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Nature Reviews. Clinical Oncology|December 7, 2021
The value of anticancer drugs - a regulatory viewFrancesco Pignatti, Ulla Wilking, Douwe Postmus, et al.
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|August 17, 2011
The European Medicines Agency: an overview of its mission, responsibilities, and recent initiatives in cancer drug regulationFrancesco Pignatti, Iordanis Gravanis, Ralf Herold, et al.
Clinical Pharmacology and Therapeutics|May 13, 2025
Expedited Approval in Oncology: A Study of European Regulators' Perspectives and Trade-OffsFrancesco Pignatti, Filip Josephson, Pierre Demolis, et al.
Drug Safety|July 27, 2022
A Review of Causal Inference for External Comparator Arm StudiesGerd Rippin, Nicolás Ballarini, Héctor Sanz, et al.
The Oncologist|December 16, 2010
The European Medicines Agency review of ofatumumab (Arzerra®) for the treatment of chronic lymphocytic leukemia in patients refractory to fludarabine and alemtuzumab: summary of the scientific assessment of the European medicines agency committee for medicinal products for human useIordanis Gravanis, Jens Ersbøll, Eva Skovlund, et al.
European Journal of Cancer (Oxford, England : 1990)|December 22, 2023
Attitudes of healthcare professionals and drug regulators about progression-free survival as endpoint in the advanced cancer settingDouwe Postmus, Saskia Litiere, Jan Bogaerts, et al.
Plos One|December 12, 2017
Does access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patientsEliane Rohner, Michael Grabik, Thomy Tonia, et al.
The British Journal of Radiology|November 28, 2017
Commentary: how will interventional oncology navigate the "valleys of death" for new medical devices?Ricky A Sharma, Lucio Fumi, Riccardo A Audisio, et al.
European Journal of Cancer (Oxford, England : 1990)|August 16, 2025
Beyond traditional endpoints: A multi-state modelling approach to integrating morbidity and mortality in cancer treatments evaluationDouwe Postmus, Jan J Cornelissen, Jan Bogaerts, et al.
European Journal of Clinical Pharmacology|January 15, 2003
The review of drug applications submitted to the European Medicines Evaluation Agency: frequently raised objections, and outcomeFrancesco Pignatti, Bo Aronsson, Nick Gate, et al.
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