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

Autor: 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, Chris Lynch

Publikováno v: EClinicalMedicine, Vol 67, Iss , Pp 102384- (2024)

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 plat

Externí odkaz: https://doaj.org/article/f59c23359d8f43f08f6d61eafda30803

Analysis of Dynamic Efficacy Endpoints of the Nix-TB Trial

Autor: Belén P Solans, Marjorie Z Imperial, Morounfolu Olugbosi, Rada M Savic

Publikováno v: Clinical Infectious Diseases.

BackgroundSafer, better, and shorter treatments for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) are an urgent global health need. The phase 3 clinical trial Nix-TB (NCT02333799) tested a 6-month treatment of MDR a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::51e1cd54e19bbc50f2d6b165aff961b8
https://doi.org/10.1093/cid/ciad051

Treatment of Highly Drug-Resistant Pulmonary Tuberculosis

Autor: Francesca, Conradie, Andreas H, Diacon, Nosipho, Ngubane, Pauline, Howell, Daniel, Everitt, Angela M, Crook, Carl M, Mendel, Erica, Egizi, Joanna, Moreira, Juliano, Timm, Timothy D, McHugh, Genevieve H, Wills, Anna, Bateson, Robert, Hunt, Christo, Van Niekerk, Mengchun, Li, Morounfolu, Olugbosi, Melvin, Spigelman, Priya, Solanki

Publikováno v: The New England Journal of Medicine

Patients with highly drug-resistant forms of tuberculosis have limited treatment options and historically have had poor outcomes.In an open-label, single-group study in which follow-up is ongoing at three South African sites, we investigated treatmen

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ee21f75b6670406c82d4718f930b5800
https://doi.org/10.1056/nejmoa1901814

Antibody Kinetics and Response to Routine Vaccinations in Infants Born to Women Who Received an Investigational Trivalent Group B Streptococcus Polysaccharide CRM197-Conjugate Vaccine During Pregnancy

Autor: Morounfolu Olugbosi, Niresha Govender, Karen S. Slobod, Anthonet Koen, Clare L. Cutland, Sherryl Baker, Vas Narasimhan, Frederick Wittke, Shabir A. Madhi, Ajoke Sobanjo-ter Meulen, Lisa Jose, Peter M. Dull

Publikováno v: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America

Group B Streptococcus (GBS)–specific antibodies were detectable in 3-month-old infants of mothers having received an investigational trivalent GBS vaccine during pregnancy. Maternal GBS vaccination did not have a clinically meaningful impact on imm

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cdbe2560ca0373846d5fb085091d9963
http://europepmc.org/articles/PMC5848233

Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country

Autor: Marianne Cunnington, Clare L. Cutland, Stephanie Jones, Karen Slobod, Morounfolu Olugbosi, Shabir A. Madhi, Andrea Hugo, Karishma Maharaj

Publikováno v: Vaccine. 33:6406-6412

Introduction Infectious causes are a significant contributor to morbidity and mortality in neonates and young infants. Immunization of pregnant women to protect the mother and/or her infant is gaining momentum due to the benefits of this strategy dem

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::35d5e39ea33854df3c8b69ad388bfd5d
https://doi.org/10.1016/j.vaccine.2015.08.040