Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation.

Wan, Mandy; Alessandrini, Elisa; Brogan, Paul; Eleftheriou, Despina; Warris, Adilia; Brüggemann, Roger; Turner, Mark

Wan, Mandy; Alessandrini, Elisa; Brogan, Paul; Eleftheriou, Despina; Warris, Adilia; Brüggemann, Roger; Turner, Mark.

Afiliação

Wan M; Pharmacy Department, Guy's and St Thomas' NHS Foundation Trust, Evelina London Children's Hospital, London, UK.
Alessandrini E; Institute of Pharmaceutical Science, King's College London, London, UK.
Brogan P; School of Pharmacy, University College London, London, UK.
Eleftheriou D; Institute of Child Health, University College London, London, UK.
Warris A; Institute of Child Health, University College London, London, UK.
Brüggemann R; Medical Research Council Centre for Medical Mycology at the University of Exeter, Exeter, UK.
Turner M; Department of Pharmacy and Radbound Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, The Netherlands.

Clin Trials ; 19(5): 573-578, 2022 10.

Article em En | MEDLINE | ID: mdl-35510580

Assuntos

Pesquisadores; Criança; União Europeia; Humanos; Preparações Farmacêuticas

Palavras-chave

Clinical trials directive; clinical trials regulation; paediatric investigator-initiated trial; risk-proportionate approach

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pesquisadores Tipo de estudo: Etiology_studies / Risk_factors_studies Limite: Child / Humans Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo

Imprimir

XML

PubMed Links

Buscar no Google