Series: Pragmatic trials and real world evidence: Paper 5. Usual care and real life comparators
Open accessAbstract
Pragmatic trials may deliver real-world evidence on the added value of new medications compared with usual care and inform decision making earlier in development. This fifth paper in a series on pragmatic trials in the Journal discusses usual care as a comparator and the allocation of treatment strategies. The allocation and implementation of treatment strategies should resemble clinical practice as closely as possible. Randomization at the level of the site, as opposed to at the individual level, may be preferred. Data analysis according to the intention-to-treat principle is recommended, and crossover between treatment arms and strong treatment preferences may be accounted for in the study design in specific situations. Although usual care is the comparator of choice, this may differ substantially between centers and countries complicating comparator choice. Using clinical guidelines to define usual care can be helpful in standardizing comparator treatments; however, this may decrease the applicability of the results to real-life settings. Conversely, using multiple usual-care treatment arms will increase the complexity of the study. The specific objectives of the trial and design choices should be discussed with all stakeholders to realize the full potential of the pragmatic trial.
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- Authors
- Zuidgeest, M. G. P., Welsing, P. M. J., van Thiel, G. J. M. W., Ciaglia, A., Alfonso-Cristancho, R., Eckert, L., Eijkemans, M. J. C., & Egger, M.
- Affiliations
- University Medical Center Utrecht (NL)
- Sanofi (France) (FR)
- University of Bern (CH)
- Corresponding author
- Zuidgeest, Mira G.P.
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2017-10
- Volume
- 90
- Pages
- 92-98
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W2783576441
- Cited by
- 59
- References
- 44
- Citations by year
- 2026: 3 · 2025: 12 · 2024: 8 · 2023: 9 · 2022: 4 · 2021: 8 · 2020: 4 · 2019: 8 · 2018: 3
- FWCI
- 2.85
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Clinical Epidemiology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Bern Open Repository and Information System (University of Bern) (submittedVersion, cc-by-nc-nd)
- Open Access CRIS of the University of Bern
- Funders
- European Federation of Pharmaceutical Industries and Associations
- European Commission (115546)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Keywords
- pragmatic trials, usual care, real-world evidence, comparator selection, intention-to-treat analysis, crossover, treatment preferences, clinical guidelines, applicability, early drug development, stakeholder engagement
- MeSH terms
- Data Collection, Decision Making, Drug Therapy, Humans, Research Design, Randomized Controlled Trials as Topic, Practice Guidelines as Topic, Evidence-Based Medicine, Pragmatic Clinical Trials as Topic
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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