Results 151 to 160 of about 5,536,836 (294)

Low‐intervention clinical trials in Spain: Do they progress?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Low‐Intervention Clinical Trials (LICTs) are generally pragmatic trials that investigate medicinal products already authorized for use. In 2014, simplified regulatory frameworks were introduced for LICTs with the aim of reducing regulatory burden and operational complexity, to foster non‐commercial clinical trials (NCCTs); the mandatory ...
Claudia Erika Delgado‐Espinoza   +4 more
wiley   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

String Figuring young children's perspectives of quality in English early childhood education and care

open access: yesBritish Educational Research Journal, EarlyView.
Abstract Quality in early childhood education and care (ECEC) is a contested concept and has generally been conceptualised by inter‐related indicators such as staff qualifications, educational environment, policy or child‐to‐staff ratios. There has been a more limited emphasis on how young children might perceive and experience quality.
Nikki Fairchild, Éva Mikuska
wiley   +1 more source

Making it explicit – Sustained shared thinking dialogue as a way to explore children's perspectives on quality in German early childhood education and care

open access: yesBritish Educational Research Journal, EarlyView.
Abstract To negotiate quality in early childhood education and care, we must ask from different perspectives what constitutes a good centre for children. The children themselves have only recently been identified as a resource to contribute to that discussion.
Katrin Macha   +4 more
wiley   +1 more source

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