When Emulating a Trial, Do as the Trialists Do: Missteps in Estimating Relative Effectiveness of a Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine Booster Dose.

Challenge

Target trial emulation methods require careful alignment between observational study design and the hypothetical trial being emulated, but common missteps remain frequent in real-world COVID-19 treatment effectiveness studies.

Solution

Target RWE researchers analyzed methodological errors in published observational COVID-19 treatment effectiveness studies and provided a corrective framework for rigorous target trial emulation.

Impact

Establishing clear methodological guardrails for trial emulation positions Target RWE as a methodological authority, directly supporting the credibility of its analyses in FDA submissions and pharma partner regulatory dossiers.