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H. Gardarsdottir · SciRah

Researcher profile · Semantic Scholar

H. Gardarsdottir

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H. Gardarsdottir — researcher profile on SciRah

h-index: 29
Works: 185
Citations: 2,967

Most-cited papers

Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective
A. de Jong, T. V. van Rijssel, Mira G. P. Zuidgeest, G. van Thiel +6 more
2022Clinical pharmacology and therapy109 citations Open access
Semantic Scholar
Risk of major bleeding among users of direct oral anticoagulants combined with interacting drugs: A population‐based nested case–control study
Yumao Zhang, P. Souverein, H. Gardarsdottir, H. A. van den Ham +2 more
2020British Journal of Clinical Pharmacology61 citations Open access
Semantic Scholar
Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019
S. Eskola, H. Leufkens, A. Bate, M. D. De Bruin +1 more
2021Clinical pharmacology and therapy46 citations Open access
Semantic Scholar
Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus.
Y. Santa-Ana-Téllez, Bart Lagerwaard, A. de Jong, H. Gardarsdottir +4 more
2023Drug Discovery Today42 citations Open access
Semantic Scholar
Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines
C. Willame, C. Dodd, R. Gini, C. Duran +33 more
202135 citations
Semantic Scholar
Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation
P. Souverein, H. A. van den Ham, C. Huerta, E. Merino +10 more
2020British Journal of Clinical Pharmacology33 citations Open access
Semantic Scholar
Drug exposure misclassification in pharmacoepidemiology: Sources and relative impact
Mirjam Hempenius, R. Groenwold, A. de Boer, O. Klungel +1 more
2021Pharmacoepidemiology and Drug Safety31 citations Open access
Semantic Scholar
New‐user and prevalent‐user designs and the definition of study time origin in pharmacoepidemiology: A review of reporting practices
K. Luijken, Judith J Spekreijse, M. van Smeden, H. Gardarsdottir +1 more
2021Pharmacoepidemiology and Drug Safety28 citations Open access
Semantic Scholar
Companies’ Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study
Ting Wang, N. McAuslane, L. Liberti, H. Gardarsdottir +2 more
2020Frontiers in Pharmacology28 citations Open access
Semantic Scholar
Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries.
D. Coppens, J. Hoekman, M. D. De Bruin, I. Slaper-Cortenbach +3 more
2020Cytotherapy26 citations Open access
Semantic Scholar
Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study
S. Abtahi, R. Pajouheshnia, Carlos E. Durán, J. Riera-Arnau +24 more
2023Drug Safety25 citations Open access
Semantic Scholar
A systematic review of how missing data are handled and reported in multi‐database pharmacoepidemiologic studies
N. Hunt, H. Gardarsdottir, M. Bazelier, O. Klungel +1 more
2021Pharmacoepidemiology and Drug Safety24 citations Open access
Semantic Scholar
Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population‐based cohort studies
H. A. van den Ham, P. Souverein, O. Klungel, R. Platt +13 more
2021Pharmacoepidemiology and Drug Safety24 citations Open access
Semantic Scholar
Which Benefits Can Justify Risks in Research?
T. V. van Rijssel, G. van Thiel, H. Gardarsdottir, J. V. van Delden
2024American Journal of Bioethics23 citations Open access
Semantic Scholar
Review of Studies Evaluating Effectiveness of Risk Minimization Measures Assessed by the European Medicines Agency Between 2016 and 2021
Renske J Grupstra, T. Goedecke, Jet Scheffers, Valerie Strassmann +1 more
2023Clinical pharmacology and therapy22 citations Open access
Semantic Scholar
Adherence to Direct Oral Anticoagulants in Patients With Non-Valvular Atrial Fibrillation: A Cross-National Comparison in Six European Countries (2008–2015)
M. Sabaté, X. Vidal, E. Ballarín, M. Rottenkolber +17 more
2021Frontiers in Pharmacology21 citations Open access
Semantic Scholar
Regulating advanced therapy medicinal products through the Hospital Exemption: an analysis of regulatory approaches in nine EU countries.
D. G. Coppens, H. Gardarsdottir, M. D. De Bruin, P. Meij +2 more
2020Regenerative medicine21 citations Open access
Semantic Scholar
A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
A. Suman, J. V. van Es, H. Gardarsdottir, D. Grobbee +5 more
2022Trials20 citations Open access
Semantic Scholar
The effect of non-adherence to antipsychotic treatment on rehospitalization in patients with psychotic disorders
H. Abdullah-Koolmees, S. Nawzad, T. Egberts, J. Vuyk +2 more
2021Therapeutic Advances in Psychopharmacology20 citations Open access
Semantic Scholar
Reporting of quality attributes in scientific publications presenting biosimilarity assessments of (intended) biosimilars: a systematic literature review.
Ali M Alsamil, T. Giezen, T. Egberts, H. Leufkens +3 more
2020European Journal of Pharmaceutical Sciences20 citations Open access
Semantic Scholar
The Role of Real-World Data and Evidence in Oncology Medicines Approved in EU in 2018-2019.
Sini M. Eskola, H. Leufkens, A. Bate, M. D. De Bruin +1 more
2023Journal of Cancer Policy19 citations Open access
Semantic Scholar
COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union
A. de Jong, Y. Santa-Ana-Téllez, G. van Thiel, Mira G. P. Zuidgeest +4 more
2021Clinical pharmacology and therapy19 citations Open access
Semantic Scholar
Describing diversity of real world data sources in pharmacoepidemiologic studies: The DIVERSE scoping review
R. Gini, R. Pajouheshnia, H. Gardarsdottir, Dimitri Bennett +16 more
2024Pharmacoepidemiology and Drug Safety18 citations Open access
Semantic Scholar
Implementation and performance of haemovigilance systems in 10 sub-saharan African countries is sub-optimal
W. Samukange, Verena Kluempers, M. Porwal, L. Mudyiwenyama +5 more
2021BMC Health Services Research17 citations Open access
Semantic Scholar
Tell me what you want, what you really really want: Estimands in observational pharmacoepidemiologic comparative effectiveness and safety studies
K. Luijken, R. van Eekelen, H. Gardarsdottir, Rolf H. H. Groenwold +1 more
2023Pharmacoepidemiology and Drug Safety16 citations Open access
Semantic Scholar
Opportunities and challenges for decentralized clinical trial approaches: European health technology assessment perspective.
A. de Jong, N. Shahid, Mira G. P. Zuidgeest, Y. Santa-Ana-Téllez +5 more
2023Value in Health16 citations Open access
Semantic Scholar
Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019–2020? A cross-sectional study in ClinicalTrials.gov
A. de Jong, Renske J Grupstra, Y. Santa-Ana-Téllez, Mira G. P. Zuidgeest +2 more
2022BMJ Open16 citations Open access
Semantic Scholar
Building HTA insights into the drug development plan: current approaches to seeking early scientific advice from HTA agencies.
Ting Wang, N. McAuslane, H. Gardarsdottir, W. Goettsch +1 more
2021Drug Discovery Today13 citations Open access
Semantic Scholar
Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review
R. Meijboom, H. Gardarsdottir, T. Egberts, T. Giezen
2021BioDrugs13 citations Open access
Semantic Scholar
Insights from the European Medicines Agency on digital health technology derived endpoints.
Keerti D. Jadoenathmisier, H. Gardarsdottir, Peter G. M. Mol, A. M. Pasmooij
2025Drug Discovery Today12 citations Open access
Semantic Scholar
Primary nonadherence to drugs prescribed by general practitioners: A Dutch database study
Mirjam Hempenius, Simone Rijken, R. Groenwold, K. Hek +3 more
2022British Journal of Clinical Pharmacology11 citations Open access
Semantic Scholar
Clinical Trials With Pragmatic Elements: A Review of Use Cases and Real‐World Data Utilization
L. Su, Lei Chen, Seema Betigeri, Nancy A. Dreyer +3 more
2025Clinical pharmacology and therapy10 citations Open access
Semantic Scholar
Real‐World Evidence to Inform Regulatory Decision Making: A Scoping Review
Marieke S. Jansen, O. Dekkers, S. le Cessie, L. Hooft +3 more
2024Clinical pharmacology and therapy10 citations Open access
Semantic Scholar
Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars
Ali M Alsamil, T. Giezen, T. Egberts, H. Leufkens +1 more
2021Pharmaceuticals10 citations Open access
Semantic Scholar
Bringing Trial Activities to Participants—The Trials@Home RADIAL Proof‐of‐Concept Trial Investigating Decentralization of Trials
M. Zuidgeest, Megan Heath, Bart Lagerwaard, Danny R. van Weelij +11 more
2025Clinical pharmacology and therapy9 citations Open access
Semantic Scholar
Unintended impact of pharmacovigilance regulatory interventions: A systematic review
Tomas Lasys, Y. Santa-Ana-Téllez, S. Siiskonen, R. Groenwold +1 more
2023British Journal of Clinical Pharmacology9 citations Open access
Semantic Scholar
Direct‐to‐participant investigational medicinal product supply in clinical trials in Europe: Exploring the experiences of sponsors, site staff and couriers
A. de Jong, Y. Santa-Ana-Téllez, Mira G. P. Zuidgeest, Renske J Grupstra +3 more
2023British Journal of Clinical Pharmacology9 citations Open access
Semantic Scholar
Indications related to antidepressant prescribing in the Nivel-PCD database and the SIDIAP database.
L. Camacho-Arteaga, H. Gardarsdottir, L. Ibañez, P. Souverein +5 more
2022Journal of Affective Disorders9 citations Open access
Semantic Scholar
Reoperation for bleeding following coronary artery bypass surgery with special focus on long-term outcomes
Steinthor A Marteinsson, Alexandra A Heimisdottir, T. Axelsson, Hera Johannesdottir +6 more
2020Scandinavian Cardiovascular Journal9 citations Open access
Semantic Scholar
Analytical Methods for Comparing Uncontrolled Trials with External Controls from Real-World Data: a Systematic Literature Review and Comparison to European Regulatory and Health Technology Assessment Practice.
M. Hogervorst, Kanaka Soman, H. Gardarsdottir, Wim G. Goettsch +1 more
2024Value in Health8 citations Open access
Semantic Scholar
Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021
Sharon C. M. Essink, Inge M. Zomerdijk, Sabine M. J. M. Straus, H. Gardarsdottir +1 more
2023Drug Safety8 citations Open access
Semantic Scholar
Switching TNFα inhibitors: Patterns and determinants
R. Meijboom, H. Gardarsdottir, M. Becker, M. D. de Groot +5 more
2021Pharmacology Research & Perspectives8 citations Open access
Semantic Scholar
Limitations Reported in Evaluating Effectiveness of Risk Minimization Measures in the EU during 2018–2021: A Qualitative Analysis of Industry‐Sponsored Post‐Authorization Safety Studies
Renske J Grupstra, Thomas Goedecke, H. Gardarsdottir
2024Clinical pharmacology and therapy7 citations Open access
Semantic Scholar
Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors
L. A. Minnema, T. Giezen, J. Hoekman, T. Egberts +2 more
2020Clinical pharmacology and therapy7 citations Open access
Semantic Scholar
Enabling appropriate use of antibiotics: review of European Union procedures of harmonising product information, 2007 to 2020
A. Opalska, M. Kwa, H. Leufkens, H. Gardarsdottir
2020Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin7 citations Open access
Semantic Scholar
Methods in dynamic treatment regimens using observational healthcare data: A systematic review
David Liang, Animesh Kumar Paul, Daniala L. Weir, V. Deneer +3 more
2025Comput. Methods Programs Biomed.6 citations Open access
Semantic Scholar
Multiple Perspectives on the Need for Real‐World Evidence to Inform Regulatory and Health Technology Assessment Decision‐Making: Scoping Review and Stakeholder Interviews
Marieke S. Jansen, O. Dekkers, S. le Cessie, L. Hooft +3 more
2025Pharmacoepidemiology and Drug Safety6 citations Open access
Semantic Scholar
Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study
M. Mollebaek, H. Gardarsdottir, A. Bikou, Ana Kodrič +13 more
2024Drug Safety6 citations Open access
Semantic Scholar
Incidence of and Reasons and Determinants Associated with Retransitioning from Biosimilar Etanercept to Originator Etanercept
R. Meijboom, H. Gardarsdottir, M. Becker, S. ten Wolde +2 more
2021BioDrugs6 citations Open access
Semantic Scholar
Are Further Interventions Needed to Prevent and Manage Hospital-Acquired Hyponatraemia? A Nationwide Cross-Sectional Survey of IV Fluid Prescribing Practices
P. Sindahl, C. Overgaard-Steensen, H. Wallach-Kildemoes, M. D. De Bruin +3 more
2020Journal of Clinical Medicine6 citations Open access
Semantic Scholar

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