Hill, Louise; Obiero, Christina; Bekker, Adrie; Walker, Ann; Bielick, Julia; Sharland, Michael; Schiavone, Francesca; (2025) Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches. Trials , 26 , Article 46. 10.1186/s13063-025-08723-y.

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Abstract

Adverse event (AE) collection is a key part of evidence generation in clinical trials and an integral element of safety reporting. AE assessment and documentation is particularly challenging in neonates who are a heterogeneous population with high rates of co-morbidities. Neonatal research is finally gaining the attention of regulators regarding drug development and the need for optimal dosing specific to this population. However, further efforts are necessary to ensure that adverse events (AEs) are adequately collected, allowing for the generation of essential safety data. It is also crucial that the methodology used aligns with the intended trial outcomes to minimise the burden on trial sites. In resource-constrained settings, where pharmacovigilance implementation can be particularly challenging, a pragmatic approach to safety reporting is even more important given the significant public health need for effective drugs. This commentary reflects on some of the challenges and potential areas of improvement in safety reporting that could be addressed in future neonatal-focused trials.

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