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Low-risk trials for children and pregnant women threatened by unnecessary strict regulations. Does the coming EU Clinical Trial Regulation offer a solution?
Knaapen, Max; Ploem, Martine Corrette; Kruijt, Maya; Oudijk, Martijn A; van der Graaf, Rieke; Bet, Pierre M; Bakx, Roel; van Heurn, L W Ernst; Gorter, Ramon R; van der Lee, Johanna H.
Afiliação
  • Knaapen M; Department of Paediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. m.knaapen@amc.uva.nl.
  • Ploem MC; Department of Social Medicine, Section Health Law, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
  • Kruijt M; Department of Reproductive Medicine, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam and Stichting Zorgevaluatie Nederland, Amsterdam, The Netherlands.
  • Oudijk MA; Department of Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC, University of Amsterdam and Dutch Consortium for Healthcare Evaluation and Research in Obstetrics and Gynaecology, Amsterdam, The Netherlands.
  • van der Graaf R; Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
  • Bet PM; Department of Clinical Pharmacology and Pharmacy, VU University Medical Centre, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.
  • Bakx R; Department of Paediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
  • van Heurn LWE; Department of Paediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
  • Gorter RR; Department of Paediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
  • van der Lee JH; Paediatric Clinical Research Office, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Eur J Pediatr ; 179(8): 1205-1211, 2020 Aug.
Article em En | MEDLINE | ID: mdl-32535715
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Pesquisadores / Ensaios Clínicos como Assunto / Experimentação Humana Terapêutica / Regulamentação Governamental / União Europeia Tipo de estudo: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Limite: Child / Female / Humans / Pregnancy Idioma: En Revista: Eur J Pediatr Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Holanda
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Projetos de Pesquisa / Pesquisadores / Ensaios Clínicos como Assunto / Experimentação Humana Terapêutica / Regulamentação Governamental / União Europeia Tipo de estudo: Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Limite: Child / Female / Humans / Pregnancy Idioma: En Revista: Eur J Pediatr Ano de publicação: 2020 Tipo de documento: Article País de afiliação: Holanda