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Journal Publications

2019

  • Klein, K., Hazell, L., Stolk, P. Shakir, S. The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK. In: Drug Safety, 2019.

2016

  • Vermeer NS, Ebbers HC, Straus SM, Leufkens HG, Egberts TC, De Bruin ML. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study. In: Pharmacoepidemiology and Drug Safety, 2016.
  • Klein K, Scholl JH, Vermeer NS, Broekmans AW, Van Puijenbroek EP, De Bruin ML, Stolk P. Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. In: Drug Safety, 2016.

2015

  • Klein K, De Bruin ML, Broekmans AW, Stolk P. Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers. In: BioDrugs, 2015.
  • Hoekman J, Boon WP, Bouvy JC, Ebbers HC, de Jong JP, De Bruin ML. Use of the conditional marketing authorization pathway for oncology medicines in Europe. In: Clinical Pharmacology & Therapeutics, 2015.
  • Ebbers HC, Langedijk J, Bouvy JC, Hoekman J, Boon WP, de Jong JP, De Bruin ML. An analysis of marketing authorisation applications via the mutual recognition and decentralised procedures in Europe. In: European Journal of Clinical Pharmacology, 2015.

2014

  • De Vries ST, Haaijer-Ruskamp FM, de Zeeuw D, Denig P. Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study. In: Health and quality of life outcomes, 2014.
  • De Vries ST, Haaijer-Ruskamp FM, de Zeeuw D, Denig P. The validity of a patient-reported adverse drug event questionnaire using different recall periods. In: Quality of life research, 2014.

2013

  • Bouvy JC, Ebbers HC, Schellekens H, Koopmanschap MA. The cost-effectiveness of Periodic Safety Update Reports (PSURs) for biologicals in Europe. In: Clinical Pharmacology & Therapeutics, 2013.
  • De Vries ST, Mol PG, De Zeeuw D, Haaijer-Ruskamp FM, Denig P. Development and initial validation of a patient-reported adverse drug event questionnaire. In: Drug Safety, 2013.
  • Ebbers HC, Al-Temimi E, Moors EH, Mantel-Teeuwisse AK, Schellekens H, Leufkens HGM. Differences between Post-Authorization adverse medicine reactions of biopharmaceuticals and small molecules. In: BioMedicines, 2013.
  • Ebbers HC, Crow SA, Vulto AG, Schellekens H. Who’s afraid of biosimilars? In: Nature Biotechnology, 2013.
  • Franken M, Koolman X. Health system goals: A discrete choice experiment to obtain societal valuations. In: Health Policy, 2013.
  • Franken M, Van Gils C, Gaultney J, Delwel G, Goettsch W, Huijgens P, Steenhoek A, Punt C, Koopman M, Redekop W, Uyl-de Groot C. Practical feasibility of outcomes research in oncology: lessons learned in assessing drug use and cost-effectiveness in The Netherlands. In: European Journal of Cancer, 2013.
  • Smink PA, Hoekman J, Grobbee DE, Eijkemans MJC, Parving H-H, Persson F, et al. A prediction of the renal and cardiovascular efficacy of aliskiren in ALTITUDE using short-term changes in multiple risk markers. In: European Journal of Preventive Cardiology, 2013.
  • Stefansdottir G, Zoungas S, Chalmers J, Knol MJ, Leufkens HG, Patel A, et al. The post-hoc use of randomized controlled trials to explore drug associated cancer outcomes: Methodological challenges. In: Current Drug Safety, 2013.
  • Beyer AR, Fasolo B, Phillips LD, De Graeff PA, Hillege HL. Risk perception of prescription drugs: Results of a survey among experts in the European regulatory network. In: Medical Decision Making, 2013.
  • Boessen R, Groenwold RH, Knol MJ, Grobbee DE, Roes KC. Comparing HAMD(17) and HAMD subscales on their ability to differentiate active treatment from placebo in randomized controlled trials. In: J Affect Disord, 2013; 145(3): 363-9.
  • De Jong JP, Grobbee DE, Flamion B, Forda SR, Leufkens HGM. Appropriate evidence for adaptive marketing authorization. In: Nature Reviews Drug Discovery, 2013.
  • Ebbers HC, Mantel-Teeuwisse AK, Sayed-Tabatabaei FA, Moors EH, Schellekens H, Leufkens HG. The role of Periodic Safety Update Reports in the safety management of biopharmaceuticals. In: Eur J Clin Pharmacol, 2013; 69(2): 217-26.
  • Wangge G, Roes KC, De Boer A, Hoes AW, Knol MJ. The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants. In: CMAJ, 2013; 185(3): 222-7.
  • Wangge G, Klungel OH, Roes KC, De Boer A, Hoes AW, Knol MJ. Should non-inferiority drug trials be banned altogether? In: Drug Discovery Today, 2013.

2012

  • Tervonen T, Van Valkenhoef G, Baştürk N, Postmus D. Hit-And-Run enables efficient weight generation for simulation-based multiple criteria decision analysis. In: European Journal of Operational Research, 2012.
  • Van Valkenhoef G, Lu G, De Brock B, Hillege HL, Ades AE, Welton NJ. Automating network meta-analysis. In: Research Synthesis Methods, 2012.
  • Van Valkenhoef G, Tervonen T, Zwinkels T, De Brock B, Hillege H. ADDIS: a decision support system for evidence-based medicine. In: Decision Support Systems, 2012.
  • Bernabe RD, Van Thiel GJ, Raaijmakers JA, Van Delden JJ. The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods. In: BMC Med Ethics, 2012; 13: 6,6939-13-6.
  • Boessen R, Groenwold RH, Knol MJ, Grobbee DE, Roes KC. Classifying responders and non-responders; does it help when there is evidence of differentially responding patient groups? In: J Psychiatr Res, 2012; 46(9): 1169-73.
  • Boessen R, Knol MJ, Groenwold RH, Grobbee DE, Roes KC. Increasing trial efficiency by early reallocation of placebo nonresponders in sequential parallel comparison designs: Application to antidepressant trials. In: Clin Trials, 2012; 9(5): 578-87.
  • Bouvy JC, Koopmanschap MA, Schellekens H. Value for money of medicine regulation. In: Expert Rev Pharmacoecon Outcomes Res, 2012; 12(3): 247-9.
  • Bouvy JC, Koopmanschap MA, Shah RR, Schellekens H. The cost-effectiveness of medicine regulation: the example of thorough QT/QTc studies. In: Clin Pharmacol Ther, 2012; 91(2): 281-8.
  • Cleemput I, Franken M, Koopmanschap MA, Le Polain M. European medicine reimbursement systems' legitimacy: five-country comparison and policy tool. In: Int J Technol Assess Health Care, 2012; 28(4): 358-66.
  • Ebbers HC, Crow SA, Vulto AG, Schellekens H. Interchangeability, immunogenicity and biosimilars. In: Nat Biotechnol, 2012; 30(12): 1186-90.
  • Ebbers HC, Mantel-Teeuwisse AK, Moors EH, SayedTabatabaei FA, Schellekens H, Leufkens HG. A cohort study exploring determinants of safety-related regulatory actions for biopharmaceuticals. In: Medicine Saf, 2012; 35(5): 417-27.
  • Ebbers HC, Muenzberg M, Schellekens H. The safety of switching between therapeutic proteins. In: Expert Opin Biol Ther, 2012; 12(11): 1473-85.
  • Ebbers HC, Pieters T, Leufkens HG, Schellekens H. Effective pharmaceutical regulation needs alignment with doctors. In: Medicine Discov Today, 2012; 17(3-4): 100-3.
  • Franken M, Le Polain M, Cleemput I, Koopmanschap M. Similarities and differences between five European medicine reimbursement systems. In: Int J Technol Assess Health Care, 2012; 28(4): 349-57.
  • Hernandez JF, Mantel-Teeuwisse AK, Van Thiel GJ, Belitser SV, Warmerdam J, De Valk V, et al. A 10-year analysis of the effects of media coverage of regulatory warnings on antidepressant use in The Netherlands and UK. In: PLoS One, 2012; 7(9): e45515.
  • Light DW, Lexchin JR. Pharmaceutical research and development: what do we get for all that money? In: BMJ, 2012; 344: e4348.
  • Macdougall IC, Roger SD, De Francisco A, Goldsmith DJ, Schellekens H, Ebbers H, Jelkmann W, London G, Casadevall N, Hörl WH, Kemeny DM, Pollock C. Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights. In: Kidney Int, 2012; 81(8):727-3.
  • Putzeist M, Heemstra HE, Garcia JL, Mantel-Teeuwisse AK, Gispen-De Wied CC, Hoes AW, et al. Determinants for successful marketing authorisation of orphan medicinal products in the EU. In: Medicine Discov Today, 2012; 17(7-8): 352-8.
  • Putzeist M, Mantel-Teeuwisse AK, Aronsson B, Rowland M, Gispen-de Wied CC, Vamvakas S, Hoes AW, Leufkens HG, Eichler HG. Factors influencing non-approval of new medicines in Europe. In: Nat Rev Medicine Discov, 2012; 11(12): 903-4.
  • Smink PA, Bakker SJ, Laverman GD, Berl T, Cooper ME, De Zeeuw D, et al. An initial reduction in serum uric acid during angiotensin receptor blocker treatment is associated with cardiovascular protection: a post-hoc analysis of the RENAAL and IDNT trials. In: J Hypertens, 2012; 30(5): 1022-8.
  • Smink PA, Lambers Heerspink HJ, Gansevoort RT, de Jong PE, Hillege HL, Bakker SJ, et al. Albuminuria, estimated GFR, traditional risk factors, and incident cardiovascular disease: The PREVEND (Prevention of Renal and Vascular Endstage Disease) Study. In: Am J Kidney Dis, 2012; 60(5): 804-11.
  • Stefansdottir G, Knol MJ, Arnardottir AH, Van der Elst ME, Grobbee DE, Leufkens HG, et al. Safety learning from medicines of the same class: room for improvement. In: Clin Pharmacol Ther, 2012; 91(5): 872-80.
  • Van der Baan FH, Bernabe RD, Bredenoord AL, Gregoor JG, Meynen G, Knol MJ, et al. Consent in psychiatric biobanks for pharmacogenetic research. In: Int J Neuropsychopharmacol, 2012: 1-6.
  • Van der Baan FH, Knol MJ, Klungel OH, Egberts AC, Grobbee DE, Roes KC. Potential of adaptive clinical trial designs in pharmacogenetic research. In: Pharmacogenomics, 2012; 13(5): 571-8.
  • Van der Baan FH, Knol MJ, Maitland-van der Zee AH, Regieli JJ, Van Iperen EP, Egberts AC, et al. Added value of pharmacogenetic testing in predicting statin response: results from the REGRESS trial. In: Pharmacogenomics J, 2012.
  • Van Valkenhoef G, Tervonen T, De Brock B, Hillege H. Deficiencies in the transfer and availability of clinical trials evidence: a review of existing systems and standards. In: BMC Med Inform Decis Mak, 2012; 12(1): 95.
  • Van Valkenhoef G, Tervonen T, De Brock B, Hillege HL. Algorithmic parameterization of mixed treatment comparisons. In: Statistics and Computing, 2012; 22(5): 1099-111.
  • Van Valkenhoef G, Tervonen T, Zhao J, De Brock B, Hillege HL, Postmus D. Multicriteria benefit-risk assessment using network meta-analysis. In: J Clin Epidemiol, 2012; 65(4): 394-403.

2011

  • Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, De Graeff PA, Mol PG. Effect of safety issues with HIV medicines on the approval process of other medicines in the same class: an analysis of European Public Assessment Reports. In: Medicine Saf, 2011; 34(11): 1101-14.
  • Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, Eichler HG, De Graeff PA, Mol PG. Additional safety risk to exceptionally approved medicines in Europe? In: Br J Clin Pharmacol, 2011; 72(3): 490-9.
  • Bernabe RD, Van Thiel GJ, Raaijmakers JA, Van Delden JJ. Is informed consent necessary for randomized Phase IV 'observational' drug studies? In: Drug Discov Today, 2011; 16(17-18): 751-4.
  • Bernabe RD, Van Thiel GJ, Van Delden JJ, Raaijmakers JA. Informed consent and phase IV non-interventional medicine research. In: Curr Med Res Opin, 2011; 27(3): 513-8.
  • Boessen R, Knol MJ, Groenwold RH, Roes KC. Validation and predictive performance assessment of clinical trial simulation models. In: Clin Pharmacol Ther, 2011; 89(4): 487,8; author reply 488.
  • Bouvy JC, Weemers J, Schellekens H, Koopmanschap MA. Willingness to pay for adverse medicine event regulatory actions. In: Pharmacoeconomics, 2011; 29(11): 963-75.
  • Ebbers HC, Mantel-Teeuwisse AK, Moors EH, Schellekens H, Leufkens HG. Today's challenges in pharmacovigilance: what can we learn from epoetins? In: Medicine Saf, 2011; 34(4): 273-87.
  • Hakobyan L, Haaijer-Ruskamp FM, De Zeeuw D, Dobre D, Denig P. A review of methods used in assessing non-serious adverse medicine events in observational studies among type 2 diabetes mellitus patients. In: Health Qual Life Outcomes, 2011; 9: 83.
  • Hakobyan L, Haaijer-Ruskamp FM, De Zeeuw D, Dobre D, Denig P. Comparing adverse event rates of oral blood glucose-lowering medicines reported by patients and healthcare providers: a post-hoc analysis of observational studies published between 1999 and 2011. In: Medicine Saf, 2011; 34(12): 1191-202.
  • Hernandez J, Mantel-Teeuwisse AK, Van Thiel GJ, Belitser SV, Raaijmakers J, Pieters T. Publication trends in newspapers and scientific journals for SSRIs and suicidality: a systematic longitudinal study. In: BMJ Open, 2011; 1(2).
  • Miao Y, Dobre D, Heerspink HJ, Brenner BM, Cooper ME, Parving HH, et al. Increased serum potassium affects renal outcomes: a post hoc analysis of the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) trial. In: Diabetologia, 2011; 54(1): 44-50.
  • Miao Y, Ottenbros SA, Laverman GD, Brenner BM, Cooper ME, Parving HH, et al. Effect of a reduction in uric acid on renal outcomes during losartan treatment: a post hoc analysis of the reduction of endpoints in non-insulin-dependent diabetes mellitus with the Angiotensin II Antagonist Losartan Trial. In: Hypertension, 2011; 58(1): 2-7.
  • Miao Y, Smink PA, De Zeeuw D, Lambers Heerspink HJ. Drug-induced changes in risk/biomarkers and their relationship with renal and cardiovascular long-term outcome in patients with diabetes. In: Clin Chem, 2011; 57(2): 186-95.
  • Philips L, Fasolo B, Zafiropoulos N, Beyer A. Is quantitative benefit–risk modelling of medicines desirable or possible? In: Drug Discovery Today: Technologies, 2011; 8(1): e3-e10.
  • Putzeist M, Mantel-Teeuwisse AK, Gispen-De Wied CC, Hoes AW, Leufkens HG. Regulatory scientific advice in medicine development: does company size make a difference? In: Eur J Clin Pharmacol, 2011; 67(2): 157-64.
  • Smink PA, Miao Y, De Zeeuw D, Lambers Heerspink HJ. Drug-induced changes in risk/biomarkers and their relationship with renal and cardiovascular long-term outcome in patients with diabetes. In: Clin Chem, 2011; 57(2): 186-95.
  • Steenhoek A, Koopmanschap MA, Franken MG, Rutten FF. New medicines: money-back guarantee? In: Ned Tijdschr Geneeskd, 2011; 155: A2042.
  • Stefansdottir G, De Bruin ML, Knol MJ, Grobbee DE, Leufkens HG. Randomized controlled trials of COX-2 inhibitors: an analysis of doses used and trends over time to investigate implications for comparative safety. In: Medicine Saf, 2011; 34(9): 783-92.
  • Stefansdottir G, Zoungas S, Chalmers J, Kengne AP, Knol MJ, Leufkens HG, Patel A, Woodward M, Grobbee DE, De Bruin ML. Intensive glucose control and risk of cancer in patients with type 2 diabetes. In: Diabetologia, 2011; 54(7): 1608-14.
  • Tervonen T, Van Valkenhoef G, Buskens E, Hillege HL, Postmus D. A stochastic multicriteria model for evidence-based decision making in medicine benefit-risk analysis. In: Stat Med, 2011; 30(12): 1419-28.
  • Van der Baan FH, Klungel OH, Egberts AC, Leufkens HG, Grobbee DE, Roes KC, et al. Pharmacogenetics in randomized controlled trials: considerations for trial design. In: Pharmacogenomics, 2011; 12(10): 1485-92.
  • Van Valkenhoef G, Tervonen T, De Brock B, Postmus D. Quantitative release planning in extreme programming. In: Information and Software Technology, 2011; 53(11): 1227-35.
  • Vlaar PJ, Mahmoud KD, Holmes DR,Jr, Van Valkenhoef G, Hillege HL, Van der Horst IC, et al. Culprit vessel only versus multivessel and staged percutaneous coronary intervention for multivessel disease in patients presenting with ST-segment elevation myocardial infarction: a pairwise and network meta-analysis. In: J Am Coll Cardiol, 2011; 58(7): 692-703.

2010

  • Van Valkenhoef G. Product and release planning practices for extreme programming. Chapter in: Agile processes in software engineering and extreme programming. Lecture Notes in Business Information Processing, 2010; 48(Part 2): 238-43.
  • Wangge G, Klungel OH, Roes KC, De Boer A, Hoes AW, Knol MJ. Interpretation and inference in noninferiority randomized controlled trials in medicine research. In: Clin Pharmacol Ther, 2010; 88(3): 420-3.
  • Wangge G, Klungel OH, Roes KC, De Boer A, Hoes AW, Knol MJ. Room for improvement in conducting and reporting non-inferiority randomized controlled trials on medicines: a systematic review. In: PLoS One, 2010; 5(10): e13550.

2009

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