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Volumn 2, Issue 2, 2008, Pages 151-159

Beyond the therapeutic orphan: Children and clinical trials

Author keywords

Barriers; Children; Ethics; Health; Randomized controlled trials; Recruitment

Indexed keywords

ALTERNATIVE MEDICINE; ARTICLE; BEHAVIOR THERAPY; CANCER RESEARCH; CHILD HEALTH CARE; CHILDHOOD CANCER; CULTURAL SENSITIVITY; DRUG INDUSTRY; DRUG LEGISLATION; EVIDENCE BASED MEDICINE; HUMAN; MEDICAL ETHICS; MEDICAL RESEARCH; PARENTAL ATTITUDE; PATIENT ATTITUDE; PATIENT PARTICIPATION; PATIENT RIGHT; PATIENT SELECTION; PEDIATRIC SURGERY; PEDIATRICIAN; PHYSICIAN ATTITUDE; PSYCHOSOCIAL CARE; RISK BENEFIT ANALYSIS; SOCIAL ASPECT; SURGEON;

EID: 44949254986     PISSN: 17455111     EISSN: None     Source Type: Journal    
DOI: 10.2217/17455111.2.2.151     Document Type: Article
Times cited : (8)

References (47)
  • 1
    • 0015412890 scopus 로고
    • A controlled trial of antepartum glucocorticoid treatment for prevention of respiratory distress syndrome in premature infants
    • Liggins GC, Howie RN: A controlled trial of antepartum glucocorticoid treatment for prevention of respiratory distress syndrome in premature infants. Pediatrics 50, 515-525 (1972).
    • (1972) Pediatrics , vol.50 , pp. 515-525
    • Liggins, G.C.1    Howie, R.N.2
  • 2
    • 35348918800 scopus 로고    scopus 로고
    • Prophylactic corticosteroids for preterm birth
    • Rev. CD000065
    • Crowley P: Prophylactic corticosteroids for preterm birth. Cochrane Database Syst. Rev. CD000065 (2002).
    • (2002) Cochrane Database Syst
    • Crowley, P.1
  • 3
    • 0027103631 scopus 로고
    • Treatment of childhood acute lymphoblastic leukemia: Present issues and future prospects
    • Chessells JM: Treatment of childhood acute lymphoblastic leukemia: present issues and future prospects. Blood Rev. 6, 193-203 (1992).
    • (1992) Blood Rev , vol.6 , pp. 193-203
    • Chessells, J.M.1
  • 4
    • 2542455639 scopus 로고    scopus 로고
    • Survival of children with sickle cell disease
    • Quinn CT, Rogers ZR, Buchanan GT: Survival of children with sickle cell disease. Blood 103, 4023-4027 (2004).
    • (2004) Blood , vol.103 , pp. 4023-4027
    • Quinn, C.T.1    Rogers, Z.R.2    Buchanan, G.T.3
  • 5
    • 0025863475 scopus 로고
    • Prevention of neural tube defects: Results of the Medical Research Council Vitamin Study
    • MRC Vitamin Study Research Group
    • MRC Vitamin Study Research Group. Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. Lancet 338, 131-137 (1991).
    • (1991) Lancet , vol.338 , pp. 131-137
  • 6
    • 2342631856 scopus 로고    scopus 로고
    • Spina bifida and anencephaly before and after folic acid mandate-United States, 1995-1996 and 1999-2000
    • Centers for Disease Control and Prevention CDC
    • Centers for Disease Control and Prevention (CDC). Spina bifida and anencephaly before and after folic acid mandate-United States, 1995-1996 and 1999-2000. MMWR Morb. Mortal. Wkly Rep. 53, 362-365 (2004).
    • (2004) MMWR Morb. Mortal. Wkly Rep , vol.53 , pp. 362-365
  • 8
    • 33845988069 scopus 로고    scopus 로고
    • An absence of pediatric randomized controlled trials in general medical journals
    • Cohen E, Uleryk E, Jasuja M, Parkin PC: An absence of pediatric randomized controlled trials in general medical journals. J. Clin. Epi. 60, 118-23 (2007).
    • (2007) J. Clin. Epi , vol.60 , pp. 118-123
    • Cohen, E.1    Uleryk, E.2    Jasuja, M.3    Parkin, P.C.4
  • 11
    • 0030226625 scopus 로고    scopus 로고
    • Where's the evidence? Putting clinical science into pediatric rheumatology
    • Feldman BM, Giannini EH: Where's the evidence? Putting clinical science into pediatric rheumatology. J. Rheumatol. 23, 1502-1504 (1996).
    • (1996) J. Rheumatol , vol.23 , pp. 1502-1504
    • Feldman, B.M.1    Giannini, E.H.2
  • 12
    • 0037390483 scopus 로고    scopus 로고
    • Randomized controlled trials in pediatric surgery: Could we do better?
    • Curry JI, Reeves B, Stringer MD: Randomized controlled trials in pediatric surgery: could we do better? J. Pediatr. Surg. 38, 556-559 (2003).
    • (2003) J. Pediatr. Surg , vol.38 , pp. 556-559
    • Curry, J.I.1    Reeves, B.2    Stringer, M.D.3
  • 13
    • 0031880145 scopus 로고    scopus 로고
    • A review of randomised controlled trials published in Archives of Disease in Childhood from 1982-1996
    • Campbell H, Surry SA, Royle EM: A review of randomised controlled trials published in Archives of Disease in Childhood from 1982-1996. Arch. Dis. Child. 79, 192-197 (1998).
    • (1998) Arch. Dis. Child , vol.79 , pp. 192-197
    • Campbell, H.1    Surry, S.A.2    Royle, E.M.3
  • 14
    • 24044436574 scopus 로고    scopus 로고
    • A literature review on off-label drug use in children
    • Pandolfini C, Bonati M: A literature review on off-label drug use in children. Eur. J. Pediatr. 164, 552-558 (2005).
    • (2005) Eur. J. Pediatr , vol.164 , pp. 552-558
    • Pandolfini, C.1    Bonati, M.2
  • 15
    • 23344448595 scopus 로고    scopus 로고
    • The treatment of adolescent depression in the era of the black box warning
    • Richmond TK, Rosen DS: The treatment of adolescent depression in the era of the black box warning. Curr. Opin. in Pediatr. 17, 466-472 (2005).
    • (2005) Curr. Opin. in Pediatr , vol.17 , pp. 466-472
    • Richmond, T.K.1    Rosen, D.S.2
  • 16
    • 0014019552 scopus 로고
    • Ethics and clinical Research
    • Beecher H: Ethics and clinical Research, New Engl. J. Med. 274, 1354-1360 (1966).
    • (1966) New Engl. J. Med , vol.274 , pp. 1354-1360
    • Beecher, H.1
  • 17
    • 44949260983 scopus 로고    scopus 로고
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Belmont Report: Ethical Principles and Guideline for the Protection of Human Subjects of Research. Washington DC, USA. US Government Printing Office, DHEW Publication No. (OS) 78-12 (1978).
    • National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Belmont Report: Ethical Principles and Guideline for the Protection of Human Subjects of Research. Washington DC, USA. US Government Printing Office, DHEW Publication No. (OS) 78-12 (1978).
  • 18
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? JAMA 283, 2701-2711 (2000).
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 19
    • 0014244852 scopus 로고
    • Therapeutic orphans
    • Shirkey H: Therapeutic orphans. J. Pediatr. 72, 119-120 (1968).
    • (1968) J. Pediatr , vol.72 , pp. 119-120
    • Shirkey, H.1
  • 21
    • 0642310428 scopus 로고    scopus 로고
    • Dying children and medical research: Access to clinical trials as benefit and burden
    • Oberman M, Frader J: Dying children and medical research: access to clinical trials as benefit and burden. Am. J. Law Med. 29, 301-317 (2003).
    • (2003) Am. J. Law Med , vol.29 , pp. 301-317
    • Oberman, M.1    Frader, J.2
  • 22
    • 27544482107 scopus 로고    scopus 로고
    • A normative justification for distinguishing the ethics of clinical research from the ethics of medical care
    • Litton P, Miller FG: A normative justification for distinguishing the ethics of clinical research from the ethics of medical care. J. Law Med. Ethics 33, 566-574 (2005).
    • (2005) J. Law Med. Ethics , vol.33 , pp. 566-574
    • Litton, P.1    Miller, F.G.2
  • 23
    • 0030229913 scopus 로고    scopus 로고
    • Placebo orthodoxy in clinical research. II: Ethical, legal, and regulatory myths
    • Freedman B, Weijer C, Glass K: Placebo orthodoxy in clinical research. II: Ethical, legal, and regulatory myths. J. Law Med. Ethics 24, 252-259 (1996).
    • (1996) J. Law Med. Ethics , vol.24 , pp. 252-259
    • Freedman, B.1    Weijer, C.2    Glass, K.3
  • 24
    • 0034694856 scopus 로고    scopus 로고
    • ethical principles for medical research involving human subjects
    • World Medical Association Declaration of Helsinki
    • World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 284, 3043-3045 (2000).
    • (2000) JAMA , vol.284 , pp. 3043-3045
  • 25
    • 15844414335 scopus 로고    scopus 로고
    • Potato, potato, proxy consent, permission - just don't call the whole thing off
    • Zlotnik-Shaul R: Potato, potato, proxy consent, permission - just don't call the whole thing off. Critical Care 9, 123-124 (2005).
    • (2005) Critical Care , vol.9 , pp. 123-124
    • Zlotnik-Shaul, R.1
  • 26
    • 38149002118 scopus 로고    scopus 로고
    • Children's and their parents' views on facing research risks for the benefit of others
    • Wendler D, Jenkins T: Children's and their parents' views on facing research risks for the benefit of others. Arch. Pediatr. Adolesc. Med. 162, 9-14 (2008).
    • (2008) Arch. Pediatr. Adolesc. Med , vol.162 , pp. 9-14
    • Wendler, D.1    Jenkins, T.2
  • 27
    • 0035112933 scopus 로고    scopus 로고
    • Participation in research: Informed consent, motivation and influence
    • Hayman RM, Taylor BJ, Peart NS et al.: Participation in research: informed consent, motivation and influence. J. Pediatr. Child. Health. 37, 51-54 (2001).
    • (2001) J. Pediatr. Child. Health , vol.37 , pp. 51-54
    • Hayman, R.M.1    Taylor, B.J.2    Peart, N.S.3
  • 28
    • 33747403867 scopus 로고    scopus 로고
    • Recruiting and retaining Arab Muslim mothers and children for research
    • Aroian K, Katz A, Kulwicki A: Recruiting and retaining Arab Muslim mothers and children for research. J. Nurs. Scholarship 38, 255-261 (2006).
    • (2006) J. Nurs. Scholarship , vol.38 , pp. 255-261
    • Aroian, K.1    Katz, A.2    Kulwicki, A.3
  • 29
    • 34547670991 scopus 로고    scopus 로고
    • Clinical trials: The viewpoint of children
    • Cherrill J, Hudson H, Cocking C et al.: Clinical trials: the viewpoint of children. Arch. Dis. Child. 92, 712-713 (2007).
    • (2007) Arch. Dis. Child , vol.92 , pp. 712-713
    • Cherrill, J.1    Hudson, H.2    Cocking, C.3
  • 30
    • 33646391951 scopus 로고    scopus 로고
    • A questionnaire on factors influencing children's assent and dissent to non-therapeutic research
    • Wolthers OD: A questionnaire on factors influencing children's assent and dissent to non-therapeutic research. J. Med. Ethics 32, 292-297 (2006).
    • (2006) J. Med. Ethics , vol.32 , pp. 292-297
    • Wolthers, O.D.1
  • 31
    • 2642620566 scopus 로고    scopus 로고
    • Offering a randomized trial of intensive therapy for IDDM to adolescents. Reasons for refusal, patient characteristics and recruiter effects
    • Tercyak KPJ, Johnson SB, Kirkpatrick KA, Silverstein JH: Offering a randomized trial of intensive therapy for IDDM to adolescents. Reasons for refusal, patient characteristics and recruiter effects. Diabetes Care 21, 213-215 (1998).
    • (1998) Diabetes Care , vol.21 , pp. 213-215
    • Tercyak, K.P.J.1    Johnson, S.B.2    Kirkpatrick, K.A.3    Silverstein, J.H.4
  • 32
  • 33
    • 35048824745 scopus 로고    scopus 로고
    • Treatment of acute lymphoblastic leukaemia: A new era
    • Apostolidou E, Swords R, Alvarado Y, Giles F: Treatment of acute lymphoblastic leukaemia: a new era. Drugs 67, 2153-2171 (2007).
    • (2007) Drugs , vol.67 , pp. 2153-2171
    • Apostolidou, E.1    Swords, R.2    Alvarado, Y.3    Giles, F.4
  • 34
    • 33747125364 scopus 로고    scopus 로고
    • Trends in survival after childhood cancer in Europe, 1978-1997: Report from the Automated Childhood Cancer Information System project (ACCIS)
    • Magnani C, Pastore G, Coebergh JW et al.: Trends in survival after childhood cancer in Europe, 1978-1997: report from the Automated Childhood Cancer Information System project (ACCIS). Eur. J. Cancer 42, 1981-2005 (2006).
    • (2006) Eur. J. Cancer , vol.42 , pp. 1981-2005
    • Magnani, C.1    Pastore, G.2    Coebergh, J.W.3
  • 35
    • 33748349687 scopus 로고    scopus 로고
    • Little patients, losing patience: Pediatric cancer drug development
    • Boklan J: Little patients, losing patience: pediatric cancer drug development. Mol. Cancer Ther. 5, 1905-1908 (2006).
    • (2006) Mol. Cancer Ther , vol.5 , pp. 1905-1908
    • Boklan, J.1
  • 36
    • 0042195862 scopus 로고    scopus 로고
    • Pediatric drug labelling: Improving the safety and efficacy of pediatric therapies
    • Roberts R, Rodriguez W, Murphy D, Crescenzki T: Pediatric drug labelling: improving the safety and efficacy of pediatric therapies. JAMA 290, 905-911 (2003).
    • (2003) JAMA , vol.290 , pp. 905-911
    • Roberts, R.1    Rodriguez, W.2    Murphy, D.3    Crescenzki, T.4
  • 37
    • 33644655880 scopus 로고    scopus 로고
    • A major new initiative to improve treatment for children
    • Smyth RL, Edwards AD: A major new initiative to improve treatment for children. Arch. Dis. Child. 91, 212-213 (2006).
    • (2006) Arch. Dis. Child , vol.91 , pp. 212-213
    • Smyth, R.L.1    Edwards, A.D.2
  • 39
    • 4644292232 scopus 로고    scopus 로고
    • The transformation of child health in the United States: Social disparities in child health persist despite dramatic improvements in child health overall
    • Wise PH: The transformation of child health in the United States: social disparities in child health persist despite dramatic improvements in child health overall. Health Affairs 23, 9-25 (2004).
    • (2004) Health Affairs , vol.23 , pp. 9-25
    • Wise, P.H.1
  • 40
    • 0035295608 scopus 로고    scopus 로고
    • Complementary and alernative medicine use among children in the Washington DC area
    • Ottoloni MC, Hamburger EK, Loprieato JO et al.: Complementary and alernative medicine use among children in the Washington DC area. Ambul. Pediatr. 1, 122-125 (2001).
    • (2001) Ambul. Pediatr , vol.1 , pp. 122-125
    • Ottoloni, M.C.1    Hamburger, E.K.2    Loprieato, J.O.3
  • 41
    • 0036256309 scopus 로고    scopus 로고
    • Use of complementary/alternative therapies among children in primary care pediatrics
    • Sawni-Sikand A, Schubiner H, Thomas R: Use of complementary/alternative therapies among children in primary care pediatrics. Ambul. Pediatr. 2, 99-103 (2002).
    • (2002) Ambul. Pediatr , vol.2 , pp. 99-103
    • Sawni-Sikand, A.1    Schubiner, H.2    Thomas, R.3
  • 42
    • 33646873514 scopus 로고    scopus 로고
    • Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation
    • Moss RL, Dimmitt RA, Barnhart DC et al.: Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. New Engl. J. Med. 354, 2225-2234 (2006).
    • (2006) New Engl. J. Med , vol.354 , pp. 2225-2234
    • Moss, R.L.1    Dimmitt, R.A.2    Barnhart, D.C.3
  • 43
    • 0031670751 scopus 로고    scopus 로고
    • National Institutes of Health support for research and training: Future of pediatrician scientists
    • McCabe LL: National Institutes of Health support for research and training: future of pediatrician scientists. Arch. Pediatr. Adolesc. Med. 152, 839-842 (1998).
    • (1998) Arch. Pediatr. Adolesc. Med , vol.152 , pp. 839-842
    • McCabe, L.L.1
  • 44
    • 33646926763 scopus 로고    scopus 로고
    • N-of-1 trials: Innovative methods to evaluate complementary and alternative medicines in pediatric cancer
    • Sung L, Feldman BM: N-of-1 trials: innovative methods to evaluate complementary and alternative medicines in pediatric cancer. J. Pediatr. Hematol. Oncol. 28, 263-266 (2006).
    • (2006) J. Pediatr. Hematol. Oncol , vol.28 , pp. 263-266
    • Sung, L.1    Feldman, B.M.2
  • 45
    • 19944425951 scopus 로고    scopus 로고
    • Need for expertise based randomised controlled trials
    • Devereaux PJ, Bhandari M, Clarke M et al.: Need for expertise based randomised controlled trials. Br. Med. J. 330, 88 (2005).
    • (2005) Br. Med. J , vol.330 , pp. 88
    • Devereaux, P.J.1    Bhandari, M.2    Clarke, M.3
  • 46
    • 33847026471 scopus 로고    scopus 로고
    • The role familiarity with science and medicine plays in parents' decision making about enrolling a child in vaccine research
    • Chander TE, Lees A, Moxon ER et al.: The role familiarity with science and medicine plays in parents' decision making about enrolling a child in vaccine research. Qual. Health Res. 17, 311-322 (2007).
    • (2007) Qual. Health Res , vol.17 , pp. 311-322
    • Chander, T.E.1    Lees, A.2    Moxon, E.R.3
  • 47
    • 3042558817 scopus 로고    scopus 로고
    • Committee on Clinical Research Involving Children:, Field MJ, Behrman RE Eds, Institute of Medicine of the National Academies, National Academies Press, Washington, DC, USA
    • Committee on Clinical Research Involving Children: Ethical Conduct of Clinical Research Involving Children. Field MJ, Behrman RE (Eds). Institute of Medicine of the National Academies, National Academies Press, Washington, DC, USA (2004).
    • (2004) Ethical Conduct of Clinical Research Involving Children


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.