Target trial emulation (TTE) is a causal inference framework for real-world research. It starts from a clearly defined causal question and emulates the rigorous design and procedures of randomized controlled trials (RCTs) to systematically reduce bias and enhance the validity of real-world evidence. According to research objectives, target trials can be classified as emulation or duplication. The emulation uses real-world data (RWD) and idealized RCTs designs to address causal questions lacking randomized evidence, whereas the duplication compares results between TTE and existing RCTs to assess concordance in regulatory conclusions, effect direction, and effect magnitude, thereby verifying data quality and methodological robustness. Increasing attention from regulatory agencies has underscored the potential of TTE in clinical decision-making, drug re-evaluation, and health policy assessment. However, despite the growing number of studies, many TTE applications show methodological heterogeneity, inconsistent design and analysis, and limited reporting transparency, which constrain their evidentiary value. This paper outlines the theoretical foundation and design principles of TTE, summarizes key analytical strategies and reporting standards, and presents representative applications to provide researchers with a practical framework for standardized and methodologically sound implementation of TTE in real-world studies.
Citation： LI Hao, LU Zhenzhen, LI Wenwen, WANG Mengyao, ZHAO Yang, HUANG Lihong. Target trial emulation: clinical applications and methodological standardization. Chinese Journal of Evidence-Based Medicine, 2026, 26(6): 705-710. doi: 10.7507/1672-2531.202511034 Copy
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