메뉴 건너뛰기




Volumn 126, Issue 3, 2010, Pages

Globalization of pediatric research: Analysis of clinical trials completed for pediatric exclusivity

Author keywords

Clinical trials; Globalization

Indexed keywords

ALLERGY; ARTICLE; CARDIOVASCULAR DISEASE; CENTRAL NERVOUS SYSTEM DISEASE; CHILD; DRUG INDUSTRY; HUMAN; IMMUNOLOGY; INFECTION; MENTAL DISEASE; PEDIATRICS; PRIORITY JOURNAL; BIBLIOMETRICS; CLINICAL TRIAL (TOPIC); INTERNATIONAL COOPERATION; MEDICAL RESEARCH; STATISTICS AND NUMERICAL DATA; TRENDS;

EID: 77956288553     PISSN: 00314005     EISSN: 10984275     Source Type: Journal    
DOI: 10.1542/peds.2010-0098     Document Type: Article
Times cited : (40)

References (21)
  • 2
    • 60849106348 scopus 로고    scopus 로고
    • Ethical and scientific implications of the globalization of clinical research
    • Glickman SW, McHutchinson JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816-823
    • (2009) N Engl J Med , vol.360 , Issue.8 , pp. 816-823
    • Glickman, S.W.1    McHutchinson, J.G.2    Peterson, E.D.3
  • 3
    • 33846878293 scopus 로고    scopus 로고
    • Economic return of clinical trials performed under the Pediatric Exclusivity Program
    • Li JS, Eisenstein EL, Grabowski HG, et al. Economic return of clinical trials performed under the Pediatric Exclusivity Program. JAMA. 2007;297(5):480-488
    • (2007) JAMA , vol.297 , Issue.5 , pp. 480-488
    • Li, J.S.1    Eisenstein, E.L.2    Grabowski, H.G.3
  • 4
    • 77956284172 scopus 로고    scopus 로고
    • Silver Spring, MD: Food and Drug Administration; Available at: Accessed January 5, 2010
    • Food and Drug Administration. Pediatric Exclusivity Provision, January 2001 Status Report to Congress. Silver Spring, MD: Food and Drug Administration; 2001. Available at: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/UCM049915.pdf. Accessed January 5, 2010
    • (2001) Pediatric Exclusivity Provision, January 2001 Status Report to Congress
  • 5
    • 77956294029 scopus 로고    scopus 로고
    • US Congress. Available at: Accessed January 5, 2010
    • US Congress. Best Pharmaceuticals for Children Act. Available at: www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ UCM049874.pdf. Accessed January 5, 2010
    • Best Pharmaceuticals for Children Act
  • 6
    • 72149126826 scopus 로고    scopus 로고
    • Available at: Accessed January 5, 2010
    • Food and Drug Administration. Pediatric exclusivity labeling changes. Available at: www.fda.gov/downloads/ScienceResearch/SpecialTopics/ PediatricTherapeuticsResearch/UCM163159.pdf. Accessed January 5, 2010
    • Pediatric Exclusivity Labeling Changes
  • 7
    • 33748646758 scopus 로고    scopus 로고
    • Peer-reviewed publication of clinical trials completed for pediatric exclusivity
    • Benjamin DK, Smith PB, Murphy MD, et al. Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA. 2006;296(10):1266- 1273
    • (2006) JAMA , vol.296 , Issue.10 , pp. 1266-1273
    • Benjamin, D.K.1    Smith, P.B.2    Murphy, M.D.3
  • 9
    • 60849093851 scopus 로고    scopus 로고
    • 21st annual report: Belt tightens on big pharma
    • Truelove C. 21st annual report: belt tightens on big pharma. Med Ad News. 2007;13(9):4-7
    • (2007) Med Ad News , vol.13 , Issue.9 , pp. 4-7
    • Truelove, C.1
  • 10
    • 17244367345 scopus 로고    scopus 로고
    • A new colonialism? - Conducting clinical trials in India
    • DOI 10.1056/NEJMp048361
    • Nundy S, Gulhati CM. A new colonialism? Conducting clinical trials in India. N Engl J Med. 2005;352(16):1633-1636 (Pubitemid 40530229)
    • (2005) New England Journal of Medicine , vol.352 , Issue.16 , pp. 1633-1636
    • Nundy, S.1    Gulhati, C.M.2
  • 11
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22(2):151-185
    • (2003) J Health Econ , vol.22 , Issue.2 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 12
    • 5644262577 scopus 로고    scopus 로고
    • Randomized clinical trials: Slow death by a thousand unnecessary polices?
    • Yusuf S. Randomized clinical trials: slow death by a thousand unnecessary polices? CMAJ. 2004;171(8):889-892
    • (2004) CMAJ , vol.171 , Issue.8 , pp. 889-892
    • Yusuf, S.1
  • 13
    • 0035433075 scopus 로고    scopus 로고
    • Conducting pediatric cardiovascular trials
    • Sanders SP. Conducting pediatric cardiovascular trials. Am Heart J. 2001;142(2):218-223
    • (2001) Am Heart J , vol.142 , Issue.2 , pp. 218-223
    • Sanders, S.P.1
  • 14
    • 67650324285 scopus 로고    scopus 로고
    • Pediatric assent for a study of antiretroviral therapy dosing for children in western Kenya: A case study in international research collaboration
    • Vreeman RC, Nyandiko WM, Meslin EM. Pediatric assent for a study of antiretroviral therapy dosing for children in western Kenya: a case study in international research collaboration. J Empir Res Hum Res Ethics. 2009;4(1):3-16
    • (2009) J Empir Res Hum Res Ethics , vol.4 , Issue.1 , pp. 3-16
    • Vreeman, R.C.1    Nyandiko, W.M.2    Meslin, E.M.3
  • 15
    • 34447570725 scopus 로고    scopus 로고
    • Globalization of cardiovascular clinical research: The balance between meeting medical needs and maintaining scientific standards
    • Stough WG, Zannad F, Pitt B, Goldstein S. Globalization of cardiovascular clinical research: the balance between meeting medical needs and maintaining scientific standards. Am Heart J. 2007;154(2):232-238
    • (2007) Am Heart J , vol.154 , Issue.2 , pp. 232-238
    • Stough, W.G.1    Zannad, F.2    Pitt, B.3    Goldstein, S.4
  • 17
    • 0036186176 scopus 로고    scopus 로고
    • Ethics in international health research: A perspective from the developing world
    • Bhutta ZA. Ethics in international health research: a perspective from the developing world. Bull World Health Organ. 2002;80(2):114-120 (Pubitemid 34207740)
    • (2002) Bulletin of the World Health Organization , vol.80 , Issue.2 , pp. 114-120
    • Bhutta, Z.A.1
  • 19
    • 0003433351 scopus 로고    scopus 로고
    • Geneva, Switzerland: Council for International Organizations of Medical Sciences; Available at: Accessed January 5, 2010
    • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva, Switzerland: Council for International Organizations of Medical Sciences; 2002. Available at: www.cioms.ch/frame-guidelines-nov-2002. htm. Accessed January 5, 2010
    • (2002) International Ethical Guidelines for Biomedical Research Involving Human Subjects
  • 20
    • 0035849989 scopus 로고    scopus 로고
    • Ethical issues in the design and conduct of clinical trials in developing countries
    • Shapiro HT, Meslin EM. Ethical issues in the design and conduct of clinical trials in developing countries. N Engl J Med. 2001;345(2):139-142
    • (2001) N Engl J Med , vol.345 , Issue.2 , pp. 139-142
    • Shapiro, H.T.1    Meslin, E.M.2
  • 21
    • 1342287922 scopus 로고    scopus 로고
    • Ethical review of health research: A perspective from developing country researchers
    • Hyder AA, Wali SA, Khan AN, Teoh NB, Kass NE, Dawson L. Ethical review of health research: a perspective from developing country researchers. J Med Ethics. 2004;30(1):68-72
    • (2004) J Med Ethics , vol.30 , Issue.1 , pp. 68-72
    • Hyder, A.A.1    Wali, S.A.2    Khan, A.N.3    Teoh, N.B.4    Kass, N.E.5    Dawson, L.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.