Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling Y Alvarez, A Hidalgo, F Maignen, J Slattery Drug safety 33, 475-487, 2010 | 98 | 2010 |
Comparing access to orphan medicinal products in Europe B Zamora, F Maignen, P O’Neill, J Mestre-Ferrandiz, M Garau Orphanet Journal of Rare Diseases 14, 1-12, 2019 | 93 | 2019 |
Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases F Maignen, M Hauben, E Hung, L Van Holle, JM Dogne Pharmacoepidemiology and drug safety 23 (2), 195-207, 2014 | 55 | 2014 |
Effective delivery of Complex Innovative Design (CID) cancer trials—a consensus statement SP Blagden, L Billingham, LC Brown, SW Buckland, AM Cooper, S Ellis, ... British journal of cancer 122 (4), 473-482, 2020 | 41 | 2020 |
A conceptual approach to the masking effect of measures of disproportionality F Maignen, M Hauben, E Hung, LV Holle, JM Dogne Pharmacoepidemiology and drug safety 23 (2), 208-217, 2014 | 26 | 2014 |
How should we assess the clinical and cost effectiveness of histology independent cancer drugs? S Cooper, JC Bouvy, L Baker, F Maignen, P Jonsson, P Clark, S Palmer, ... BMJ 368, 2020 | 25 | 2020 |
Late translational research: putting forward a new model for developing new anti‐cancer treatments that addresses the needs of patients and society D Lacombe, J Bogaerts, B Tombal, F Maignen, L Osipienko, R Sullivan, ... Molecular Oncology 13 (3), 558-566, 2019 | 15 | 2019 |
Modelling the time to onset of adverse reactions with parametric survival distributions: a potential approach to signal detection and evaluation F Maignen, M Hauben, P Tsintis Drug safety 33, 417-434, 2010 | 13 | 2010 |
A mathematical framework to quantify the masking effect associated with the confidence intervals of measures of disproportionality F Maignen, M Hauben, JM Dogné Therapeutic Advances in Drug Safety 8 (7), 231-244, 2017 | 12 | 2017 |
Addressing the dichotomy between individual and societal approaches to personalised medicine in oncology R Salgado, DB Solit, DL Rimm, J Bogaerts, R Canetta, T Lively, K Lyerly, ... European Journal of Cancer 114, 128-136, 2019 | 11 | 2019 |
Integrating health technology assessment requirements in the clinical development of medicines: the experience from NICE scientific advice F Maignen, L Osipenko, P Pinilla-Dominguez, E Crowe European journal of clinical pharmacology 73, 297-305, 2017 | 10 | 2017 |
Trends in early engagement between industry and HTA: analysis of scientific advice service provided by Nice since 2009 FM Maignen, L Osipenko, E Gajraj, R Chivers Value in Health 17 (7), A441, 2014 | 8 | 2014 |
A case of therapy-related myeloid neoplasm in a patient with Crohn’s disease treated with azathioprine F Mullier, JF Rahier, F Maignen, Y Cornet, C Graux, C Chatelain, ... Acta haematologica 128 (1), 1-6, 2012 | 7 | 2012 |
Comparing Access to Orphan Medicinal Products (OMPs) in the United Kingdom and other European countries B Zamora, F Maignen, PO Neill, J Mestre-Ferrandiz, M Garau OHE Consulting Report, 1-37, 2017 | 5 | 2017 |
Number needed to detect: nuances in the use of a simple and intuitive signal detection metric M Hauben, U Vogel, F Maignen Pharmaceutical Medicine 22, 13-22, 2008 | 4 | 2008 |
Regulatory watch: outcomes of early health technology assessment dialogues in medicinal product development F Maignen, L Osipenko, P Pinilla-Dominguez, E Crowe Nature Reviews Drug Discovery 16 (2), 79-80, 2017 | 3 | 2017 |
OP138 access to orphan drugs in the United Kingdom and other European countries B Zamora, M Garau, F Maignen, P O'Neill, J Mestre-Ferrandiz International Journal of Technology Assessment in Health Care 33 (S1), 64-65, 2017 | 3 | 2017 |
Assessing the Value of Nice Hta Scientific Advice on the Products Appraised by Nice: A Retrospective 10 Year Study F Maignen, J Kusel Value in Health 23, S529-S529, 2020 | 2 | 2020 |
Does serious consequential masking exist? An update M Hauben, F Maignen Pharmacoepidemiology and drug safety 26 (6), 727-729, 2017 | 2 | 2017 |
PDG69 Assessing the VALUE of Nice HTA Scientific Advice on the Products Appraised By Nice: A Retrospective 10 Year Study F Maignen, J Kusel Value in Health 23, S530, 2020 | 1 | 2020 |