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Volumn 130, Issue 2, 2012, Pages 285-292

Pediatric versus adult drug trials for conditions with high pediatric disease burden

Author keywords

Clinical trials; Evidence based medicine; Medication use; Pediatrics; Research subjects

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADOLESCENT; ADULT; ADULTHOOD; ARTICLE; ASTHMA; BIPOLAR DISORDER; CHILD; CHILDHOOD; CHILDHOOD DISEASE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; DEPRESSION; DEVELOPING COUNTRY; DIARRHEA; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; DRUG SCREENING; FUNDING; HEALTH CARE DISPARITY; HEALTH CARE QUALITY; HUMAN; INCOME; INFANT; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALARIA; MIGRAINE; OUTCOME ASSESSMENT; PRESCHOOL CHILD; PRIORITY JOURNAL; PUBLICATION; REGISTRATION; SCHIZOPHRENIA;

EID: 84864497515     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2012-0139     Document Type: Article
Times cited : (109)

References (44)
  • 1
    • 24044436574 scopus 로고    scopus 로고
    • A literature review on off-label drug use in children
    • DOI 10.1007/s00431-005-1698-8
    • Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005;164(9):552-558 (Pubitemid 41225059)
    • (2005) European Journal of Pediatrics , vol.164 , Issue.9 , pp. 552-558
    • Pandolfini, C.1    Bonati, M.2
  • 3
    • 4444351808 scopus 로고    scopus 로고
    • Clinical trials in children
    • DOI 10.1016/S0140-6736(04)16942-0, PII S0140673604169420
    • Caldwell PH, Murphy SB, Butow PN, Craig JC. Clinical trials in children. Lancet. 2004; 364(9436):803-811 (Pubitemid 39165102)
    • (2004) Lancet , vol.364 , Issue.9436 , pp. 803-811
    • Caldwell, P.H.1    Murphy, S.B.2    Butow, P.N.3    Craig, J.C.4
  • 4
    • 0032844199 scopus 로고    scopus 로고
    • Research in children: Ethical and scientific aspects
    • Smyth RL, Weindling AM. Research in children: ethical and scientific aspects. Lancet. 1999;354(suppl 2):SII21-SII24
    • (1999) Lancet , vol.354 , Issue.SUPPL. 2
    • Smyth, R.L.1    Weindling, A.M.2
  • 5
    • 0037206361 scopus 로고    scopus 로고
    • Testing medications in children
    • DOI 10.1056/NEJMhpr021646
    • Steinbrook R. Testing medications in children. N Engl J Med. 2002;347(18):1462-1470 (Pubitemid 35239728)
    • (2002) New England Journal of Medicine , vol.347 , Issue.18 , pp. 1462-1470
    • Steinbrook, R.1
  • 6
    • 79955835951 scopus 로고    scopus 로고
    • Evolution of paediatric off-label use after new significant medicines become available for adults: A study on triptans in Finnish children 1994-2007
    • Lindkvist J, Airaksinen M, Kaukonen AM, Klaukka T, Hoppu K. Evolution of paediatric off-label use after new significant medicines become available for adults: a study on triptans in Finnish children 1994-2007. Br J Clin Pharmacol. 2011;71(6):929-935
    • (2011) Br J Clin Pharmacol , vol.71 , Issue.6 , pp. 929-935
    • Lindkvist, J.1    Airaksinen, M.2    Kaukonen, A.M.3    Klaukka, T.4    Hoppu, K.5
  • 7
    • 34250658338 scopus 로고    scopus 로고
    • Off-label and unlicensed prescribing for children: Have we made any progress?
    • DOI 10.1111/j.1365-2125.2007.02987.x
    • Waller DG. Off-label and unlicensed prescribing for children: have we made any progress? Br J Clin Pharmacol. 2007;64(1): 1-2 (Pubitemid 46934428)
    • (2007) British Journal of Clinical Pharmacology , vol.64 , Issue.1 , pp. 1-2
    • Waller, D.G.1
  • 9
    • 0019562814 scopus 로고
    • Chloramphenicol: A review of its use in clinical practice
    • Feder HM Jr, Osier C, Maderazo EG. Chloramphenicol: a review of its use in clinical practice. Rev Infect Dis. 1981;3(3):479-491
    • (1981) Rev Infect Dis , vol.3 , Issue.3 , pp. 479-491
    • Feder Jr., H.M.1    Osier, C.2    Maderazo, E.G.3
  • 10
    • 0033519054 scopus 로고    scopus 로고
    • Propofol-infusion syndrome in children
    • DOI 10.1016/S0140-6736(99)90018-1
    • Hatch DJ. Propofol-infusion syndrome in children. Lancet. 1999;353(9159):1117-1118 (Pubitemid 29155201)
    • (1999) Lancet , vol.353 , Issue.9159 , pp. 1117-1118
    • Hatch, D.J.1
  • 11
    • 78650382789 scopus 로고    scopus 로고
    • A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007
    • Hamm MP, Hartling L, Milne A, et al. A descriptive analysis of a representative sample of pediatric randomized controlled trials published in 2007. BMC Pediatr. 2010;10:96
    • (2010) BMC Pediatr , vol.10 , pp. 96
    • Hamm, M.P.1    Hartling, L.2    Milne, A.3
  • 12
    • 77950351871 scopus 로고    scopus 로고
    • Child vs adult randomized controlled trials in specialist journals: A citation analysis of trends, 1985-2005
    • Cohen E, Goldman RD, Ragone A, et al. Child vs adult randomized controlled trials in specialist journals: a citation analysis of trends, 1985-2005. Arch Pediatr Adolesc Med. 2010;164(3):283-288
    • (2010) Arch Pediatr Adolesc Med , vol.164 , Issue.3 , pp. 283-288
    • Cohen, E.1    Goldman, R.D.2    Ragone, A.3
  • 13
    • 48249126491 scopus 로고    scopus 로고
    • Child versus adult research: The gap in high-quality study design
    • Martinez-Castaldi C, Silverstein M, Bauchner H. Child versus adult research: the gap in high-quality study design. Pediatrics. 2008; 122(1):52-57
    • (2008) Pediatrics , vol.122 , Issue.1 , pp. 52-57
    • Martinez-Castaldi, C.1    Silverstein, M.2    Bauchner, H.3
  • 14
    • 33845988069 scopus 로고    scopus 로고
    • An absence of pediatric randomized controlled trials in general medical journals, 1985-2004
    • DOI 10.1016/j.jclinepi.2006.03.015, PII S0895435606002885
    • Cohen E, Uleryk E, Jasuja M, Parkin PC. An absence of pediatric randomized controlled trials in general medical journals, 1985-2004. J Clin Epidemiol. 2007;60(2):118-123 (Pubitemid 46039874)
    • (2007) Journal of Clinical Epidemiology , vol.60 , Issue.2 , pp. 118-123
    • Cohen, E.1    Uleryk, E.2    Jasuja, M.3    Parkin, P.C.4
  • 15
    • 77955765928 scopus 로고    scopus 로고
    • A systematic review of safety monitoring and drug toxicity in published randomised controlled trials of antiepileptic drugs in children over a 10-year period
    • Anderson M, Choonara I. A systematic review of safety monitoring and drug toxicity in published randomised controlled trials of antiepileptic drugs in children over a 10-year period. Arch Dis Child. 2010;95(9): 731-738
    • (2010) Arch Dis Child , vol.95 , Issue.9 , pp. 731-738
    • Anderson, M.1    Choonara, I.2
  • 16
    • 77953721442 scopus 로고    scopus 로고
    • A systematic review of paediatric randomised controlled drug trials published in 2007
    • Aripin KN, Choonara I, Sammons HM. A systematic review of paediatric randomised controlled drug trials published in 2007. Arch Dis Child. 2010;95(6):469-473
    • (2010) Arch Dis Child , vol.95 , Issue.6 , pp. 469-473
    • Aripin, K.N.1    Choonara, I.2    Sammons, H.M.3
  • 17
    • 77949481116 scopus 로고    scopus 로고
    • Published pediatric randomized drug trials in developing countries, 1996-2002
    • Nor Aripin KN, Sammons HM, Choonara I. Published pediatric randomized drug trials in developing countries, 1996-2002. Paediatr Drugs. 2010;12(2):99-103
    • (2010) Paediatr Drugs , vol.12 , Issue.2 , pp. 99-103
    • Nor Aripin, K.N.1    Sammons, H.M.2    Choonara, I.3
  • 18
    • 54149090275 scopus 로고    scopus 로고
    • Geneva, Switzerland: World Health Organization; Available at: Accessed May 5, 2012
    • World Health Organization. The global burden of disease: 2004 update. Geneva, Switzerland: World Health Organization; 2008. Available at: www.who.int/evidence/ bod. Accessed May 5, 2012
    • (2008) The Global Burden of Disease: 2004 Update
  • 19
    • 0033578028 scopus 로고    scopus 로고
    • The relation between funding by the National Institutes of Health and the burden of disease
    • DOI 10.1056/NEJM199906173402406
    • Gross CP, Anderson GF, Powe NR. The relation between funding by the National Institutes of Health and the burden of disease. N Engl J Med. 1999;340(24):1881-1887 (Pubitemid 29272669)
    • (1999) New England Journal of Medicine , vol.340 , Issue.24 , pp. 1881-1887
    • Gross, C.P.1    Anderson, G.F.2    Powe, N.R.3
  • 20
    • 0037160930 scopus 로고    scopus 로고
    • Relation between burden of disease and randomised evidence in sub- Saharan Africa: Survey of research
    • Isaakidis P, Swingler GH, Pienaar E, Volmink J, Ioannidis JP. Relation between burden of disease and randomised evidence in sub- Saharan Africa: survey of research. BMJ. 2002;324(7339):702
    • (2002) BMJ , vol.324 , Issue.7339 , pp. 702
    • Isaakidis, P.1    Swingler, G.H.2    Pienaar, E.3    Volmink, J.4    Ioannidis, J.P.5
  • 21
    • 85039722073 scopus 로고    scopus 로고
    • National Institutes of Health. ClinicalTrials. gov. Available at: Accessed May 5, 2012
    • National Institutes of Health. ClinicalTrials. gov. Available at: www.clinicaltrials.gov. Accessed May 5, 2012
  • 22
    • 84857410587 scopus 로고    scopus 로고
    • Lack of head-to-head trials and fair control arms: Randomized controlled trials of biologic treatment for rheumatoid arthritis
    • Estellat C, Ravaud P. Lack of head-to-head trials and fair control arms: randomized controlled trials of biologic treatment for rheumatoid arthritis. Arch Intern Med. 2012; 172(3):237-244
    • (2012) Arch Intern Med , vol.172 , Issue.3 , pp. 237-244
    • Estellat, C.1    Ravaud, P.2
  • 23
    • 79952094973 scopus 로고    scopus 로고
    • The quality of registration of clinical trials
    • Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS ONE. 2011;6 (2):e14701
    • (2011) PLoS ONE , vol.6 , Issue.2
    • Viergever, R.F.1    Ghersi, D.2
  • 24
    • 77955506490 scopus 로고    scopus 로고
    • Outcome reporting among drug trials registered in ClinicalTrials.gov
    • Bourgeois FT, Murthy S, Mandl KD. Outcome reporting among drug trials registered in ClinicalTrials.gov. Ann Intern Med. 2010;153 (3):158-166
    • (2010) Ann Intern Med , vol.153 , Issue.3 , pp. 158-166
    • Bourgeois, F.T.1    Murthy, S.2    Mandl, K.D.3
  • 25
    • 77958555925 scopus 로고    scopus 로고
    • Controlled trials in children: Quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006
    • Thomson D, Hartling L, Cohen E, Vandermeer B, Tjosvold L, Klassen TP. Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006. PLoS ONE. 2010;5(9):e13106
    • (2010) PLoS ONE , vol.5 , Issue.9
    • Thomson, D.1    Hartling, L.2    Cohen, E.3    Vandermeer, B.4    Tjosvold, L.5    Klassen, T.P.6
  • 27
    • 79952267051 scopus 로고    scopus 로고
    • The ClinicalTrials.gov results database - Update and key issues
    • Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database - update and key issues. N Engl J Med. 2011; 364(9):852-860
    • (2011) N Engl J Med , vol.364 , Issue.9 , pp. 852-860
    • Zarin, D.A.1    Tse, T.2    Williams, R.J.3    Califf, R.M.4    Ide, N.C.5
  • 28
    • 54749152234 scopus 로고    scopus 로고
    • Publication of clinical trials supporting successful new drug applications: A literature analysis
    • Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008;5(9):e191
    • (2008) PLoS Med , vol.5 , Issue.9
    • Lee, K.1    Bacchetti, P.2    Sim, I.3
  • 29
    • 0032573850 scopus 로고    scopus 로고
    • Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials
    • Ioannidis JP. Effect of the statistical significance of results on the time to completion and publication of randomized efficacy trials. JAMA. 1998;279(4):281-286
    • (1998) JAMA , vol.279 , Issue.4 , pp. 281-286
    • Ioannidis, J.P.1
  • 33
    • 84874376198 scopus 로고    scopus 로고
    • Pub L No. Best Pharmaceuticals for Children Act of 2007. Title V of Pub L No 110-85. 2007
    • Best Pharmaceuticals for Children Act. Pub L No. Best Pharmaceuticals for Children Act of 2007. Title V of Pub L No 110-85. 2007
    • Best Pharmaceuticals for Children Act
  • 34
    • 33748529495 scopus 로고    scopus 로고
    • Pub L No. Pediatric Research Equity Act of 2007. Title IV of 110-85. 2007
    • Pediatric Research Equity Act. Pub L No. Pediatric Research Equity Act of 2007. Title IV of 110-85. 2007
    • Pediatric Research Equity Act
  • 35
    • 37749021970 scopus 로고    scopus 로고
    • Regulation of drugs for children in Europe
    • Choonara I. Regulation of drugs for children in Europe. BMJ. 2007;335(7632):1221-1222
    • (2007) BMJ , vol.335 , Issue.7632 , pp. 1221-1222
    • Choonara, I.1
  • 36
    • 38449091932 scopus 로고    scopus 로고
    • WHO launches campaign to make drugs safer for children
    • Watts G. WHO launches campaign to make drugs safer for children. BMJ. 2007;335 (7632):1227
    • (2007) BMJ , vol.335 , Issue.7632 , pp. 1227
    • Watts, G.1
  • 37
    • 48849093339 scopus 로고    scopus 로고
    • Ghostwriters, data manipulation and dollar diplomacy: How drug companies pull the strings in clinical research
    • Berger E. Ghostwriters, data manipulation and dollar diplomacy: how drug companies pull the strings in clinical research. Ann Emerg Med. 2008;52(2):137-139
    • (2008) Ann Emerg Med , vol.52 , Issue.2 , pp. 137-139
    • Berger, E.1
  • 39
    • 18744414518 scopus 로고    scopus 로고
    • Clinical trials of medication in children, 1996-2002 [2]
    • DOI 10.1007/s00228-005-0894-9
    • Sammons HM, Choonara I. Clinical trials of medication in children, 1996-2002. Eur J Clin Pharmacol. 2005;61(2):165-167 (Pubitemid 40674751)
    • (2005) European Journal of Clinical Pharmacology , vol.61 , Issue.2 , pp. 165-167
    • Sammons, H.1    Choonara, I.2
  • 40
    • 0033542879 scopus 로고    scopus 로고
    • Drug development output: What proportion for tropical diseases? [9]
    • Trouiller P, Olliaro PL. Drug development output: what proportion for tropical diseases? Lancet. 1999;354(9173):164 (Pubitemid 29313168)
    • (1999) Lancet , vol.354 , Issue.9173 , pp. 164
    • Trouiller, P.1    Olliaro, P.L.2
  • 41
    • 0032580724 scopus 로고    scopus 로고
    • Health research in the tropics
    • DOI 10.1016/S0140-6736(97)10237-9
    • Wolffers I, Adjei S, van der Drift R. Health research in the tropics. Lancet. 1998;351 (9116):1652-1654 (Pubitemid 28252190)
    • (1998) Lancet , vol.351 , Issue.9116 , pp. 1652-1654
    • Wolffers, I.V.1    Adjei, S.2    Van Der, D.R.3
  • 42
    • 56749097839 scopus 로고    scopus 로고
    • Bias, spin, and misreporting: Time for full access to trial protocols and results
    • Chan AW. Bias, spin, and misreporting: time for full access to trial protocols and results. PLoS Med. 2008;5(11):e230
    • (2008) PLoS Med , vol.5 , Issue.11
    • Chan, A.W.1
  • 43
    • 0037164338 scopus 로고    scopus 로고
    • The power of the protocol
    • DOI 10.1016/S0140-6736(02)11652-7
    • Lassere M, Johnson K. The power of the protocol. Lancet. 2002;360(9346):1620-1622 (Pubitemid 35379731)
    • (2002) Lancet , vol.360 , Issue.9346 , pp. 1620-1622
    • Lassere, M.1    Johnson, K.2
  • 44
    • 77955289685 scopus 로고    scopus 로고
    • Comparative effectiveness of medical interventions in adults versus children
    • Contopoulos-Ioannidis DG, Baltogianni MS, Ioannidis JP. Comparative effectiveness of medical interventions in adults versus children. J Pediatr. 2010;157(2):322-330.e17
    • (2010) J Pediatr , vol.157 , Issue.2
    • Contopoulos-Ioannidis, D.G.1    Baltogianni, M.S.2    Ioannidis, J.P.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.