Comparing clinical trial population representativeness to real-world users of 17 biologics approved for immune-mediated inflammatory diseases: An external validity analysis of 66,639 biologic users from the Italian VALORE project

Comparing clinical trial population representativeness to real-world users of 17 biologics approved for immune-mediated inflammatory diseases: An external validity analysis of 66,639 biologic users from the Italian VALORE project

To date, no population-based studies have specifically explored the external validity of pivotal randomized clinical trials (RCTs) of biologics simultaneously for a broad spectrum of immuno-mediated inflammatory diseases (IMIDs). The aims of this study were, firstly, to compare the patients’ charact...

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Main Authors: Ylenia Ingrasciotta, Andrea Spini, Luca L'Abbate, Elena Sofia Fiore, Massimo Carollo, Valentina Ientile, Valentina Isgrò, Anna Cavazzana, Valeria Biasi, Paola Rossi, Lucian Ejlli, Valeria Belleudi, Francesca Poggi, Ester Sapigni, Aurora Puccini, Domenica Ancona, Paolo Stella, Sebastiano Pollina Addario, Alessandra Allotta, Olivia Leoni, Martina Zanforlini, Marco Tuccori, Rosa Gini, Gianluca Trifirò
格式: 文件
语言:English
出版: Elsevier 2024-02-01
丛编:Pharmacological Research
主题:
External validity
Immune-mediated inflammatory disease
Pivotal randomized clinical trial
Representativeness
Generalizability
Biological drugs
在线阅读:http://www.sciencedirect.com/science/article/pii/S1043661824000185

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