Academic Journal
Practical elements to consider when emulating a target trial.
| Title: | Practical elements to consider when emulating a target trial. |
|---|---|
| Authors: | Tran VT; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France. Electronic address: thi.tran-viet@aphp.fr., Porcher R; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France., Perrodeau E; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France., Yaacoub S; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France., Boutron I; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France., Ravaud P; Center for Research in Epidemiology and Statistics (CRESS), Université Paris Cité and Université Sorbonne Paris Nord, INSERM, INRAE, Paris F-75004, France; Centre d'Epidemiologie clinique, AP-HP, Hôpital Hôtel Dieu, Paris F-75004, France; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York City, NY, USA. |
| Source: | Journal of clinical epidemiology [J Clin Epidemiol] 2026 Jun; Vol. 194, pp. 112205. Date of Electronic Publication: 2026 Feb 27. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Elsevier Country of Publication: United States NLM ID: 8801383 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5921 (Electronic) Linking ISSN: 08954356 NLM ISO Abbreviation: J Clin Epidemiol Subsets: MEDLINE |
| Imprint Name(s): | Publication: New York : Elsevier Original Publication: Oxford ; New York : Pergamon Press, c1988- |
| MeSH Terms: | Randomized Controlled Trials as Topic*/methods , Observational Studies as Topic*/methods , Research Design*, Humans ; Bias |
| Abstract: | Background and Objectives: Target trial emulation, i.e., the analysis of observational data by explicitly emulating the design components of a randomized controlled trial (RCT), has gained attention in recent years as an approach to estimate causal effects of pharmacological or nonpharmacological interventions that are, on average, similar to those of RCTs. Methods: This article addresses 2 objectives. First, we examine factors that may explain discrepancies in treatment effect estimates between RCTs and their target trial emulations, beyond issues related to bias or imperfect replication of the original trial. Second, we outline 11 practical considerations for the design and planning of a target trial emulation. Results: Treatment effect estimates from RCTs and their target trial emulations may differ because of differences in the underlying populations (beyond formal eligibility criteria), the definition of interventions, the measurement and definition of outcomes, and the causal estimand being targeted. To improve the validity of target trial emulations, several design elements should be considered. For example, control and intervention groups should be concomitant and geographically comparable, and temporal changes in clinical practice should be accounted for. Also, when grace periods are used, they should reflect logistical delays in treatment initiation while maintaining assignment at time zero. Finally, emulations necessitate adequate sample size and sufficiently rich data to address imbalances in prognostic factors. Conclusion: This article provides key elements to consider when planning a target trial emulation. (Copyright © 2026 The Author(s). Published by Elsevier Inc. All rights reserved.) |
| Competing Interests: | Declaration of competing interest None. |
| Contributed Indexing: | Keywords: Bias; Conduct; Estimands; Observational studies; Randomized controlled trials; Target trial emulation |
| Entry Date(s): | Date Created: 20260301 Date Completed: 20260709 Latest Revision: 20260709 |
| Update Code: | 20260711 |
| DOI: | 10.1016/j.jclinepi.2026.112205 |
| PMID: | 41765347 |
| Database: | MEDLINE |
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