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Safety reporting in neonatal clinical trials: reflections towards optimal, globally relevant approaches

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...

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Main Authors: Louise F. Hill, Christina W. Obiero, Adrie Bekker, Ann Sarah Walker, Julia A. Bielicki, Mike Sharland, Francesca Schiavone
Format: Artigo
Language:Inglês
Published: BMC 2025-02-01
Series:Trials
Subjects:
Adverse events
Safety
Neonates
Clinical trials
Online Access:https://doi.org/10.1186/s13063-025-08723-y
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