Synthetic and External Controls in Clinical Trials – A Primer for Researchers
Open accessAbstract
There has been a rapid expansion in the use of non-randomized evidence in the regulatory approval of treatments globally. An emerging set of methodologies have been utilized to provide greater insight into external control data used for these purposes, collectively known as synthetic control methods. Through this paper, we provide the reader with a set of key questions to help assess the quality of literature publications utilizing synthetic control methodologies. Common challenges and real-life examples of synthetic controls are provided throughout, alongside a critical appraisal framework with which to assess future publications.
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There is an increasing interest in the utilization of synthetic control methods (using external data to create controls).
“In this setting, there is an increasing interest in the utilization of synthetic control methods (that is, using external data to create controls).”
From Multimodal biomedical AI (2022) · cites this paper as [43]
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- Authors
- Thorlund, K., Dron, L., Park, J. J., & Mills, E. J.
- Affiliations
- McMaster University (CA)
- University of British Columbia (CA)
- Corresponding author
- Thorlund, Kristian
- Venue
- Clinical Epidemiology
- Publisher
- Informa UK Limited
- Published
- 2020-05
- Volume
- Volume 12
- Pages
- 457-467
- ISSN
- 1179-1349 (ISSN-L)
- PMC
- PMC7218288
- OpenAlex
- W3022623176
- Cited by
- 257
- References
- 29
- Citations by year
- 2026: 43 · 2025: 56 · 2024: 33 · 2023: 54 · 2022: 43 · 2021: 25 · 2020: 3
- FWCI
- 5.08
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Clinical Epidemiology (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- synthetic control method, causal inference, observational studies
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