메뉴 건너뛰기




Volumn 97, Issue 6, 2012, Pages 561-563

Ethics bureaucracy: A significant hurdle for collaborative follow-up of drug effectiveness in rare childhood diseases

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; CRYOPYRIN;

EID: 84861480604     PISSN: 00039888     EISSN: 14682044     Source Type: Journal    
DOI: 10.1136/archdischild-2011-301175     Document Type: Editorial
Times cited : (13)

References (15)
  • 1
    • 0034728799 scopus 로고    scopus 로고
    • Use of unlabelled and off licence drugs in children (multiple letters)
    • Ruperto N, Martini A. Use of unlabelled and off licence drugs in children. A European paediatric rule is needed to protect children. BMJ 2000;320:1210-11. (Pubitemid 30224281)
    • (2000) British Medical Journal , vol.320 , Issue.7243 , pp. 1210-1211
    • Riordan, F.A.I.1    Ruperto, N.2    Martini, A.3
  • 2
    • 33947432434 scopus 로고    scopus 로고
    • Regulation (EC) no 1901/2006 of the European parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004
    • Regulation (EC) no 1901/2006 of the European parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union. 2006;L378:1-19.
    • (2006) Official Journal of the European Union , vol.L378 , pp. 1-19
  • 3
    • 0032476883 scopus 로고    scopus 로고
    • Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biologic products in pediatrics patients (21 CFR Parts 201, 312, 314, and 601)
    • Food and Drug Administration (FDA)
    • Food and Drug Administration (FDA). Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biologic products in pediatrics patients (21 CFR Parts 201, 312, 314, and 601). Fed Regist 1998;63.
    • (1998) Fed Regist , pp. 63
  • 4
    • 79956299521 scopus 로고    scopus 로고
    • Networking in paediatrics: The example of the Paediatric Rheumatology International Trials Organisation (PRINTO)
    • Ruperto N, Martini A. Networking in paediatrics: the example of the Paediatric Rheumatology International Trials Organisation (PRINTO). Arch Dis Child 2011;96:596-601.
    • (2011) Arch Dis Child , vol.96 , pp. 596-601
    • Ruperto, N.1    Martini, A.2
  • 6
    • 84861484146 scopus 로고    scopus 로고
    • 16 March 2010 accessed 25 January 2012
    • Report on second workshop of the European Paediatric Research Network (Enpr-EMA), 16 March 2010. http://www.ema.europa.eu/ema/index jsp?curl=pages/news-and-events/events/2010/02/event-detail-000173jsp&murl= menus/news-and-events/news-and- events jsp&mid=WC0b01ac058004d5c3 2010:1-8 (accessed 25 January 2012).
  • 7
    • 84857227050 scopus 로고    scopus 로고
    • A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)
    • Published Online First: 27 November doi:10.1136/archdischild-2011-300286
    • Ruperto N, Eichler I, Herold R, et al. A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA). Arch Dis Child Published Online First: 27 November 2011 doi:10.1136/archdischild-2011-300286.
    • (2011) Arch Dis Child
    • Ruperto, N.1    Eichler, I.2    Herold, R.3
  • 8
    • 79954415278 scopus 로고    scopus 로고
    • Eurofever Project. The Eurofever Project: Towards better care for autoinflammatory diseases
    • Ozen S, Frenkel J, Ruperto N, et al.; Eurofever Project. The Eurofever Project: towards better care for autoinflammatory diseases. Eur J Pediatr 2011;170:445-52.
    • (2011) Eur J Pediatr , vol.170 , pp. 445-452
    • Ozen, S.1    Frenkel, J.2    Ruperto, N.3
  • 9
    • 48349093002 scopus 로고    scopus 로고
    • Abatacept in children with juvenile idiopathic arthritis: A randomised, double-blind, placebo-controlled withdrawal trial
    • Paediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group
    • Ruperto N, Lovell DJ, Quartier P, et al.; Paediatric Rheumatology International Trials Organization; Pediatric Rheumatology Collaborative Study Group. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet 2008;372:383-91.
    • (2008) Lancet , vol.372 , pp. 383-391
    • Ruperto, N.1    Lovell, D.J.2    Quartier, P.3
  • 10
    • 49949115223 scopus 로고    scopus 로고
    • Adalimumab with or without methotrexate in juvenile rheumatoid arthritis
    • Pediatric Rheumatology Collaborative Study Group; Pediatric Rheumatology International Trials Organisation
    • Lovell DJ, Ruperto N, Goodman S, et al.; Pediatric Rheumatology Collaborative Study Group; Pediatric Rheumatology International Trials Organisation. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med 2008;359:810-20.
    • (2008) N Engl J Med , vol.359 , pp. 810-820
    • Lovell, D.J.1    Ruperto, N.2    Goodman, S.3
  • 11
    • 38049075409 scopus 로고    scopus 로고
    • Low risk research using routinely collected identifiable health information without informed consent: Encounters with the Patient Information Advisory Group
    • Metcalfe C, Martin RM, Noble S, et al. Low risk research using routinely collected identifiable health information without informed consent: encounters with the Patient Information Advisory Group. J Med Ethics 2008;34:37-40.
    • (2008) J Med Ethics , vol.34 , pp. 37-40
    • Metcalfe, C.1    Martin, R.M.2    Noble, S.3
  • 12
    • 65349172379 scopus 로고    scopus 로고
    • Feasibility and cost of obtaining informed consent for essential review of medical records in large-scale health services research
    • Noble S, Donovan J, Turner E, et al. Feasibility and cost of obtaining informed consent for essential review of medical records in large-scale health services research. J Health Serv Res Policy 2009;14:77-81.
    • (2009) J Health Serv Res Policy , vol.14 , pp. 77-81
    • Noble, S.1    Donovan, J.2    Turner, E.3
  • 13
    • 77952299939 scopus 로고    scopus 로고
    • Do we need a wider view of autonomy in epidemiological research?
    • Hansson MG. Do we need a wider view of autonomy in epidemiological research? BMJ 2010;340:c.2335,1172-1174.
    • (2010) BMJ , vol.340
    • Hansson, M.G.1
  • 14
    • 79952654904 scopus 로고    scopus 로고
    • Viewpoint: A method to estimate the cost in lives of ethics board review of biomedical research
    • Whitney SN, Schneider CE. Viewpoint: a method to estimate the cost in lives of ethics board review of biomedical research. J Intern Med 2011;269:396-402.
    • (2011) J Intern Med , vol.269 , pp. 396-402
    • Whitney, S.N.1    Schneider, C.E.2
  • 15
    • 79952631742 scopus 로고    scopus 로고
    • Is medical ethics doing its job?
    • Hansson MG, Chadwick R. Is medical ethics doing its job? J Intern Med 2011;269:366-9.
    • (2011) J Intern Med , vol.269 , pp. 366-369
    • Hansson, M.G.1    Chadwick, R.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.