Primary endpoint adjudication: comparison between the expert committee and the regulatory MedDRA® coding in the MITRA‐FR study

Randomized trials are the gold standard for evaluating the efficacy and safety of drugs. Their main conclusions rely on the primary endpoint. An Endpoint Adjudication Committee (EAC) is set up in large trials to standardize diagnoses, and blindly assess events reported by investigators; this strategy is of particular interest for open-label trials (PROBE method: prospective randomized open with blind evaluation) and when there is a high risk of bias in the evaluation of the endpoints (complex or subjective events, composite outcomes, multicentre trials).1 The rate of reclassifications made by EACs compared to investigator notifications, and their impact on the trial results are unclear.2,3 Safety monitoring is a sponsor responsibility, regardless of the existence or not of an EAC. Serious adverse events (SAEs) reported by investigators are coded using the Medical Dictionary for Regulatory Activities (MedDRA®). This tool provides a rich and highly specific standardized medical terminology to facilitate communication, sharing, and