Zobrazeno 1 - 10
of 27
pro vyhledávání: '"Tom Parke"'
Autor:
Madhavi Gidh-Jain, Tom Parke, Franz König, Cecile Spiertz, Peter Mesenbrink, On behalf of EU-PEARL (Europe [EU] Patient-cEntric clinicAl tRial pLatforms) an Innovative Medicines Initiative (IMI) initiative Work Package 2 (WP 2)
Publikováno v:
Trials, Vol 25, Iss 1, Pp 1-12 (2024)
Abstract Background Interventional clinical studies conducted in the regulated drug research environment are designed using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E6 (R2) Good Clinical Practice—scientific g
Externí odkaz:
https://doaj.org/article/41034feb6c904b84bbff4537bf0f0790
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
Publikováno v:
SoftwareX, Vol 23, Iss , Pp 101515- (2023)
Platform trials are becoming increasingly popular within drug development, attracting interest by patients, clinicians, regulatory agencies and statisticians. More often than not, these platform trial designs are highly complex and involve many weakl
Externí odkaz:
https://doaj.org/article/8cd6d7500e884b0badb32f56dfc28eaf
Systematic review of available software for multi-arm multi-stage and platform clinical trial design
Autor:
Elias Laurin Meyer, Peter Mesenbrink, Tobias Mielke, Tom Parke, Daniel Evans, Franz König, on behalf of EU-PEARL (EU Patient-cEntric clinicAl tRial pLatforms) Consortium
Publikováno v:
Trials, Vol 22, Iss 1, Pp 1-14 (2021)
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
Externí odkaz:
https://doaj.org/article/4fc027e748404fc68a469501910bf7cb
Publikováno v:
Pharmaceutical Statistics
Subgroup by treatment interaction assessments are routinely performed when analysing clinical trials and are particularly important for phase 3 trials where the results may affect regulatory labelling. Interpretation of such interactions is particula
Improving Oncology Clinical Programs by Use of Innovative Designs and Comparing Them via Simulations
Publikováno v:
Therapeutic innovationregulatory science. 47(5)
The design of an oncology clinical program is much more challenging than the design of a single study. The standard approach has been proven to be not very successful during the past decade; the failure rate of phase 3 studies in oncology is about 66
Publikováno v:
Therapeutic innovationregulatory science. 48(1)
The International Society for CNS Clinical Trials and Methodology (ISCTM) Adaptive Design Working Group (IADWG) designed a case study simulation exercise to compare the value of traditional versus adaptive design approaches to phase II clinical trial
Autor:
Nancy Burnham, Micheline Marshall, Graham Nicholls, L. B. Wong, Nitin Patel, Tom Parke, Weili He, Judith Quinlan
Publikováno v:
Therapeutic Innovation & Regulatory Science. 49:100-107
During the past decade, there has been increasing interest in adaptive clinical trials in pharmaceutical drug development as a means to improved decision making, better dose selection, and reduction in cost and time to market. Nevertheless, the opera
Autor:
Olga Marchenko, Vladimir V. Anisimov, Guochen Song, Inna Perevozskaya, Christopher Jennison, Anastasia Ivanova, Tom Parke
Publikováno v:
Parke, T, Marchenko, O, Anisimov, V, Ivanova, A, Jennison, C, Perevozskaya, I & Song, G 2017, ' Comparing oncology clinical programs by use of innovative designs and expected net present value optimization : which adaptive approach leads to the best result? ', Journal of Biopharmaceutical Statistics, vol. 27, no. 3, pp. 457-476 . https://doi.org/10.1080/10543406.2017.1289949
Designing an oncology clinical program is more challenging than designing a single study. The standard approaches have been proven to be not very successful during the last decade; the failure rate of Phase 2 and Phase 3 trials in oncology remains hi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bad3ad5c4ed56a248dee672214a69478
https://purehost.bath.ac.uk/ws/files/157222220/Parke_et_al_for_JBPS.pdf
https://purehost.bath.ac.uk/ws/files/157222220/Parke_et_al_for_JBPS.pdf
Autor:
Tom Parke
Publikováno v:
Clinical Investigation. 5:355-357
Using an adaptive design [1] for a drug’s Phase II trial allows a drug developer to get better value from their asset and have a cost profile more attractive to their investors [2]. Large pharmaceuticals are slowly coming round to realizing this [3