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Volumn 5, Issue 3, 2012, Pages 139-146

Ethical challenges in paediatric clinical trials in multiple sclerosis

Author keywords

adolescence; childhood; clinical trials; ethics; immunomodulatory treatment; immunosuppression; multiple sclerosis; new therapies; recruitment

Indexed keywords

ALEMTUZUMAB; DACLIZUMAB; FINGOLIMOD; FUMARIC ACID DIMETHYL ESTER; LAQUINIMOD; OCRELIZUMAB; OFATUMUMAB; PLACEBO; RITUXIMAB; TERIFLUNOMIDE;

EID: 84860808732     PISSN: 17562856     EISSN: 17562864     Source Type: Journal    
DOI: 10.1177/1756285612437360     Document Type: Review
Times cited : (10)

References (34)
  • 1
    • 82955162766 scopus 로고    scopus 로고
    • Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives
    • Altavilla A. Manfredi C. Baiardi P. Dehlinger-Kremer M. Galletti P. Alemany A. et al. (2012) Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives. Acta Paediatr 101: e27–e32.
    • (2012) Acta Paediatr , vol.101 , pp. e27-e32
    • Altavilla, A.1    Manfredi, C.2    Baiardi, P.3    Dehlinger-Kremer, M.4    Galletti, P.5    Alemany, A.6
  • 2
    • 79751527551 scopus 로고    scopus 로고
    • Therapies for multiple sclerosis: considerations in the pediatric patient
    • Banwell B. Bar-Or A. Giovannoni G. Dale R.C. Tardieu M. (2011) Therapies for multiple sclerosis: considerations in the pediatric patient. Nat Rev Neurol 7: 109–122.
    • (2011) Nat Rev Neurol , vol.7 , pp. 109-122
    • Banwell, B.1    Bar-Or, A.2    Giovannoni, G.3    Dale, R.C.4    Tardieu, M.5
  • 4
    • 0037044285 scopus 로고    scopus 로고
    • University of British Columbia MS Clinic Neurologists
    • Early onset multiple sclerosis: a longitudinal study
    • Boiko A. Vorobeychik G. Paty D. Devonshire V. Sadovnick D. ; University of British Columbia MS Clinic Neurologists. (2002) Early onset multiple sclerosis: a longitudinal study. Neurology 59: 1006–1010.
    • (2002) Neurology , vol.59 , pp. 1006-1010
    • Boiko, A.1    Vorobeychik, G.2    Paty, D.3    Devonshire, V.4    Sadovnick, D.5
  • 5
    • 65349094587 scopus 로고    scopus 로고
    • Demographics of pediatric-onset multiple sclerosis in an MS center population from the Northeastern United States
    • Chitnis T. Glanz B. Jaffin S. Healy B. (2009) Demographics of pediatric-onset multiple sclerosis in an MS center population from the Northeastern United States. Mult Scler 15: 627–631.
    • (2009) Mult Scler , vol.15 , pp. 627-631
    • Chitnis, T.1    Glanz, B.2    Jaffin, S.3    Healy, B.4
  • 6
    • 84855965204 scopus 로고    scopus 로고
    • for the International Pediatric Multiple Sclerosis Study Group
    • Consensus statement: evaluation of new and existing therapeutics for pediatric multiple sclerosis
    • Chitnis T. Tenembaum S. Banwell B. Krupp L. Pohl D. Rostasy K. et al.; for the International Pediatric Multiple Sclerosis Study Group. (2012) Consensus statement: evaluation of new and existing therapeutics for pediatric multiple sclerosis. Mult Scler 18: 116–127.
    • (2012) Mult Scler , vol.18 , pp. 116-127
    • Chitnis, T.1    Tenembaum, S.2    Banwell, B.3    Krupp, L.4    Pohl, D.5    Rostasy, K.6
  • 7
    • 79955455801 scopus 로고    scopus 로고
    • Mechanisms of fingolimod”s efficacy and adverse effects in multiple sclerosis
    • Cohen J.A. Chun J. (2011) Mechanisms of fingolimod”s efficacy and adverse effects in multiple sclerosis. Ann Neurol 69: 759–777.
    • (2011) Ann Neurol , vol.69 , pp. 759-777
    • Cohen, J.A.1    Chun, J.2
  • 9
    • 80053207130 scopus 로고    scopus 로고
    • Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort
    • Cossburn M. Pace A.A. Jones J. Ali R. Ingram G. Baker K. (2011) Autoimmune disease after alemtuzumab treatment for multiple sclerosis in a multicenter cohort. Neurology 77: 573–579.
    • (2011) Neurology , vol.77 , pp. 573-579
    • Cossburn, M.1    Pace, A.A.2    Jones, J.3    Ali, R.4    Ingram, G.5    Baker, K.6
  • 11
    • 53549108038 scopus 로고    scopus 로고
    • Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
    • European Union
    • European Union. (2008) Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Eur J Health Law 15: 223–250.
    • (2008) Eur J Health Law , vol.15 , pp. 223-250
  • 13
    • 77954912129 scopus 로고    scopus 로고
    • Therapeutic strategies in childhood multiple sclerosis
    • Ghezzi A. (2010) Therapeutic strategies in childhood multiple sclerosis. Ther Adv Neurol Disord 3: 217–228.
    • (2010) Ther Adv Neurol Disord , vol.3 , pp. 217-228
    • Ghezzi, A.1
  • 14
    • 67349159369 scopus 로고    scopus 로고
    • Long-term results of immunomodulatory treatment in children and adolescents with multiple sclerosis: the Italian experience
    • Ghezzi A. Amato M.P. Annovazzi P. Capobianco M. Gallo P. La Mantia L. et al. (2009) Long-term results of immunomodulatory treatment in children and adolescents with multiple sclerosis: the Italian experience. Neurol Sci 30: 193–199.
    • (2009) Neurol Sci , vol.30 , pp. 193-199
    • Ghezzi, A.1    Amato, M.P.2    Annovazzi, P.3    Capobianco, M.4    Gallo, P.5    La Mantia, L.6
  • 16
    • 1242284429 scopus 로고    scopus 로고
    • 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. (2004) 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). Eur J Pediatr 163: 53–57.
    • (2004) Eur J Pediatr , vol.163 , pp. 53-57
    • Gill, D.1
  • 17
  • 18
    • 77955641535 scopus 로고    scopus 로고
    • Randomized clinical trials in children – ethical and methodological issues
    • Henschel A.D. Rothenberger L.G. Boos J. (2010) Randomized clinical trials in children – ethical and methodological issues. Curr Pharm Des 16: 2407–2415.
    • (2010) Curr Pharm Des , vol.16 , pp. 2407-2415
    • Henschel, A.D.1    Rothenberger, L.G.2    Boos, J.3
  • 19
    • 81555202418 scopus 로고    scopus 로고
    • Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial
    • Kappos L. Li D. Calabresi P.A. O'Connor P. Bar-Or A. Barkhof F. et al. (2011) Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial. Lancet 378: 1779–1787.
    • (2011) Lancet , vol.378 , pp. 1779-1787
    • Kappos, L.1    Li, D.2    Calabresi, P.A.3    O'Connor, P.4    Bar-Or, A.5    Barkhof, F.6
  • 20
    • 79956024142 scopus 로고    scopus 로고
    • Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomized extension of the TRANSFORMS study
    • Khatri B. Barkhof F. Comi G. Hartung H.P. Kappos L. Montalban X. et al. (2011) Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomized extension of the TRANSFORMS study. Lancet Neurol 10: 520–529.
    • (2011) Lancet Neurol , vol.10 , pp. 520-529
    • Khatri, B.1    Barkhof, F.2    Comi, G.3    Hartung, H.P.4    Kappos, L.5    Montalban, X.6
  • 22
    • 73949159847 scopus 로고    scopus 로고
    • Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies
    • Klein N.P. Ray P. Carpenter D. Hansen J. Lewis E. Fireman B. et al. (2010) Rates of autoimmune diseases in Kaiser Permanente for use in vaccine adverse event safety studies. Vaccine 28: 1062–1068.
    • (2010) Vaccine , vol.28 , pp. 1062-1068
    • Klein, N.P.1    Ray, P.2    Carpenter, D.3    Hansen, J.4    Lewis, E.5    Fireman, B.6
  • 25
    • 77953335494 scopus 로고    scopus 로고
    • Rituximab add-on therapy for breakthrough relapsing multiple sclerosis. A 52-week phase II trial
    • Naismith R.T. Piccio L. Lyons J.A. Lauber J. Tutlam N.T. Parks B.J. et al. (2010) Rituximab add-on therapy for breakthrough relapsing multiple sclerosis. A 52-week phase II trial. Neurology 74: 1860–1867.
    • (2010) Neurology , vol.74 , pp. 1860-1867
    • Naismith, R.T.1    Piccio, L.2    Lyons, J.A.3    Lauber, J.4    Tutlam, N.T.5    Parks, B.J.6
  • 26
    • 41549132629 scopus 로고    scopus 로고
    • Ethics of placebo-controlled clinical trials in multiple sclerosis. A reassessment
    • Polman C.H. Reingold S.C. Barkhof F. Calabresi P.A. Clanet M. Cohen J.A. et al. (2008) Ethics of placebo-controlled clinical trials in multiple sclerosis. A reassessment. Neurology 70: 1134–1140.
    • (2008) Neurology , vol.70 , pp. 1134-1140
    • Polman, C.H.1    Reingold, S.C.2    Barkhof, F.3    Calabresi, P.A.4    Clanet, M.5    Cohen, J.A.6
  • 27
    • 84860832321 scopus 로고    scopus 로고
    • Ethics of placebo-controlled clinical trials in multiple sclerosis. Appendix e-3. Example of sample size calculation for placebo versus active-arm comparator trials
    • Polman C.H. Reingold S.C. Barkhof F. Calabresi P.A. Clanet M. Cohen J.A. et al. (2008) Ethics of placebo-controlled clinical trials in multiple sclerosis. Appendix e-3. Example of sample size calculation for placebo versus active-arm comparator trials. Neurology 70: 1–2.
    • (2008) Neurology , vol.70 , pp. 1-2
    • Polman, C.H.1    Reingold, S.C.2    Barkhof, F.3    Calabresi, P.A.4    Clanet, M.5    Cohen, J.A.6
  • 29
    • 84860390375 scopus 로고    scopus 로고
    • Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naïve, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial
    • Taylor P.C. Quattrocchi E. Mallett S. Kurrasch R. Petersen J. Chang D.J. (2011) Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naïve, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial. Ann Rheum Dis 70: 2119–2125.
    • (2011) Ann Rheum Dis , vol.70 , pp. 2119-2125
    • Taylor, P.C.1    Quattrocchi, E.2    Mallett, S.3    Kurrasch, R.4    Petersen, J.5    Chang, D.J.6
  • 30
    • 77955662419 scopus 로고    scopus 로고
    • Therapy of multiple sclerosis in children and adolescents
    • Tenembaum S.N. (2010) Therapy of multiple sclerosis in children and adolescents. Clin Neurol Neurosurg 112: 633–640.
    • (2010) Clin Neurol Neurosurg , vol.112 , pp. 633-640
    • Tenembaum, S.N.1
  • 31
    • 84993730943 scopus 로고
    • US Department of Health, Education, and Welfare. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
    • US Department of Health, Education, and Welfare. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. http://ohsr.od.nih.gov/guidelines/belmont.html
    • (1979) The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research
  • 33
    • 77949301468 scopus 로고    scopus 로고
    • Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta
    • Wynn D. Kaufman M. Montalban X. Vollmer T. Simon J. Elkins J. et al. (2010) Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol 9: 381–390.
    • (2010) Lancet Neurol , vol.9 , pp. 381-390
    • Wynn, D.1    Kaufman, M.2    Montalban, X.3    Vollmer, T.4    Simon, J.5    Elkins, J.6
  • 34
    • 79953848705 scopus 로고    scopus 로고
    • Multiple sclerosis therapy in pediatric patients with refractory multiple sclerosis
    • Yeh E.A. Waubant E. Krupp L.B. Ness J. Chitnis T. Kuntz N. et al. (2011) Multiple sclerosis therapy in pediatric patients with refractory multiple sclerosis. Arch Neurol 68: 437–444.
    • (2011) Arch Neurol , vol.68 , pp. 437-444
    • Yeh, E.A.1    Waubant, E.2    Krupp, L.B.3    Ness, J.4    Chitnis, T.5    Kuntz, N.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.