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Volumn 37, Issue 1, 2011, Pages

Framework conditions facilitating paediatric clinical research

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO;

EID: 79960950924     PISSN: 17208424     EISSN: 18247288     Source Type: Journal    
DOI: 10.1186/1824-7288-37-12     Document Type: Review
Times cited : (15)

References (43)
  • 3
    • 78049393729 scopus 로고    scopus 로고
    • The European paediatric legislation: Benefits and perspectives
    • The European paediatric legislation: benefits and perspectives. Rocchi F, Paolucci P, Ceci A, Rossi P, Italian J Pediatr 2010 36 56
    • (2010) Italian J Pediatr , vol.36 , pp. 56
    • Rocchi, F.1    Paolucci, P.2    Ceci, A.3    Rossi, P.4
  • 4
    • 34548502723 scopus 로고    scopus 로고
    • The EU's new paediatric medicines legislation: Serving children's needs?
    • DOI 10.1136/adc.2006.105692
    • The EU's new paediatric medicines legislation: serving children's needs? Permanand G, Mossialos E, McKee M, Arch Dis Child 2007 92 808 811 (Pubitemid 47372537)
    • (2007) Archives of Disease in Childhood , vol.92 , Issue.9 , pp. 808-811
    • Permanand, G.1    Mossialos, E.2    McKee, M.3
  • 5
    • 34748850652 scopus 로고    scopus 로고
    • Consequences of Directive 2001/20/EC for investigator-initiated trials in the paediatric population - A field report
    • DOI 10.1007/s00431-007-0434-y
    • Consequences of Directives 2001/20/EC for investigator-initiated trials in the paediatric population-a filed report. Welzing L, Harnischmacher U, Weyersberg A, Roth B, Eur J Pediatr 2007 166 1169 1176 (Pubitemid 47476632)
    • (2007) European Journal of Pediatrics , vol.166 , Issue.11 , pp. 1169-1176
    • Welzing, L.1    Harnischmacher, U.2    Weyersberg, A.3    Roth, B.4
  • 6
    • 77955765928 scopus 로고    scopus 로고
    • A systematic review of safety and monitoring and drug toxicity in published controlled trials antiepileptic drugs in children over a 10 year period
    • A systematic review of safety and monitoring and drug toxicity in published controlled trials antiepileptic drugs in children over a 10 year period. Anderson M, Choonara I, Arch Dis Child 2010 95 731 738
    • (2010) Arch Dis Child , vol.95 , pp. 731-738
    • Anderson, M.1    Choonara, I.2
  • 10
    • 0347627457 scopus 로고    scopus 로고
    • Paediatric clinical trials: Redressing the imbalance
    • Paediatric Clinical trials: redressing the imbalance. Schreiner MS, Nat Rev Drug Discov 2003 2 949 961 (Pubitemid 37540577)
    • (2003) Nature Reviews Drug Discovery , vol.2 , Issue.12 , pp. 949-961
    • Schreiner, M.S.1
  • 11
    • 33947355479 scopus 로고    scopus 로고
    • Future of pediatric therapeutics: Reauthorization of BPCA and PREA
    • DOI 10.1038/sj.clpt.6100109, PII 6100109
    • Future of Pediatric Therapeutics: Reauthorization of BPCA and PREA. Ward RM, Kauffman R, Clin Pharmacol Ther 2007 81 477 479 (Pubitemid 46452311)
    • (2007) Clinical Pharmacology and Therapeutics , vol.81 , Issue.4 , pp. 477-479
    • Ward, R.M.1    Kauffman, R.2
  • 15
    • 33750000866 scopus 로고    scopus 로고
    • Legal Interpretation at the European Court of Justice
    • Legal Interpretation At The European Court Of Justice. Fennelly N, 20 Fordham Int'l L.J. 656 1997
    • (1997) 20 Fordham Int'l L.J. 656
    • Fennelly, N.1
  • 17
    • 0038696447 scopus 로고    scopus 로고
    • Parents' attitudes to children's participation in randomized controlled trials
    • DOI 10.1067/mpd.2003.192
    • Parents' attitudes to children's participation in randomized controlled trials. Caldwell PHY, Butow PN, Craig JC, J Pediatr 2003 142 554 559 (Pubitemid 36623567)
    • (2003) Journal of Pediatrics , vol.142 , Issue.5 , pp. 554-559
    • Caldwell, P.H.Y.1    Butow, P.N.2    Craig, J.C.3
  • 18
    • 2542462183 scopus 로고    scopus 로고
    • From informed consent to shared consent: A developing process in paediatric oncology
    • DOI 10.1016/S1470-2045(04)01496-2, PII S1470204504014962
    • From informed consent to shared consent: a developing process in paediatric oncology. Massimo LM, Wiley TJ, Casari EF, Lancet Oncol 2004 5 384 387 (Pubitemid 38684411)
    • (2004) Lancet Oncology , vol.5 , Issue.6 , pp. 384-387
    • Massimo, L.1    Wiley, T.J.2    Casari, E.F.3
  • 19
    • 0036916573 scopus 로고    scopus 로고
    • Pediatricians' attitudes toward randomized controlled trials involving children
    • DOI 10.1067/mpd.2002.129173
    • Pediatricians' attitudes toward randomized controlled trials involving children. Caldwell PHY, Butow PN, Craig JC, J Pediatr 2002 141 798 803 (Pubitemid 35471641)
    • (2002) Journal of Pediatrics , vol.141 , Issue.6 , pp. 798-803
    • Caldwell, P.H.Y.1    Butow, P.N.2    Craig, J.C.3
  • 20
    • 0034021319 scopus 로고    scopus 로고
    • Guidelines for the ethical conduct of medical research involving children
    • DOI 10.1136/adc.82.2.177
    • Guidelines for the ethical conduct of medical research involving children. Royal College of Paediatrics and Child Health: Ethics Advisory Committee. McIntosh N, Bates P, Brykczynska G, Dunstan G, Goldman A, Harvey D, Larcher V, McCrae D, McKinnon A, Patton M, Saunders J, Shelley P, Arch Dis Child 2000 82 177 182 (Pubitemid 30305718)
    • (2000) Archives of Disease in Childhood , vol.82 , Issue.2 , pp. 177-182
    • McIntosh, N.1
  • 21
    • 66749099694 scopus 로고    scopus 로고
    • Ethical issues of clinical trials in children: A European perspective
    • Ethical issues of clinical trials in children: a European perspective. Sammons H, Arch Dis Child 2009 94 474 477
    • (2009) Arch Dis Child , vol.94 , pp. 474-477
    • Sammons, H.1
  • 24
    • 0037329077 scopus 로고    scopus 로고
    • Informed consent for pediatric research: Is it really possible?
    • DOI 10.1067/mpd.2003.64
    • Informed consent for pediatric research: is it really possible? Kodish E, J Pediatr 2003 142 89 90 (Pubitemid 36232889)
    • (2003) Journal of Pediatrics , vol.142 , Issue.2 , pp. 89-90
    • Kodish, E.1
  • 25
    • 53549131496 scopus 로고    scopus 로고
    • European survey on the ethical and legal frameworks of clinical trials in paediatrics; Results and perpectives
    • 121-122
    • European survey on the ethical and legal frameworks of clinical trials in paediatrics; results and perpectives. Altavilla A, Giaquinto C, Ceci A, J Int Bioéthique 2008 19 17 48 121-122
    • (2008) J Int Bioéthique , vol.19 , pp. 17-48
    • Altavilla, A.1    Giaquinto, C.2    Ceci, A.3
  • 27
    • 33645779088 scopus 로고    scopus 로고
    • Assent in paediatric research: Theoretical and practical considerations
    • Assent in paediatric research: theoretical and practical considerations. Wendler DS, J Med Ethics 2006 32 229 234
    • (2006) J Med Ethics , vol.32 , pp. 229-234
    • Wendler, D.S.1
  • 28
    • 1242284429 scopus 로고    scopus 로고
    • Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP)
    • DOI 10.1007/s00431-003-1378-5
    • Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the ethics working group of Confederation of European Specialists in Paediatrics (CESP). Gill D, Eur J Pediatr 2004 163 53 57 (Pubitemid 38223385)
    • (2004) European Journal of Pediatrics , vol.163 , Issue.2 , pp. 53-57
    • Gill, D.1
  • 30
    • 38149002118 scopus 로고    scopus 로고
    • Children's and their parents' views on facing research risks for the benefit of others
    • Children's and their parents' views on facing research risks for the benefit of others. Wendler D, Jenkins T, Arch Pediatr Adolesc Med 2008 162 9 14
    • (2008) Arch Pediatr Adolesc Med , vol.162 , pp. 9-14
    • Wendler, D.1    Jenkins, T.2
  • 34
    • 36549027866 scopus 로고    scopus 로고
    • Adaptation of the application of Good Clinical Practice depending on the features of research projects
    • Adaptation of the application of Good Clinical Practice depending on the features of research projects. Bertoye PH, Courcier-Duplantier S, Best N, the participants in Round Table N°2, Giens XXI, Therapie 2006 61 279 285
    • (2006) Therapie , vol.61 , pp. 279-285
    • Bertoye, P.H.1    Courcier-Duplantier, S.2    Best, N.3
  • 36
    • 0028950350 scopus 로고
    • Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations
    • Committee on Drugs American Academy on Pediatrics
    • Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Committee on Drugs, American Academy on Pediatrics, Pediatrics 1995 95 286 294
    • (1995) Pediatrics , vol.95 , pp. 286-294
  • 39
    • 2142658873 scopus 로고    scopus 로고
    • The future of institutional review boards
    • DOI 10.1016/S1470-2045(04)01473-1, PII S1470204504014731
    • The future of institutional review boards. Ghersi D, Campbell EG, Pentz R, Cox Macpherson C, Lancet Oncol 2004 5 325 329 (Pubitemid 38541587)
    • (2004) Lancet Oncology , vol.5 , Issue.5 , pp. 325-329
    • Ghersi, D.1    Campbell, E.G.2    Pentz, R.3    Macpherson, C.C.4
  • 40
    • 39149118018 scopus 로고    scopus 로고
    • Paediatric clinical pharmacology at the beginning of a new era
    • Paediatric clinical pharmacology at the beginning of a new era. Hoppu K, Eur J Clin Pharmacol 2008 64 201 205
    • (2008) Eur J Clin Pharmacol , vol.64 , pp. 201-205
    • Hoppu, K.1
  • 41
    • 85008266376 scopus 로고    scopus 로고
    • Are research ethics committees behaving unethically? Committees are now being expected to do everything
    • Are research ethics committees behaving unethically? Committees are now being expected to do everything. Pierce E, BMJ 1997 314 676
    • (1997) BMJ , vol.314 , pp. 676
    • Pierce, E.1
  • 42
    • 0034728855 scopus 로고    scopus 로고
    • Multicentre research ethics committees: Has the cure been worse than the disease?
    • Multicentre research ethics committees: has the cure been worse than the disease? Alberti K, BMJ 2000 320 1157 1158 (Pubitemid 30224260)
    • (2000) British Medical Journal , vol.320 , Issue.7243 , pp. 1157-1158
    • Alberti, K.G.M.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.