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Karen Chiswell

Statistical Scientist
Duke Clinical Research Institute
P.O. Box 17969, DUMC # 3850, Durham, NC 27715
Durham Center, 300 West Morgan Street, Durham, NC 27701

Overview


Ph.D., North Carolina State University - 2007

I work closely with clinical and quantitative colleagues to provide statistical leadership, guidance and mentoring on the design, execution, and analysis of clinical research studies. My work includes design and analysis of observational studies (including large cardiovascular registries, and clinical care databases linked with electronic health record data) and early-phase trials in pediatric populations. My statistical interests include study design, linear and non-linear mixed effects models, survival analysis, biology- and mechanism-based models, and statistical thinking and learning. 

Current Appointments & Affiliations


Recent Publications


Albiglutide and atrial fibrillation in patients with Type 2 diabetes and established cardiovascular disease: insights from the Harmony Outcomes trial.

Journal Article Eur J Prev Cardiol · January 6, 2026 AIMS: Atrial fibrillation and flutter (AF) are common in patients with Type 2 diabetes and are associated with worse outcomes. METHODS AND RESULTS: Harmony Outcomes was a multi-centre, event-driven, double-blind, placebo-controlled trial comparing the effe ... Full text Link to item Cite

Neonatal outcomes of pregnancy in women with congenital heart disease.

Journal Article Am Heart J · January 2026 BACKGROUND: Infants born to women with congenital heart disease (CHD) are at increased risk for adverse outcomes compared with the general population. There are few large, contemporary studies examining the relationship between CHD severity, maternal risk ... Full text Link to item Cite

Clinical and financial implications of inpatient and outpatient management of worsening heart failure.

Journal Article Eur J Heart Fail · November 2025 AIMS: Little is known regarding the clinical and financial implications of varying inpatient and outpatient management strategies for worsening heart failure (WHF). This analysis aimed to compare clinical outcomes, home-time, and healthcare expenditure fol ... Full text Link to item Cite
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Recent Grants


The North Carolina Congenital Heart Disease Surveillance Network

Public ServiceSenior Statistician · Awarded by Centers for Disease Control and Prevention · 2024 - 2029

Increasing the Quality and Efficiency of Clinical Trials (U18)

ResearchStatistician · Awarded by Food and Drug Administration · 2014 - 2029

Pharmacokinetic and pharmacodynamic study of montelukast in premature infants with BPD (PRISM)

ResearchStatistical Investigator · Awarded by National Institutes of Health · 2023 - 2028

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