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Volumn 6, Issue 3, 2006, Pages 22-24

How confidential trial negotiations and agreements between the food and drug administration and sponsors marginalize local institutional review boards, and what to do about it

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD SUBSTITUTE; HEMOGLOBIN; POLYMERIZED HEMOGLOBIN;

EID: 33745074908     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265160600685663     Document Type: Note
Times cited : (3)

References (10)
  • 1
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    • Department of Health and Human Services
    • Anon. 2002. Guidance for industry. Special protocol assessment. Department of Health and Human Services. Available at: http://www.webcitation. org/query?id=1138576023249290 (Accessed March 28, 2006).
    • (2002) Guidance for Industry. Special Protocol Assessment
  • 2
    • 33745063387 scopus 로고    scopus 로고
    • An open letter to institutional review boards Considering Northfield Laboratories' PolyHeme® trial
    • Kipnis, K., N. M. P. King, and R. M. Nelson. 2006. An open letter to institutional review boards Considering Northfield Laboratories' PolyHeme® trial. American Journal of Bioethics 6(3):18-21.
    • (2006) American Journal of Bioethics , vol.6 , Issue.3 , pp. 18-21
    • Kipnis, K.1    King, N.M.P.2    Nelson, R.M.3
  • 4
    • 0037010409 scopus 로고    scopus 로고
    • Clinical trial protocols: Agreements between the FDA and industrial sponsors
    • Mann, H. 2002. Clinical trial protocols: Agreements between the FDA and industrial sponsors. Lancet 360(9343): 1345-1346.
    • (2002) Lancet , vol.360 , Issue.9343 , pp. 1345-1346
    • Mann, H.1
  • 5
    • 21344470177 scopus 로고    scopus 로고
    • Equipoise in the enhanced suppression of the platelet IIb/IIIa receptor with integrilin trial (ESPRIT): A critical appraisal
    • Mann, H., A. J. London, and J. Mann. 2005. Equipoise in the enhanced suppression of the platelet IIb/IIIa receptor with integrilin trial (ESPRIT): a critical appraisal. Clinical Trials 2(3): 233-241; discussion 242-243.
    • (2005) Clinical Trials , vol.2 , Issue.3 , pp. 233-241
    • Mann, H.1    London, A.J.2    Mann, J.3
  • 6
    • 84858894191 scopus 로고    scopus 로고
    • Northfield Laboratories. 2005. PolyHeme backgrounder. Available at: http://www.webcitation.org/query?id=1138468571518009 (Accessed March 28, 2006).
    • (2005) PolyHeme Backgrounder
  • 7
    • 0035897706 scopus 로고    scopus 로고
    • Platelet glycoprotein IIb/IIIa receptor blockade with eptifibatide in coronary stent intervention: The ESPRIT trial: A randomized controlled trial
    • O'Shea, J. C., G. E. Hafley, S. Greenberg, V. Hasselblad, T. J. Lorenz, M. M. Kitt, J. Strony, and J. E. Tcheng. 2001. Platelet glycoprotein IIb/IIIa receptor blockade with eptifibatide in coronary stent intervention: the ESPRIT trial: a randomized controlled trial. JAMA 285: 2468-2473.
    • (2001) JAMA , vol.285 , pp. 2468-2473
    • O'Shea, J.C.1    Hafley, G.E.2    Greenberg, S.3    Hasselblad, V.4    Lorenz, T.J.5    Kitt, M.M.6    Strony, J.7    Tcheng, J.E.8
  • 9
    • 6444241859 scopus 로고    scopus 로고
    • Sponsor-Investigator-IRB Interrelationship
    • U.S. Food and Drug Administration. 1998. Guidance for Institutional Review Boards and Clinical Investigators. 1998 Update. Sponsor-Investigator-IRB Interrelationship. Available at: http://www.webcitation.org/query?id= 1138665117132495 (Accessed March 28, 2006).
    • (1998) Guidance for Institutional Review Boards and Clinical Investigators. 1998 Update
  • 10
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    • Regional ethics organizationsfor protection of human research participants
    • Wood, A., C. Grady, and E. Emanuel. 2004. Regional ethics organizationsfor protection of human research participants. Nature Medicine 10(12): 1283-1288.
    • (2004) Nature Medicine , vol.10 , Issue.12 , pp. 1283-1288
    • Wood, A.1    Grady, C.2    Emanuel, E.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.