메뉴 건너뛰기




Volumn 8, Issue 5, 2006, Pages 384-389

Assessing and communicating the risks and benefits of gene transfer clinical trials

Author keywords

Clinical trials; Gene transfer; Informed consent; Risk:benefit ratio; Therapeutic misconception

Indexed keywords

ADENOSINE DEAMINASE; ORNITHINE CARBAMOYLTRANSFERASE;

EID: 33750025076     PISSN: 14648431     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (9)

References (38)
  • 1
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? J Am Med Assoc (2000) 283(20):2701-2711.
    • (2000) J Am Med Assoc , vol.283 , Issue.20 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 2
    • 11844303500 scopus 로고    scopus 로고
    • Recent developments in gene transfer: Risk and ethics
    • Kimmelman J: Recent developments in gene transfer: Risk and ethics. Br Med J (2005) 330(7482):79-82.
    • (2005) Br Med J , vol.330 , Issue.7482 , pp. 79-82
    • Kimmelman, J.1
  • 4
    • 11144335939 scopus 로고    scopus 로고
    • Gene transfer for neurologic disease: Agencies, policies, and process
    • Mendell JR, Miller A: Gene transfer for neurologic disease: Agencies, policies, and process. Neurology (2004) 63(12):2225-2232.
    • (2004) Neurology , vol.63 , Issue.12 , pp. 2225-2232
    • Mendell, J.R.1    Miller, A.2
  • 5
    • 8844266041 scopus 로고    scopus 로고
    • Gene therapy progress and prospects: Bringing gene therapy into medical practice: The evolution of International ethics and the regulatory environment
    • Spink J, Geddes D: Gene therapy progress and prospects: Bringing gene therapy into medical practice: The evolution of International ethics and the regulatory environment. Gene Ther (2004) 11(22):1611-1616.
    • (2004) Gene Ther , vol.11 , Issue.22 , pp. 1611-1616
    • Spink, J.1    Geddes, D.2
  • 6
    • 33645953638 scopus 로고    scopus 로고
    • Clinical trial design issues raised during recombinant DNA advisory committee review of gene transfer protocols
    • Scharschmidt T, Lo B: Clinical trial design issues raised during recombinant DNA advisory committee review of gene transfer protocols. Hum Gene Ther (2006) 17(4):448-454.
    • (2006) Hum Gene Ther , vol.17 , Issue.4 , pp. 448-454
    • Scharschmidt, T.1    Lo, B.2
  • 7
    • 0036730970 scopus 로고    scopus 로고
    • RAC oversight of gene transfer research: A model worth extending?
    • King NMP: RAC oversight of gene transfer research: A model worth extending? J Law Med Ethics (2002) 30(3):381-389.
    • (2002) J Law Med Ethics , vol.30 , Issue.3 , pp. 381-389
    • King, N.M.P.1
  • 8
    • 25144455398 scopus 로고    scopus 로고
    • Stakeholders' conference sharpens focus on challenges of clinical gene transfer
    • High KA: Stakeholders' conference sharpens focus on challenges of clinical gene transfer. Mol Ther (2005) 12(4):581-582.
    • (2005) Mol Ther , vol.12 , Issue.4 , pp. 581-582
    • High, K.A.1
  • 9
    • 33645519428 scopus 로고    scopus 로고
    • An emerging consensus on recommendations to facilitate clinical gene transfer
    • Williams DA: An emerging consensus on recommendations to facilitate clinical gene transfer. Mol Ther (2006) 13(4):637-638.
    • (2006) Mol Ther , vol.13 , Issue.4 , pp. 637-638
    • Williams, D.A.1
  • 14
    • 20544452088 scopus 로고    scopus 로고
    • Retroviral vectors: A double-edged sword
    • American Society of Gene Therapy meeting
    • Kaiser J: American Society of Gene Therapy meeting. Retroviral vectors: A double-edged sword. Science (2005) 308(5729):1735-1736.
    • (2005) Science , vol.308 , Issue.5729 , pp. 1735-1736
    • Kaiser, J.1
  • 15
    • 33748359678 scopus 로고    scopus 로고
    • Questions linger about unexplained gene-therapy trial death
    • Abbott A: Questions linger about unexplained gene-therapy trial death. Nat Med (2006) 12(6):567.
    • (2006) Nat Med , vol.12 , Issue.6 , pp. 567
    • Abbott, A.1
  • 17
    • 0142089747 scopus 로고    scopus 로고
    • Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer
    • Raper SE, Chirmule N, Lee FS, Wivel NA, Bagg A, Gao GP, Wison JM, Batshaw ML: Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer. Mol Genet Metab (2003) 80(1-2):148-158.
    • (2003) Mol Genet Metab , vol.80 , Issue.1-2 , pp. 148-158
    • Raper, S.E.1    Chirmule, N.2    Lee, F.S.3    Wivel, N.A.4    Bagg, A.5    Gao, G.P.6    Wison, J.M.7    Batshaw, M.L.8
  • 19
    • 33750012440 scopus 로고    scopus 로고
    • Conclusions and recommendations of the NIH Recombinant DNA Advisory Committee Gene Transfer Safety symposium: Current perspectives on gene transfer for
    • Recombinant DNA Advisory Committee X-SCID In: RAC, National Institutes of Health, Rockville, MD, USA
    • Recombinant DNA Advisory Committee: Conclusions and recommendations of the NIH Recombinant DNA Advisory Committee Gene Transfer Safety symposium: Current perspectives on gene transfer for X-SCID. In: Minutes of the Recombinant DNA Advisory Committee. RAC, National Institutes of Health, Rockville, MD, USA (2005):3-4. http://www4. od.nih.gov/oba/rac/ minutes/RAC_minutes_06-05.pdf
    • (2005) Minutes of the Recombinant DNA Advisory Committee , pp. 3-4
  • 20
    • 33645728427 scopus 로고    scopus 로고
    • Inserting optimism into gene therapy
    • Naldini L: Inserting optimism into gene therapy. Nat Med (2006) 12(4):386-388.
    • (2006) Nat Med , vol.12 , Issue.4 , pp. 386-388
    • Naldini, L.1
  • 21
    • 33749987355 scopus 로고    scopus 로고
    • Office for Human Research Protections: OHRP determination letter to University of Pennsylvania. National Institutes of Health, Rockville, MD, USA May 17
    • Borror KC, Office for Human Research Protections: OHRP determination letter to University of Pennsylvania. National Institutes of Health, Rockville, MD, USA (2001): May 17. http://www.hhs.gov/ohrp/ detrm_letrs/may01a.pdf
    • (2001)
    • Borror, K.C.1
  • 22
    • 33750010469 scopus 로고    scopus 로고
    • US settles case of gone therapy study that ended with teen's death
    • US settles case of gone therapy study that ended with teen's death. University of Pennsylvania Almanac (2005) 51:4-5.
    • (2005) University of Pennsylvania Almanac , vol.51 , pp. 4-5
  • 23
    • 70349923364 scopus 로고    scopus 로고
    • Gene therapy clinical trials worldwide
    • J Gene Med John Wiley and Sons Ltd, London, UK
    • Gene therapy clinical trials worldwide. J Gene Med John Wiley and Sons Ltd, London, UK (2006). http://www.wiley.co.uk/genmed/clinical
    • (2006)
  • 24
    • 4444370799 scopus 로고    scopus 로고
    • Gene therapy clinical trials worldwide 1989-2004 - An overview
    • Edelstein ML, Abedi MR, Wixon J, Edelstein RM: Gene therapy clinical trials worldwide 1989-2004 - an overview. J Gene Med (2004) 6(6):597-602.
    • (2004) J Gene Med , vol.6 , Issue.6 , pp. 597-602
    • Edelstein, M.L.1    Abedi, M.R.2    Wixon, J.3    Edelstein, R.M.4
  • 25
    • 0036622757 scopus 로고    scopus 로고
    • Status and potential of gene therapy in clinical medicine
    • Lyngstadaas A: Status and potential of gene therapy in clinical medicine. Int J Tech Assess Health Care (2002) 18(3):645-674.
    • (2002) Int J Tech Assess Health Care , vol.18 , Issue.3 , pp. 645-674
    • Lyngstadaas, A.1
  • 27
    • 2342464377 scopus 로고    scopus 로고
    • Therapeutic misconception in clinical research: Frequency and risk factors
    • Appelbaum PS, Lidz CW, Grisso T: Therapeutic misconception in clinical research: Frequency and risk factors. IRB Ethics & Human Research (2004) 26(2): 1-8.
    • (2004) IRB Ethics & Human Research , vol.26 , Issue.2 , pp. 1-8
    • Appelbaum, P.S.1    Lidz, C.W.2    Grisso, T.3
  • 28
    • 33750007484 scopus 로고    scopus 로고
    • Gene Therapy for Cancer: Questions and Answers
    • National Cancer Institute Bethesda, MD, USA
    • Gene Therapy for Cancer: Questions and Answers. National Cancer Institute, Bethesda, MD, USA (2004). htt://www.cancer.gov/cancertopics/ factsheet/Therapy/gene
    • (2004)
  • 29
    • 33750031377 scopus 로고    scopus 로고
    • Pilot study of the use of the human hSlo/maxi-K. gene to treat erectile dysfunction
    • Discussion of Human Gene Transfer Protocol #0201-528
    • Pilot study of the use of the human hSlo/maxi-K. gene to treat erectile dysfunction. Recombinant DNA Advisory Committee Minutes of Meeting. Discussion of Human Gene Transfer Protocol #0201-528 (2002):9-13.
    • (2002) Recombinant DNA Advisory Committee Minutes of Meeting , pp. 9-13
  • 30
    • 0041920900 scopus 로고    scopus 로고
    • Ethics of phase 1 oncology studies: Re-examining the arguments and data
    • Agrawal M, Emanuel EJ: Ethics of phase 1 oncology studies: Re-examining the arguments and data. J Am Med Assoc (2003) 290(8):1075-1082.
    • (2003) J Am Med Assoc , vol.290 , Issue.8 , pp. 1075-1082
    • Agrawal, M.1    Emanuel, E.J.2
  • 31
    • 33745882459 scopus 로고    scopus 로고
    • Phase I oncology trials
    • In: Amdur R, Bankert E (Eds), Jones and Bartlett Publishers, Subdury, MA, USA
    • Miller M: Phase I oncology trials. In: Institutional Review Board: Management and Function. Amdur R, Bankert E (Eds), Jones and Bartlett Publishers, Subdury, MA, USA (2002):465-475.
    • (2002) Institutional Review Board: Management and Function , pp. 465-475
    • Miller, M.1
  • 34
    • 18444390927 scopus 로고    scopus 로고
    • Elements of style: Consent form language and the therapeutic misconception In phase 1 gene transfer trials
    • Kimmelman J, Levenstadt A: Elements of style: Consent form language and the therapeutic misconception In phase 1 gene transfer trials. Hum Gene Ther (2005) 16(4):502-508.
    • (2005) Hum Gene Ther , vol.16 , Issue.4 , pp. 502-508
    • Kimmelman, J.1    Levenstadt, A.2
  • 35
    • 0037180808 scopus 로고    scopus 로고
    • Descriptions of benefits and risks in consent forms for phase 1 oncology trials
    • Horng S, Emanuel EJ, Wilfond B, Rackoff J, Martz K, Grady C: Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med (2002) 347(26):2134-2140.
    • (2002) N Engl J Med , vol.347 , Issue.26 , pp. 2134-2140
    • Horng, S.1    Emanuel, E.J.2    Wilfond, B.3    Rackoff, J.4    Martz, K.5    Grady, C.6
  • 38
    • 0041706886 scopus 로고    scopus 로고
    • Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism
    • Horng S, Grady C: Misunderstanding in clinical research: Distinguishing therapeutic misconception, therapeutic misestimation, and therapeutic optimism. IRB Ethics & Human Research (2003) 25(1):11-16.
    • (2003) IRB Ethics & Human Research , vol.25 , Issue.1 , pp. 11-16
    • Horng, S.1    Grady, C.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.