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...

ver descrição completa

Detalhes bibliográficos

Principais autores:	Louise F. Hill, Christina W. Obiero, Adrie Bekker, Ann Sarah Walker, Julia A. Bielicki, Mike Sharland, Francesca Schiavone
Formato:	Artigo
Idioma:	Inglês
Publicado em:	BMC 2025-02-01
coleção:	Trials
Assuntos:	Adverse events Safety Neonates Clinical trials
Acesso em linha:	https://doi.org/10.1186/s13063-025-08723-y
Tags:	Adicionar Tag Sem tags, seja o primeiro a adicionar uma tag!