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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


Clinical Effectiveness of Sodium-Glucose Cotransporter-2 Inhibitors Among Older Patients Hospitalized for Heart Failure With Reduced Ejection Fraction.

Journal Article J Am Heart Assoc · May 19, 2026 BACKGROUND: SGLT2 (sodium-glucose cotransporter-2) inhibitors (SGLT2i) reduce cardiovascular events in randomized controlled trials of patients with heart failure with reduced ejection fraction (HFrEF), but these trials enrolled outpatient, relatively youn ... Full text Link to item Cite

Predictors of ischemic stroke and major bleeding among patients with atrial fibrillation in clinical practice.

Journal Article Am Heart J · May 19, 2026 BACKGROUND: Numerous risk scores exist to quantify the risk of ischemic stroke risk in patients with atrial fibrillation or flutter (AF/AFL). However, how these tools perform in cohorts or those already on oral anticoagulation (OAC) therapy is unclear. MET ... 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

View All Grants