Elena Dudukina

Elena Dudukina

Consultant/Pharmacoepidemiologist

Danish Medicines Agency, Data Analytics Center

About me

I conduct research in pharmacoepidemiology and women’s health. I have experience in observational RWE/PAS studies of drugs and vaccines, especially, in pregnancy. I am passionate about causal inference methods and R stats.

Interests

  • Causal Inference
  • Pharmacoepidemiology (drug utilization, drug safety and efficacy)
  • Women’s health and reproductive epidemiology
  • R stats

Experience

 
 
 
 
 

Special consultant/Pharmacoepidemiologist

Danish Medicines Agency, Data Analytics Centre

Sep 2023 – Present Denmark

Responsibilities and tasks include:

  • Consulting on international RWE projects and large EMA international pilots (e.g., European Health Data Space use case)
  • Providing expertise on the prospectively collected administrative and healthcare database studies incl. regulatory assessment of RWE PASS studies
  • Leading role on internal taskforce for Danish registry data conversion to common data model
  • Design, execution and reporting of real-world evidence (RWE) pharmacoepidemiologic studies
  • Providing scientific and methodological input on various aspects of study design and conducted or planned analyses
  • Writing of study protocols, statistical analysis plans, study reports, scientific manuscripts
  • Developing presentations to conferences and stakeholder meetings
  • Project management and communication with internal and external stakeholders
  • Research student supervision and daily support
  • Organisation and planning of a yearly speaker event
  • Analytical support of ongoing projects and applied statistical data analyses for regulatory purposes
 
 
 
 
 

Clinical Specialist/postdoc

Aarhus University Hospital, Department of Clinical Epidemiology

Sep 2021 – Aug 2023 Denmark

Responsibilities include:

  • Design, execution and reporting of real-world evidence (RWE) pharmacoepidemiologic studies
  • Writing of study protocols, statistical analysis plans, study reports, scientific manuscripts
  • Providing scientific and methodological input on various aspects of study design and conducted or planned analyses
  • Creating abstracts, manuscripts and presentations
  • Project management

Skills include:

  • Using time-to-event modelling (Cox proportional hazards regression, Fine-Gray subdistribution hazard model), logistic regression, log-binomial regression, propensity-score based adjustment methods
  • Teaching incl. epidemiological designs and methods to Masters students overall covering > 200 hours
  • Data management, including complex cohort and variables ascertainment from various health and administrative databases, and statistical analyses involving PS adjustment methods (IPTW, ATT weighting, fine PS stratification, PS weighting, PS stratification, PS matching)
 
 
 
 
 

PhD in Epidemiology

Aarhus University, Department of Clinical Epidemiology

Jun 2018 – Jun 2021 Denmark

Responsibilities include:

  • Participating in development of the research protocols and statistical analyses plans for own and collaborative projects
  • Independent data management, incl. cohort and variables ascertainment from various Danish health and administrative databases
  • Statistical analyses
 
 
 
 
 

MSc in Biomedicine

Radboud University

Jan 2015 – Jan 2017 the Netherlands
MSc level courses in clinical epidemiology, epidemiology of infectious diseases, and statistics. Applied training during 6-months internship at Radboudumc and another 6-months external internship at Rijksinstituut voor Volksgezondheid en Milieu (RIVM).
 
 
 
 
 

MD (Preventive Medicine

First Moscow State Medical University

Jan 2008 – Jun 2015 Russia
Specialization in Medicine and Public Health; graduated with honors (magna cum laude)

Accomplish­ments

Threatened Abortion and Risk of Epilepsy, Cerebral Palsy and Attention-deficit/hyperactivity Disorder in Offspring: A Registry-based Cohort Study in Denmark. Authors: Elena Dudukina, Erzsébet Horváth-Puhó, Henrik Toft Sørensen, Vera Ehrenstein

International Society for Pharmacoepidemiology Sep 2020 – Dec 2020
Second Best Abstract (student)

Recent Posts

Direction of Bias From Nondifferential Misclassification

In this post, I simulate 3 scenarios of non-differential classifications of exposure as demonstrated in Yland et al., 2022: Specificity of exposure 90% and sensitivity 60% Specificity of exposure 90% and sensitivity 70% Specificity of exposure 90% and sensitivity 80% Each of these scenarios will be simulated in 10 thousand datasets of varying sizes: n=100, n=1000, n=10000.
2023-03-09 11 min read R

Competing events survival analyses

This is an account of R code by Paloma Rojas-Saunero, PhD available here, which I “translated” to tidyverse code and added some clarifications and figures. This is a longer read, but, hopefully, also is easier to follow for those who use tidyverse.
2022-11-24 25 min read R, causal methods

Using `WeightIt` R package for causal inference analyses

I recently discovered WeightIt R package and was very happy with its functionality and performance. I “delegated” my code computing IPTW to WeightIt and it was faster while producing the same results, as expected.
2022-07-20 20 min read R, simulation, methods, propensity score, IPTW, causal methods

Antibiotics utilization in Denmark: using R to solve practical tasks in epidemiology

Intro This is a blog post-chaperon for the R-Ladies meet-up Abuja. We are talking R in epidemiology, practical aspects of being R-user and going through data-supported example of how to use R for data aggregation and visualization.
2022-04-16 15 min read R, Meet-up, pharmacoepidemiology, drug utilization

Income inequality: OECD data

Data In this post I explore income inequality. The data comes from OECD, where inequality is defined as household disposable income per year. Main income inequality markers I use from the dataset are:
2022-01-10 7 min read R
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Recent Publications

Quickly discover relevant content by filtering publications.

Risk of diabetes and cardiovascular diseases in women with vaginal bleeding before 20 gestational weeks - Danish population-based cohort study

Women’s reproductive health is associated with cardiovascular morbidity. However, an association of vaginal bleeding (VB) in pregnancy …
Elena Dudukina, Erzsébet Horváth-Puhó, Henrik T. Sørensen, Vera Ehrenstein
DOI
Risk of diabetes and cardiovascular diseases in women with vaginal bleeding before 20 gestational weeks - Danish population-based cohort study

Association between vaginal bleeding in pregnancy that resulted in delivery and risk of cancer– a Danish registry-based cohort study

Vaginal bleeding (VB) before 20 gestational weeks of a viable pregnancy is a manifestation of a threatened miscarriage. VB is …
Elena Dudukina, Erzsébet Horváth-Puhó, Henrik T. Sørensen, Vera Ehrenstein
DOI
Association between vaginal bleeding in pregnancy that resulted in delivery and risk of cancer– a Danish registry-based cohort study

Association between pregnancy affected by vaginal bleeding and women's mortality – a Danish cohort study

We aimed to investigate the association between vaginal bleeding (VB) in pregnancy and women’s mortality, using VB-unaffected …
Elena Dudukina, Erzsébet Horváth-Puhó, Henrik T. Sørensen, Vera Ehrenstein
DOI
Association between pregnancy affected by vaginal bleeding and women's mortality – a Danish cohort study

Prenatal exposure to pregabalin, birth outcomes and neurodevelopment – a population‑based cohort study in four Nordic countries

Prenatal pregabalin exposure compared with no exposure showed a 1.1-fold association (95% CI 0.98–1.32) with the prevalence of any major congenital malformation among live and stillborn offspring, and a 1.7-fold association (95% CI 1.02–2.91) with stillbirth; the association was attenuated in Mantel–Haenszel meta-analysis for the latter outcome. We found no association between prenatal pregabalin exposure and risks of birth outcomes other than major congenital malformations or stillbirth. Prenatal exposure to pregabalin compared with no exposure to pregabalin and active comparators showed a 1.3-fold association (95% CI 1.03–1.63) with attention deficit/hyperactivity disorder; the association was attenuated in the analyses using active comparators and Mantel–Haenszel meta-analysis. There was no evidence of an association with other examined neurodevelopmental postnatal outcomes.
Elena Dudukina, Szimonetta Komjáthiné Szépligeti, Pär Karlsson, Kofi Asomaning, Anne Kjersti Daltveit, Katja Hakkarainen, Fabian Hoti, Helle Kieler, Astrid Lunde, Ingvild Odsbu, Matti Rantanen, Johan Reutfors, Laura Saarelainen, Vera Ehrenstein, Gunnar Toft
DOI

Risk of Major Cardiovascular and Cerebrovascular Events in Users of Lisdexamfetamine and Other Medications for Attention-Deficit Hyperactivity Disorder in Denmark and Sweden - A Population-Based Cohort Study

To our knowledge, this is the first population-based observational study using routinely collected administrative data from clinical practice to investigate the cardiovascular and cerebrovascular risk associated with exposure to LDX. Results of the current study suggest that there is little to no increased risk of cardiovascular and cerebrovascular events among patients treated with LDX compared with patients previously treated with other ADHD medications.
Joan Forns, Elena Dudukina, David Hägg, Péter Szentkúti, Karin Gembert, Estel Plana, Alicia Gilsenan, Erzsébet Horváth-Puhó, Vera Ehrenstein, Johan Reutfors, Cristina Rebordosa
DOI
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Popular Topics

ATC Cohort study Data analysis dataviz Denmark drug utilization epidemiology ggplot2 methods pharmacoepidemiology Real world evidence registry-based research Reproductive epidemiology Rstats RWE Sweden Threatened abortion tidyverse Vaginal bleeding in pregnancy Women's health

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