Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL
Platform trials bring the promise of making clinical research more efficient and more patient centric. While their usehas become more widespread, including their prominent role during the COVID-19 pandemic response, broaderadoption of platform trials has been limited by the lack of experience and to...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2024 |
| País: | España |
| Institución: | Universitat Politècnica de Catalunya (UPC) |
| Repositorio: | UPCommons. Portal del coneixement obert de la UPC |
| Idioma: | inglés |
| OAI Identifier: | oai:upcommons.upc.edu:2117/424901 |
| Acceso en línea: | https://hdl.handle.net/2117/424901 https://dx.doi.org/10.1016/j.eclinm.2023.102384 |
| Access Level: | acceso abierto |
| Palabra clave: | Adaptive designs Master protocols Patient-centred Clinical research Integrated research platform Àrees temàtiques de la UPC::Economia i organització d'empreses |
| Sumario: | Platform trials bring the promise of making clinical research more efficient and more patient centric. While their usehas become more widespread, including their prominent role during the COVID-19 pandemic response, broaderadoption of platform trials has been limited by the lack of experience and tools to navigate the critical upfrontplanning 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 overarchinginfrastructure and services embedded into Integrated Research Platforms (IRPs), in collaboration with patient rep-resentatives and through consultation with U.S. Food and Drug Administration and European Medicines Agencystakeholders. In this narrative review, we discuss the outlook for platform trials in Europe, including challengesrelated to infrastructure, design, adaptations, data sharing and regulation. Documents derived from the EU-PEARLproject, alongside a literature search including PubMed and relevant grey literature (e.g., guidance from regulatoryagencies and health technology agencies) were used as sources for a multi-stage collaborative process through whichthe 10 more important points based on lessons drawn from the EU-PEARL project were developed and summarisedas guidance for the setup of platform trials. We conclude that early involvement of critical stakeholder such asregulatory 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 |
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