Target Trial Emulation Framework

Target Trial Emulation

Target trial emulation (TTE)-oriented study designs can improve real world evidence (RWE) acceptability, mitigate bias, evaluate clinically relevant treatment strategy, and overcome temporal challenges.

Observational studies in pharmacoepidemiology play a pivotal role in clinical decision-making when randomized controlled trials (RCT) are practically or ethically infeasible to conduct. The TTE framework is a structured approach that can be applied to observational studies to emulates the conditions and protocol of an ideal hypothetical RCT, addressing sources of bias. This approach is recommended by the U.S. Food and Drug Administration, European Medicines Agency, National Institute for Health and Care Excellence in the UK for observational studies with causal objectives to minimize the risk of bias.

“TTE is not just a technical tool, but a bridge to enhance the transparency and structure of RWE studies”
– Jetty Overbeek, Head of Research, PHARMO, part of Lumanity

Application of the TTE Framework
1. Select fit-for-purpose data: The right dataset can effectively support robust causal inference. Clinical richness is essential for capturing key covariates, such as patient demographics, comorbidities, and biomarkers, enabling accurate comparisons between treatment groups. Longitudinal depth tracks the conditions of each treatment strategy over time and accounts for time-varying confounders that influence outcomes. Data quality and completeness can minimize information bias and residual confounding.

2. Specify the target trial protocol and emulate it with real world data (RWD): The protocol should define the causal question of interest, eligibility criteria, treatment strategies, treatment assignment procedures, outcomes, follow-up, causal contrasts, and statistical analysis.

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