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Liver Unit, Hospital Clínic, Institut de Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Which clinical trial designs and statistical approaches have been used in assessments of orphan maintenance by the European Medicines Agency between 2012 and 2022? A cross-sectional study.
BMJ Open
December 2024
European Medicines Agency, Amsterdam, The Netherlands
Objectives: In the European Union, a new orphan medicinal product must demonstrate 'significant benefit' over approved medicinal products targeting the same indication. To demonstrate a significant benefit, comparisons between the new product and the already approved medicinal products-either directly by a head-to-head comparison within a clinical trial or indirectly as a cross-trial comparison-are necessary. In this study, we investigate the types of trial designs and statistical approaches used for demonstrating a significant benefit of a new orphan medicinal product against approved comparators used between 2012 and 2022.
View Article and Find Full Text PDFEditorial Perspective: What do we need to know about the manosphere and young people's mental health?
Child Adolesc Ment Health
January 2025
Department of Psychology, University of York, York, UK.
The manosphere is an international network of social media influencers and communities promoting male supremacy and antifeminist ideologies. Young men are engaging with this extremist content at high rates. Despite growing concerns among educators, policymakers and researchers, systematic data on the long-term impact of the manosphere on young people's mental health and behaviour remains limited.
View Article and Find Full Text PDFPrevalence of processed foods in major US grocery stores.
Nat Food
January 2025
Network Science Institute and Department of Physics, Northeastern University, Boston, MA, USA.
The offering of grocery stores is a strong driver of consumer decisions. While highly processed foods such as packaged products, processed meat and sweetened soft drinks have been increasingly associated with unhealthy diets, information on the degree of processing characterizing an item in a store is not straightforward to obtain, limiting the ability of individuals to make informed choices. GroceryDB, a database with over 50,000 food items sold by Walmart, Target and Whole Foods, shows the degree of processing of food items and potential alternatives in the surrounding food environment.
View Article and Find Full Text PDFThe birth of the virtual clinic: welcome to the Mediverse.
Adv Health Sci Educ Theory Pract
January 2025
The Wilson Centre, University of Toronto & University Health Network, Toronto, ON, Canada.
The COVID-19 pandemic triggered a global pivot to virtual care (VC) technologies. While there has been considerable academic work exploring the "how" of VC, few studies have explored the impact of this pivot, its unintended consequences, and its governing rationales. This study addresses this gap in relation to care, professional identity and the evolving requirements for health professions education.
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