 1.28.0, 2023-05-18) Date: 2026-05-20 04:08:55 CEST RepresentationInformation: Current_state-of-the-art.pdf ReportingModule: PDF-hul, Rel. 1.12.4 (2023-03-16) LastModified: 2026-05-19 15:36:28 CEST Size: 402349 Format: PDF Version: 1.7 Status: Well-Formed, but not valid SignatureMatches: PDF-hul ErrorMessage: Invalid indirect destination - referenced object 'appsec1' cannot be found ID: PDF-HUL-149 ErrorMessage: edu.harvard.hul.ois.jhove.module.pdf.PdfInvalidException: Invalid indirect destination - referenced object 'appsec1' cannot be found ID: PDF-HUL-122 Offset: 360720 MIMEtype: application/pdf Profile: Linearized PDF PDFMetadata: Objects: 813 FreeObjects: 1 IncrementalUpdates: 1 DocumentCatalog: PageLayout: SinglePage PageMode: UseOutlines Language: en Outlines: Item: Title: Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL Destination: titlink1 Children: Item: Title: Introduction Destination: flink1 Item: Title: Writing approach of this narrative review Destination: flink2 Item: Title: Integrated research platforms are centred on a platform trial master protocol Destination: flink3 Item: Title: Early consultation with regulators can yield an optimised regulatory pathway Destination: flink4 Item: Title: Platform trials enable patient-centric approaches from their inception Destination: flink5 Item: Title: Clinical research networks provide the infrastructure on which the IRP can be established Destination: flink6 Item: Title: Improving efficiency through adaptive clinical trial design Destination: flink7 Item: Title: Master protocols provide the framework for reusable clinical research infrastructures Destination: flink8 Item: Title: Electronic health records can be leveraged to assess trial feasibility and site selection Destination: flink9 Item: Title: Legal frameworks enable effective collaboration across the diverse parties participating in IRPs Destination: flink10 Item: Title: To be sustainable, platform trials require a business plan which creates value for all trial stakeholders Destination: flink11 Item: Title: Platform trials and IRPs must address key gaps in drug development Destination: flink12 Item: Title: Future directions and remaining challenges Destination: flink13 Children: Item: Title: Readiness of non-traditional sponsors Destination: slink1 Item: Title: Data sharing challenges Destination: slink2 Item: Title: Regulatory requirements lag the regulatory vision Destination: slink3 Item: Title: Conclusions Destination: flink14 Item: Title: ContributorsConceptualisation and design: FK, CS, SRN, DM, NM, JMP, MP; Drafting of the article: FK, CS, SRN, DM, JMP, MP; ... Destination: blink1 Item: Title: Declaration of interests Destination: blink2 Item: Title: Acknowledgements Destination: blink3 Item: Title: Appendix A. 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Pericàs Martin Posch EU-PEARL Consortium 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 Joan Genescà 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 Sarai Rodríguez-Navarro 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 Franz Koenig Marta Bofill Roig Martin Brunner Martin Posch 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 Amelie Michon 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 Ann Van Dessel Anna Duca Anne Kaminski Bie Wouters Brandon Porter Catherine Charron Cecile Spiertz Christopher Zizzamia Daniel Millar 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 Chris Lynch Adaptive designs Master protocols Patient-centred Clinical research Integrated research platform eClinicalMedicine, 67 (2024) 102384. doi:10.1016/j.eclinm.2023.102384 The Authors journal eClinicalMedicine © 2023 The Authors. 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