CORS Publications

List of scientific publications by CORS affiliated authors

Sorted by publication date, most recent

Preparation of Direct Healthcare Professional Communication: An Exploratory Study on the Experiences and Perceptions of European Pharmaceutical Companies and the EMA
Boskovic, A., Møllebæk, M., Kaae, S.
Therapeutic Innovation & Regulatory Science, Sept. 2019

Danish Physicians’ Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study
Sachs, M.L., Colding-Jørgensen, M., Helboe, P. et al.
Pharmaceutical Medicine, 2019, 33:99.

How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations.
Hansen, M. B., Nørgaard, L. S., & Hallgreen, C. E. (2019).
Therapeutic Innovation & Regulatory Science., 2019.

Incidence of Direct Oral Anticoagulant use in patients with non-valvular atrial fibrillation and characteristics of users in six European countries (2008-2015): A cross-national drug utilization study.
Ibáñez, L, Sabaté, M,Vidal, X, et al.
British Journal of Clinical Pharmacology, 2019.

Body of evidence and approaches applied in the clinical development program of fixed‐dose combinations in the European Union from 2010‐2016
A.Nøhr‐Nielsen, M.L.De Bruin,M.Thomsen,C.B.Pipper,T.Lange,O.J.Bjerrum,T.M.Lund
British Journal of Clinical Pharmacology. 11 May 2019.

The EU regulatory landscape of non-biological complex drugs (NBCDs) follow-on products: Observations and recommendations
K.Klein, P.Stolk, M.L.De Bruin, H.G.M.Leufkens, D.J.A.Crommelin, J.S.B.De Vlieger
European Journal of Pharmaceutical Sciences, Volume 133, 2019, Pages 228-235.

Adjusting for unmeasured confounding using validation data: Simplified two‐stage calibration for survival and dichotomous outcomes
Vidar Hjellvik  Marie L. De Bruin  Sven O. Samuelsen  Øystein Karlstad  Morten Andersen  Jari Haukka  Peter Vestergaard  Frank de Vries  Kari Furu
Wiley Online Library. 2019 March.
doi: 10.1002/sim.8131

Genetic susceptibility to radiation-induced breast cancer after Hodgkin Lymphoma
Annemieke W.J. Opstal-van Winden, Hugoline G. de Haan, Michael Hauptmann, Marjanka K. Schmidt, Annegien Broeks, Nicola S. Russell, Cécile P.M. Janus, Augustinus D.G. Krol, Frederieke H. van der Baan, Marie L. De Bruin, Anna M. van Eggermond, Joe Dennis, Hoda Anton Culver, Christopher A. Haiman, Elinor J. Sawyer, Angela Cox, Peter Devilee, Maartje J. Hooning, Julian Peto, Fergus J. Couch, Paul Pharoah, Nick Orr, Douglas F. Easton, Berthe M.P. Aleman, Louise C. Strong, Smita Bhatia, Rosie Cooke, Leslie L. Robison, Anthony J. Swerdlow and Flora E. van Leeuwen
Blood 2018 :blood-2018-07-862607;

The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies
Møllebæk M,  Kaae S, De Bruin ML, Torbjörn C, Sukhwinder J, Hallgreen, CE.
Res Social Adm Pharm, 2018 June 21

Post‐authorisation changes to specific obligations of conditionally authorised medicines in the EU: a retrospective cohort study
Bloem LT, Mantel‐Teeuwisse AK, Leufkens HGM, De Bruin ML, Klungel OH, Hoekman J.
Generic Drugs. 2019 Feb;105(2):426-435
doi: 10.1002/cpt.1169

Identifying Off-Label Prescriptions Through Data Mining in Danish Community Pharmacy Servers: An Exploratory Study on Desmopressin, Diclofenac, Fucidin, Mirtazapine and Quetiapine.
Andrulyte M, Bjerrum OJ.
Basic & Clinical Pharmacology & Toxicology. 2018;123:155-160
Doi: 10.1111/bcpt.13009 [Epub ahead of print]

A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
Coppens DGM, de Wilde S, Guchelaar HJ, De Bruin ML, Leufkens HGM, Meij P,
Hoekman J. Cytotherapy. 2018 Jun;20(6):769-778

EU decision-making for marketing authorization of advanced therapy medicinal products: a case study
de Wilde S, Coppens DGM, Hoekman J, De Bruin ML, Leufkens HGM, Guchelaar HJ, Meij P.
Drug Discovery Today. 2018 Jul;23(7):1328-1333

The association of diabetes mellitus and insulin treatment with expression of insulin-related proteins in breast tumors.
Bronsveld HK, De Bruin ML, Wesseling J, Sanders J, Hofland I, Jensen V, Bazelier MT, ter Braak B, de Boer A, Vestergaard, Schmidt MK.
BMC Cancer, 2018;18:224.

Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
Kurz X, Perez-Gutthann S, the ENCePP Steering Group 2017-2019 (Apostolidis K, Arlett P, Candore G, De Bruin ML, De Vries C, Duarte D, Ehrenstein V, Eichler HG, Gini R, Herdeiro T, Hillege JL, Klungel OH, Kurz X, Le Louet H, MacDonald TM, Mazzaglia G, Moride Y, Slattery J, Trifiro G, Verpillat P).
Pharmacoepidemiol Drug Saf. 2018 Mar;27(3):245-252

Differences and similarities in medicine use, perceptions and sharing among adolescents in two different educational settings.
Vestergaard S, Ravn P, Erikstrup Hallgreen C, Kaae S.
Int J of Adoles Med Health. 2017 Nov 23.
doi:10.1515/ijamh-2017-0097 [Epub ahead of print]

Evidence synthesis in drug safety assessment: the example of rosiglitazone.
Rietbergen C, Stefansdottir G, Leufkens HG, Knol MJ, De Bruin ML, Klugkist I.
Front Med. 2018 Feb;4:228.
doi: 10.3389/fmed.2017.00228 

Global regulatory differences for gene and cell based therapies: consequences and implications for patient access and therapeutic innovation.
Coppens DGM, De Bruin ML, Leufkens HGM, Hoekman J.
Clin Pharmacol Ther. 2018 Jan;103(1):120-127. 
doi: 10.1002/cpt.894.

When more is less - An exploratory study of the precautionary reporting bias and its impact on safety signal detection
Klein K, Scholl JHG, De Bruin ML, van Puijenbroek EP, Leufkens HGM, Stolk P. 
Clin Pharmacol Ther. 2018 Feb;103(2):296-303. 
doi: 10.1002/cpt.879.   

Breast Cancer Risk After Radiation Therapy for Hodgkin Lymphoma: Influence of Gonadal Hormone Exposure
Krul IM, Opstal-van Winden AWJ, Aleman BMP, Janus CPM, van Eggermond AM, De Bruin ML, Hauptmann M, Krol ADG, Schaapveld M, Broeks A, Kooijman KR, Fase S, Lybeert ML, Zijlstra JM, van der Maazen RWM, Kesminiene A, Diallo I, de Vathaire F, Russell NS, van Leeuwen FE. 
Int J Radiat Oncol Biol Phys. 2017 Nov;99(4):843-853.
doi: 10.1016/j.ijrobp.2017.07.016.

Risk Perceptions in Diabetic Patients Who Have Experienced Adverse Events: Implications for Patient Involvement in Regulatory Decisions.
Lindskov Sachs M, Kälvemark Sporrong S, Colding-Jørgensen M, Frokjaer S, Helboe P, Jelic K, Kaae S.
Pharm Med. 2017 Aug;31(4):245-255.
doi: 10.1007/s40290-017-0200-z.

Infradiaphragmatic irradiation and high procarbazine doses increase colorectal cancer risk in Hodgkin lymphoma survivors.
van Eggermond AM, Schaapveld M, Janus CP, de Boer JP, Krol AD, Zijlstra JM, van der Maazen RW, Kremer LC, van Leerdam ME, Louwman MW, Visser O, De Bruin ML, Aleman BM, van Leeuwen FE.
Br J Cancer. 2017 Jul 25;117(3):306-314. 
doi: 10.1038/bjc.2017.177.

Cancer risk among insulin users: comparing analogues with human insulin in the CARING five-country cohort study.
But A, De Bruin ML, Bazelier MT, Hjellvik V, Andersen M, Auvinen A, Starup-Linde J, Schmidt MK, Furu K, de Vries F, Øystein Karlstad Ø, Ekström N, Haukka J.
Diabetologia. 2017 Sep;60(9):1691-1703.

Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data.
Nyeland ME, Laursen MV, Callréus T.
Pharmacoepidemiol Drug Saf. 2017 Jun;26(6):607-614. 
doi: 10.1002/pds.4203.

Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013
Bouvy JC, Blake K, Slattery J, De Bruin ML, Arlett P, Kurz X. 
Pharmacoepidemiol Drug Saf. 2017 Dec;26(12):1442-1450.  

Trends in breast cancer incidence among women with type-2 diabetes in British general practice
Bronsveld HK, Peeters PJ, de Groot MC, de Boer A, Schmidt MK, De Bruin ML. 
Prim Care Diabetes. 2017 Aug;11(4):373-382.
doi: 10.1016/j.pcd.2017.02.001. 

Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight
Engel P, Almas MF, De Bruin ML, Starzyk K, Blackburn S, Dreyer NA. 
Br J Clin Pharmacol. 2017 Apr;83(4):884-893. 
doi: 10.1111/bcp.13165. 

Serious adverse events reported for antiobesity medicines: postmarketing experiences from the EU adverse event reporting system EudraVigilance
Aagaard L, Hallgreen CE, Hansen EH. 
Int J Obes (Lond). 2016 Nov;40(11):1742-1747. 
doi: 10.1038/ijo.2016.135. 

A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary
Borup G, Bach KF, Schmiegelow M, Wallach-Kildemoes H, Bjerrum OJ, Westergaard N.
Ther Innov Regul Sci. 2016 May;50(3):304-311.  
doi: 10.1177/2168479015622668.   

Recommendations for benefit-risk assessment methodologies and visual representations.
Hughes D, Waddingham E, Mt-Isa S, Goginsky A, Chan E, Downey GF, Hallgreen CE, Hockley KS, Juhaeri J, Lieftucht A, Metcalf MA, Noel RA, Phillips LD, Ashby D, Micaleff A; PROTECT Benefit-Risk Group. 
Pharmacoepidemiol Drug Saf. 2016 Mar;25(3):251-62. 
doi: 10.1002/pds.3958. 

Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education
Spindler P, Bach KF, Schmiegelow M, Bedlington N, Eichler HG. 
Ther Innov Regul Sci. 2016 Jan;50(1):44-48. 
doi: 10.1177/2168479015599810.