Publications by authors named "Peter Mol"

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Real-World Data Included in Post-authorisation Measures: A Case Study of Approved Advanced Therapy Medicinal Products in the European Union between 2013 and 2024.
Diogo Almeida, Diana Mandslay, Peter G M Mol, Bruno Sepodes, Carla Torre

BioDrugs· November 2025

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Views of European Union medicine regulators and healthcare professionals on the approved versus prescribed dose of protein kinase inhibitors: an interview study.
Margot Brinkhof, Sieta T de Vries, Peter G M Mol, Dario Trapani, Irja Marije de Jong

BMJ Open· November 2025

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Timing of Cardiac Resynchronization Therapy Following Stable Medical Therapy in Patients With Heart Failure.
Alessandro Villaschi, Christian Basile, Lina Benson, Paolo Gatti, William T Abraham, Peter Mol

JACC Heart Fail· October 2025

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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.
Sonia Zebachi, Julien Tanniou, Elisabeth Bakker, Sieta T de Vries, Rossella Di Bidino, Peter G M Mol

Clin Pharmacol Ther· October 2025

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The European Medicines Agency's review of Kaftrio (elexacaftor-tezacaftor-ivacaftor): extending its use to all people with CF aged 2 years and older who do not have two class I variants.
Catherine Drai, Hanneke J van der Woude, Anne J Lexmond, Tineke van den Hoorn, Peter G M Mol

Eur Respir J· October 2025

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Optimizing Patient Registries for Regulatory Decision Making - Key Learnings From an HMA/EMA Multistakeholder Workshop.
Kelly Plueschke, Carla Jonker, Hanna Kankanen, Thorsten Vetter, Bruno Sepodes, Peter Mol

Clin Pharmacol Ther· September 2025

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Beta-blockers in patients with heart failure with reduced ejection fraction and concomitant chronic obstructive pulmonary disease: Cardiovascular and respiratory outcomes.
Benedikt N Beer, Lina Benson, Christian Basile, Benedikt Schrage, Peter Moritz Becher, Peter G M Mol

Eur J Heart Fail· September 2025

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Stakeholders' Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey.
Fabian Windfuhr, Sieta T de Vries, Maria Melinder, Tanja Dahlqvist, Diogo Almeida, Peter G M Mol

Drug Saf· July 2025

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Arrival of biosimilars in respiratory medicine: towards improved access to biologics for patients.
Job F M van Boven, Fernando de Mora, Giorgio W Canonica, Peter G M Mol, Arnold G Vulto

Lancet Respir Med· July 2025

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Using patient-reported outcomes and health-related quality of life data in regulatory decisions on cancer treatment: highlights from an EMA-EORTC workshop.
Madeline Pe, Caroline Voltz-Girolt, Jill Bell, Vishal Bhatnagar, Jan Bogaerts, Pierre Demolis, Peter Mol

Lancet Oncol· June 2025

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Use of patient-reported outcomes to inform symptom and functional outcomes in cancer drug regulatory decisions: challenges and future directions.
Francesco Pignatti, Peter Mol, Chantal Quinten, Douwe Postmus, Anja Schiel

Lancet Oncol· June 2025

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Insights from the European Medicines Agency on digital health technology derived endpoints.
Keerti D Jadoenathmisier, Helga Gardarsdottir, Peter G M Mol, Anna M G Pasmooij

Drug Discov Today· June 2025

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Long-term follow-up after authorization of gene therapy: leveraging real-world data.
Karin de Haart, Keiko Asao, Quazi Ataher, Jamie Geier, Jodie Hillen, Peter G M Mol

Drug Discov Today· May 2025

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Future treatment paradigms in pulmonary arterial hypertension: a personal view from physicians, health authorities, and patients.
Franck F Rahaghi, Marc Humbert, Marius M Hoeper, R James White, Robert P Frantz, Peter G M Mol

Lancet Respir Med· April 2025

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Reassessing pembrolizumab dosing in NSCLC for methodological and clinical accuracy - Author's reply.
Geeske F Grit, Peter G M Mol, Doranne Hilarius

Lung Cancer· April 2025

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Withdrawal of Guideline-Directed Medical Therapy in Patients With Heart Failure and Improved Ejection Fraction.
Christian Basile, Felix Lindberg, Lina Benson, Federica Guidetti, Ulf Dahlström, Peter Mol

Circulation· April 2025

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Dispensing Patterns of Inhaled Asthma Medication Before and During COVID-19 Among Young Adults in the Netherlands: A Retrospective Inception Cohort Study.
Guiling Zhou, Irene Mommers, Catharina C M Schuilinga-Veninga, Jens H J Bos, Katrien Oude Rengerink, Peter G M Mol

Clin Epidemiol· April 2025

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Sex differences in the efficacy of angiotensin receptor blockers on kidney and cardiovascular outcomes among individuals with type 2 diabetes and diabetic kidney disease: post hoc analyses of the RENAAL and IDNT trials.
Sieta T de Vries, Michelle J Pena, Sok Cin Tye, Sanne A E Peters, Daniël H van Raalte, Peter G M Mol

Diabetologia· March 2025

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Mixed Impact of Direct Healthcare Professional Communications When Considering Proximal Outcomes and the Targeted Population: A Systematic Review.
Esther de Vries, Petra Denig, Taco B M Monster, Peter G M Mol

Pharmacoepidemiol Drug Saf· March 2025

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Biomarkers for neurodegenerative diseases in regulatory decision-making by the European Medicines Agency.
Audrey M M Hermans, Elisabeth Bakker, Viktoriia Starokozhko, Loes den Otter, André J A Elferink, Peter G M Mol

Alzheimers Dement (N Y)· March 2025

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Perspectives of People with Type 2 Diabetes Mellitus Towards a Decision Aid Assessing Preferences of Glucose-Lowering Drugs: The Dilemma of Choosing.
Sonia Roldan Munoz, Peter G M Mol, Femke de Vries, Peter R van Dijk, Hans Hillege

Patient Prefer Adherence· January 2025

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Effectiveness of COVID-19 vaccines against SARS-CoV-2 infection and severe outcomes in adults: a systematic review and meta-analysis of European studies published up to 22 January 2024.
Guiling Zhou, Nina Dael, Stefan Verweij, Spyros Balafas, Sumaira Mubarik, Peter G M Mol

Eur Respir Rev· January 2025

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Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases.
Stefanie Prilla, Sophie Groeneveld, Alexandra Pacurariu, María Clara Restrepo-Méndez, Patrice Verpillat, Peter G M Mol

Clin Pharmacol Ther· November 2024

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Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.
Francine Brinkhuis, Elaine Julian, Hendrika van den Ham, Fabrizio Gianfrate, Valentina Strammiello, Peter Mol

Health Res Policy Syst· July 2024

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Monoclonal antibody biosimilars for cancer treatment.
Linda N Broer, Daan G Knapen, Derk-Jan A de Groot, Peter G M Mol, Jos G W Kosterink

iScience· June 2024

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