Target trial emulation constitutes an important conceptual framework for increasing the validity of causal inference in observational pharmacoepidemiologic research and is now recommended by FDA, NICE and many other stakeholders to guide the design of comparative effectiveness-and safety studies. By considering the ideal enrolment criteria, treatment strategies, assignment procedures, outcome measures, causal contrasts, and statistical analysis of a hypothetical randomized controlled trial, many of the common pitfalls in the design and analysis of observational studies can be avoided.
One common pitfall in observational pharmacoepidemiology is immortal time bias: follow-up time during which the individual cannot experience the outcome of interest, which distorts the apparent effectiveness of treatment. This bias is avoided in randomized controlled trials since eligibility assessment, treatment assignment, and start of follow-up are all well-defined and in close conjunction. In the study published in GUT, the researchers (re-)assessed GLP1 non-initiators for study enrolment at the start of each calendar month, and sequentially emulated the target trial as a series of sepa[1]rate trials to ensure a well-defined time zero of the comparator group, minimizing the risk of immortal time bias.
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