Working with the pharmaceutical industry in relation to paediatric clinical trials. A British perspective

Paediatric and Perinatal Drug Therapy

Volumn 8, Issue 4, 2008, Pages 140-144

  Dewit, Odile E ^a   Tiner, Richard ^b  

^a GLAXOSMITHKLINE   (United Kingdom)

^b ASSOCIATION OF THE BRITISH PHARMACEUTICAL INDUSTRY   (United Kingdom)

Author keywords

Children; Clinical trials; Pharmaceutical industry

Indexed keywords

NEW DRUG;

ARTICLE; CHILD; CHILD HEALTH CARE; CLINICAL PHARMACOLOGY; CLINICAL PROTOCOL; CLINICAL TRIAL; COOPERATION; DRUG EFFICACY; DRUG FORMULARY; DRUG FORMULATION; DRUG INDUSTRY; DRUG RESEARCH; DRUG SAFETY; EDUCATION PROGRAM; EUROPE; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; GOOD CLINICAL PRACTICE; GOOD MANUFACTURING PRACTICE; HEALTH CARE ACCESS; HEALTH CARE ORGANIZATION; HUMAN; MEDICAL EDUCATION; MEDICAL RESEARCH; NATIONAL HEALTH SERVICE; PATIENT PARTICIPATION; RESEARCH ETHICS; RISK BENEFIT ANALYSIS; UNITED KINGDOM;

EID: 49449084071     PISSN: 14630095     EISSN: None     Source Type: Journal    
DOI: 10.1185/146300908X254198     Document Type: Article

References (22)

1. Regulation (EC) No 1901/2006 Official Journal of the European Union L 378, 27.12.2006, p1-19.
2. Regulation (EC) No 1902/2006 Official Journal of the European Union L 378, 27.12.2006, p20-21.
3. Conroy S, Choonara I, Impicciatore P et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000;320: 79-82.
4. McIntyre J, Conroy S, Avery A et al. Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child 2000;83:498-501.
5. Conroy S, McIntyre J. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med 2005;10:115-122.
6. Shah SS, Hall M, Goodman DM et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med 2007;161:282-290.
7. Cras A, Conscience MA, Rajzbaum Get al. Off-label prescribing in a French hospital. Pharm World Sci 2007;29:97-100.
8. British National Formulary for Children. Martin J (Ed). British Medical Association, the Royal Pharmaceutical Society of Great Britain, the Royal College of Paediatrics and Child Health, and the Neonatal and Paediatric Pharmacists Group, London, BMJ Publishing Group Ltd, 2007.
9. Medicines for Children. Carson D (Ed). Royal College of Paediatrics and Child Health, Neonatal and Paediatric Pharmacists Group, London, 2003.
10. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice, E6 (R1). 1996. (http://www.ich.org/cache/compo/276-254-1.html) (Accessed 30 October 2007).
11. Murphy D. Update: USA Pediatric Drug Development, 2007. (http://www.fda.gov/oc/opt/presentations/LastVienna.ppt) (Accessed 30 October 2007).
12. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Clinical Investigation of Medicinal Products in the Pediatric Population, E11. 2000. (http://www.ich.org/cache/compo/276-254-1.html) (Accessed 30 October 2007).
13. Royal College of Paediatrics and Child Health. Safer and better medicines for children, developing the clinical and research base of paediatric pharmacology in the United Kingdom. 2004.
14. Choonara I, Dewit O, Harrop E et al. Training in paediatric clinical pharmacology in the UK. Br J Clin Pharmacol 2004;58:217-218.
15. (http://www.mcrn.org.uk).
16. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7. 2000. (http://www.ich.org/cache/compo/276-254-1.html) (Accessed on 30 October 2007).
17. Research and Development Directorate, Department of Health. Best Research for Best Health: A new national health research strategy. 2006. (http://www.dh.gov.uk/researchstrategy) (Accessed 30 October 2007).
18. (http://www.emea.europa.eu/htms/human/paediatrics/inventory.htm).
19. Directive 2001/20/EC. Official Journal of the European Communities L 121, 1.5.2001, p34-44.
20. Commission Directive 2005/28/ED. Official Journal of the European Union L91, 9.4.2005, p13-19.
21. NHS Research and Development Forum, NHS National Patient Safety Agency, NHS Research Ethics Service. Developing an Integrated Application System for Research. Bulletin - Issue 3. 2007. (http://www.rdforum.nhs.uk/docs/ Bulletin_Aug07.pdf) (Accessed 30 October 2007).
22. UKCRC. UK Health Departments agree to harmonise systems for permission for research. 19th September 2007 (http://www.ukcrc.org/publications/ news/streamliningrdpermissions.aspx).