Completeness of protocols for clinical trials in children submitted to ethics committees-Reference-Cited by-同舟云学术

Completeness of protocols for clinical trials in children submitted to ethics committees

Published:2018-08-30 Issue:3 Volume:55 Page:291-298
ISSN:1034-4810
Container-title:Journal of Paediatrics and Child Health
language:en
Short-container-title:J Paediatr Child Health

Author:

Joseph Pathma D¹²,Caldwell Patrina HY¹³^ORCID,Barnes Elizabeth H⁴,Hynes Kay⁵,Choong Catherine S⁶⁷,Turner Sean⁸,Vosk Claire⁹,White Jessie¹⁰,Richichi Kate¹¹,Craig Jonathan C³¹²

Affiliation:

1. Discipline of Child and Adolescent Health; University of Sydney; Sydney New South Wales Australia

2. Pharmacy Department; Children's Hospital at Westmead; Sydney New South Wales Australia

3. Centre for Kidney Research; Children's Hospital at Westmead; Sydney New South Wales Australia

4. NHMRC Clinical Trials Centre; University of Sydney; Sydney New South Wales Australia

5. Pharmacy Department; Royal Children's Hospital; Melbourne Victoria Australia

6. Department of Diabetes and Endocrinology; Princess Margaret Hospital; Perth Western Australia Australia

7. School of Paediatrics and Child Health; University of Western Australia; Perth Western Australia Australia

8. Pharmacy Department; Women's and Children's Hospital; Adelaide South Australia Australia

9. Pharmacy Department; Monash Health; Melbourne Victoria Australia

10. Clinical Research and Education; Princess Margaret Hospital; Perth Western Australia Australia

11. Flinders Medical Centre and Repatriation General Hospital; Southern Adelaide Local Health Network; Adelaide South Australia Australia

12. School of Public Health; University of Sydney; Sydney New South Wales Australia

Funder

National Health and Medical Research Council Post-graduate scholarship

Publisher

Wiley

Subject

Pediatrics, Perinatology and Child Health

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/jpc.14189/fullpdf

Reference40 articles.

1. Assessment of risk of bias among pediatric randomized controlled trials;Crocetti;Pediatrics,2010

2. A systematic review of paediatric randomised controlled drug trials published in 2007;Aripin;Arch. Dis. Child.,2010

3. Controlled trials in children: Quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006;Thomson;PLoS One,2010

4. International Conference on Harmonisation Expert Working Group ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice (E6R1). 1996 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

5. World Health Organization Paediatric Clinical Trials Guidance for Assessors. 2011 http://www.who.int/childmedicines/CTguidance.pdf

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