The active comparator, new user study design in pharmacoepidemiology: historical foundations and contemporary application.
Open accessAbstract
Better understanding of biases related to selective prescribing of, and adherence to, preventive treatments has led to improvements in the design and analysis of pharmacoepidemiologic studies. One influential development has been the "active comparator, new user" study design, which seeks to emulate the design of a head-to-head randomized controlled trial. In this review, we first discuss biases that may affect pharmacoepidemiologic studies and describe their direction and magnitude in a variety of settings. We then present the historical foundations of the active comparator, new user study design and explain how this design conceptually mitigates biases leading to a paradigm shift in pharmacoepidemiology. We offer practical guidance on the implementation of the study design using administrative databases. Finally, we provide an empirical example in which the active comparator, new user study design addresses biases that have previously impeded pharmacoepidemiologic studies.
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Comparative effectiveness of denosumab vs alendronate among postmenopausal women with osteoporosis
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De novo vitamin D supplement use post-diagnosis is associated with breast cancer survival
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Risk of Breast Cancer With Prolactin Elevating Antipsychotic Drugs
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Incretin-Based Therapies and Diabetic Retinopathy: Real-World Evidence in Older U.S. Adults
Wang, T., Hong, J., Gower, E. W., Pate, V., Garg, S., Buse, J. B., & Stürmer, T. (2018) · Diabetes Care · doi:10.2337/dc17-2285 · Cited by 52 · see citing works
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Putting GLP-1 RAs and Thyroid Cancer in Context: Additional Evidence and Remaining Doubts
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Considerations on the use of different comparators in pharmacovigilance: A methodological review
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Methodologic Issues when Estimating Risks in Pharmacoepidemiology
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Immortal Time Bias in Epidemiology
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Comparison of Teriparatide and Denosumab in Patients Switching From Long-Term Bisphosphonate Use
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- Authors
- Lund, J. L., Richardson, D. B., & Stürmer, T.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Lund, Jennifer L.
- Venue
- Current Epidemiology Reports
- Published
- 2015-09-30
- Volume
- 2
- Issue
- 4
- Pages
- 221-228
- ISSN
- 2196-2995 (ISSN-L)
- PMC
- PMC4778958
- OpenAlex
- W1849521086
- Cited by
- 739
- References
- 42
- Citations by year
- 2026: 103 · 2025: 125 · 2024: 94 · 2023: 79 · 2022: 98 · 2021: 72 · 2020: 61 · 2019: 44 · 2018: 34 · 2017: 19 · 2016: 10
- FWCI
- 18.69
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Current Epidemiology Reports (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (2k12ca120780-16)
- National Institute on Aging (R01AG023178)
- National Cancer Institute (K12-CA120780)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK124723)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- bias in observational studies, head-to-head comparison, administrative databases
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