Patient-reported outcomes and treatment adherence in type 2 diabetes using natural language processing: Wave 8 of the Observational International Diabetes Management Practices Study

Publisher: Journal of Diabetes Investigation Authors: Juliana CN Chan, Jean Claude Mbanya, Jean-Marc Chantelot, Marina Shestakova, Ambady Ramachandran, Hasan Ilkova, Lucille Deplante, Melissa Rollot, Lydie Melas-Melt, Juan Jose Gagliardino, Pablo Aschner View Publication Aims/Introduction We analyzed patient-reported outcomes of people with type 2 diabetes to better understand perceptions and experiences contributing to treatment adherence. Materials and […]

Navigating the Real World: A Scoping Review of Structured Frameworks to Effectively Identify, Evaluate, and Select Real-World Data Sources for Fit-for-Purpose Studies

Publisher: Clinical Pharmacology and Therapeutics Authors: Sonia Zebachi, Julien Tanniou, Elisabeth Bakker, Sieta T. de Vries, Rossella Di Bidino, Entela Xoxi, Anna Glaser, Gianluigi Savarese, Jan Hillert, Peter G.M. Mol, Kelly Plueschke, Billy Amzal, Ghinwa Y. Hayek, Jeverson Moreira View publication Abstract The potential of real-world data (RWD), particularly from patient registries, has been increasingly recognized […]

Policy makers must adopt agile signal detection tools to strengthen epidemiological surveillance and improve pandemic preparedness

Publisher: Health Policy Authors: Cédric Mahé, Aimo Kannt, AIOLOS Consortium View publication Abstract The SARS-COV2 pandemic has highlighted the urgent need for agile and responsive disease surveillance systems. To strengthen epidemiological surveillance and improve pandemic preparedness, policymakers must adopt real-time signal detection tools that integrate multisource data, including non-traditional health data, advanced analytics, and artificial […]

A text-to-tabular approach to generate synthetic patient data using LLMs

Publisher: IEEE XploreAuthors: Margaux Tornqvist, Jean-Daniel Zucker, Tristan Fauvel, Nicolas Lambert, Mathilde Berthelot, Antoine Movschin View publication Abstract Access to large-scale high-quality healthcare databases is key to accelerate medical research and make insightful discoveries about diseases. However, access to such data is often limited by patient privacy concerns, data sharing restrictions and high costs. To […]

Federated Learning: A Privacy-Preserving Approach to Data-Centric Regulatory Cooperation

Publisher: Frontiers in Drug Safety and RegulationAuthors: Alexander Horst, Paul Loustalot, Sanjeev Yoganathan, Ting Li, Joshua Xu, Weida Tong, David Schneider, Nicolas Löffler-Perez, Erminio Di Renzo, Michael Renaudin View Publication Abstract Regulatory agencies aim to ensure the safety and efficacy of medical products but often face legal and privacy concerns that hinder collaboration at the […]

Analyzing recurrent events in multiple sclerosis: a review of statistical models with application to the MSOAC database

Publisher: Journal of NeurologyAuthors: David Herman, Julien Tanniou, Emmanuelle Leray, Chloe Pierret, Quentin Pilard View Publication Abstract Patients with multiple sclerosis (MS) are susceptible to experience recurrent events of disability progression and relapses. Many studies still focus on analyzing MS events with traditional methods such as Cox proportional hazards, Poisson, and logistic regression that either […]

Comparison of Bayesian methods for extrapolation of treatment effects: a large scale simulation study

Publisher: arXivAuthors: Tristan Fauvel, Julien Tanniou, Pascal Godbillot, Billy Amzal View Publication Abstract Extrapolating treatment effects from related studies is a promising strategy for designing and analyzing clinical trials in situations where achieving an adequate sample size is challenging. Bayesian methods are well-suited for this purpose, as they enable the synthesis of prior information through the use of […]

Decision-Making Criteria and Methods for Initiating Late-Stage Clinical Trials in Drug Development from a Multi-Stakeholder Perspective: A Scoping Review

Publisher: Clinical Pharmacology and Therapeutics Authors: Ce Jiang, Céline Beji, Sonia Zebachi, Ghinwa Y. Hayek, Aysun Cetinyurek-Yavuz, Muhammad Bergas N. Fayyad, Laura Rodwell, Kit C. B. Roes, Billy Amzal, Christoph Gerlinger, Raphaël Porcher, Julien Tanniou View Publication The decision-making process in drug development involves “go/no-go” decisions, particularly at the transition from early to late-stages trials. […]

Connecting Electronic Health Records to a Biomedical Knowledge Graph to Link Clinical Phenotypes and Molecular Endotypes in Atopic Dermatitis

Publisher: Nature Scientific Reports Authors: Francesca Frau, Paul Loustalot, Margaux Törnqvist, Nina Temam, Jean Cupe, Martin Montmerle, Franck Augé View Publication Abstract Precision medicine is defined by the U.S. Food & Drug Administration as “an innovative approach to tailoring disease prevention and treatment that considers differences in people’s genes, environments, and lifestyles”. To succeed in […]

On the Concepts, Methods, and Use of “Probability of Success” for Drug Development Decision-Making: A Scoping Review

Publisher: Clinical Pharmacology and Therapeutics Authors: Aysun Cetinyurek Yavuz, Muhammad Bergas Nur Fayyad, Ce Jiang, Florie Brion Bouvier, Celine Beji, Sonia Zebachi, Ghinwa Y. Hayek, Billy Amzal, Raphael Porcher, Julien Tanniou, Kit Roes, Laura Rodwell View publication Abstract Drug development is a lengthy process with considerable uncertainty at each milestone. Several trials are needed to progress […]