메뉴 건너뛰기




Volumn 8, Issue 1, 2014, Pages

The ethics of clinical trials

Author keywords

Ethics; Personalized medicine; Precision medicine; RCTs; Research

Indexed keywords


EID: 84894542159     PISSN: None     EISSN: 17546605     Source Type: Journal    
DOI: 10.3332/ecancer.2014.387     Document Type: Article
Times cited : (97)

References (39)
  • 3
    • 84894597964 scopus 로고    scopus 로고
    • World Medical Association.Last accessed 14/10/13
    • World Medical Association (2008) Declaration of Helsinki, 6th revision Available at http://www.wma.net/en/30publications/10policies/b3/. Last accessed 14/10/13.
    • (2008) Declaration of Helsinki, 6th Revision
  • 6
    • 85078418040 scopus 로고    scopus 로고
    • Causality, Impartiality and Evidence-Based Policy Ěd Chao H-K, Cheng S-T and Millstein RL
    • the Netherlands: Springer. doi: 10.1007/978-94-007-2454-9-11
    • Teira D and Reiss J (2013) Causality, Impartiality and Evidence-Based Policy ed Chao H-K, Cheng S-T and Millstein RL Mechanism and Causality in Biology and Economics pp 207-24 (the Netherlands: Springer). DOI: 10.1007/978-94-007-2454-9-11
    • (2013) Mechanism and Causality in Biology and Economics , pp. 207-224
    • Teira, D.1    Reiss, J.2
  • 7
    • 0033564491 scopus 로고    scopus 로고
    • Toward evidence-based medical statistics 1: The P value fallacy
    • doi: 10.7326/0003-4819-130-12-199906150-00008 PMID: 10383371
    • Goodman SN (1999) Toward evidence-based medical statistics. 1: the P value fallacy Ann Intern Med 130 995. DOI: 10.7326/0003-4819-130-12-199906150- 00008 PMID: 10383371
    • (1999) Ann Intern Med , vol.130 , pp. 995
    • Goodman, S.N.1
  • 10
    • 0026723801 scopus 로고
    • Informed consent: Is it a myth?
    • doi: 10.1227/00006123-199203000-00028 PMID: 1620316
    • Herz DA, Looman JE and Lewis SK (1992) Informed consent: is it a myth? Neurosurgery 30(3) 453-8. DOI: 10.1227/00006123-199203000-00028 PMID: 1620316
    • (1992) Neurosurgery , vol.30 , Issue.3 , pp. 453-458
    • Herz, D.A.1    Looman, J.E.2    Lewis, S.K.3
  • 12
    • 0141797654 scopus 로고    scopus 로고
    • A critique of clinical equipoise: Therapeutic misconception in the ethics of clinical trials
    • doi: 10.2307/3528434 PMID: 12854452
    • Miller F and Brody H (2003) A critique of clinical equipoise: therapeutic misconception in the ethics of clinical trials Hastings Cent Rep 33 19-28. DOI: 10.2307/3528434 PMID: 12854452
    • (2003) Hastings Cent Rep , vol.33 , pp. 19-28
    • Miller, F.1    Brody, H.2
  • 13
    • 1642354885 scopus 로고    scopus 로고
    • Deception in the pursuit of science
    • doi: 10.1001/archinte.164.6.597 PMID: 15037487
    • Wendler D and Miller F (2004) Deception in the pursuit of science Arch Intern Med 164 597-600. DOI: 10.1001/archinte.164.6.597 PMID: 15037487
    • (2004) Arch Intern Med , vol.164 , pp. 597-600
    • Wendler, D.1    Miller, F.2
  • 14
    • 84856746620 scopus 로고    scopus 로고
    • Challenges of clinical trial design when there is lack of clinical equipoise: Use of a response conditional crossover design
    • doi: 10.1007/s00415-011-6200-0 PMCID: 3268968
    • Deng C et al (2012) Challenges of clinical trial design when there is lack of clinical equipoise: use of a response conditional crossover design J Neurol 259 348-52. DOI: 10.1007/s00415-011-6200-0 PMCID: 3268968
    • (2012) J Neurol , vol.259 , pp. 348-352
    • Deng, C.1
  • 15
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues
    • doi: 10.7326/0003-4819-133-6-200009190-00014 PMID: 10975964
    • Temple R and Ellenberg SS (2000) Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues Ann Intern Med 133(6) 455-63. DOI: 10.7326/0003-4819-133-6- 200009190-00014 PMID: 10975964
    • (2000) Ann Intern Med , vol.133 , Issue.6 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 16
    • 32344444114 scopus 로고    scopus 로고
    • The ethics and science of placebo-controlled trials: Assay sensitivity and the Duhem-Quine thesis
    • doi: 10.1080/03605310500499203 PMID: 16464770
    • Anderson JA (2006) The ethics and science of placebo-controlled trials: assay sensitivity and the Duhem-Quine thesis J Med Philos 31 65-81. DOI: 10.1080/03605310500499203 PMID: 16464770
    • (2006) J Med Philos , vol.31 , pp. 65-81
    • Anderson, J.A.1
  • 17
    • 70449589963 scopus 로고    scopus 로고
    • Questioning the methodologic superiority of 'placebo' over 'active' controlled trials
    • Howick J (2009) Questioning the methodologic superiority of 'placebo' over 'active' controlled trials AJoB 9 34-48.
    • (2009) AJoB , vol.9 , pp. 34-48
    • Howick, J.1
  • 18
    • 0025906439 scopus 로고
    • Of mice but not men: Problems of the randomized clinical trial
    • doi: 10.1056/NEJM199105303242208 PMID: 2027362
    • Hellman S and Hellman DS (1991) Of mice but not men: problems of the randomized clinical trial N Engl J Med 324(22) 1585-9. DOI: 10.1056/ NEJM199105303242208 PMID: 2027362
    • (1991) N Engl J Med , vol.324 , Issue.22 , pp. 1585-1589
    • Hellman, S.1    Hellman, D.S.2
  • 19
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • doi: 10.1056/NEJM198707163170304 PMID: 3600702
    • Freedman B (1987) Equipoise and the ethics of clinical research N Engl J Med 317 141-5. DOI: 10.1056/NEJM198707163170304 PMID: 3600702
    • (1987) N Engl J Med , vol.317 , pp. 141-145
    • Freedman, B.1
  • 20
    • 0032458718 scopus 로고    scopus 로고
    • Ethical issues in the design and conduct of randomised controlled trials
    • Edwards SJ et al (1998) Ethical issues in the design and conduct of randomised controlled trials Health Technol Assess 2(15) 1-132.
    • (1998) Health Technol Assess , vol.2 , Issue.15 , pp. 1-132
    • Edwards, S.J.1
  • 21
    • 0034595429 scopus 로고    scopus 로고
    • Why randomized controlled trials fail but needn't: 1. Failure to gain "coal-face"commitment and to use the uncertainty principle
    • PMID: 10813014 PMCID: 1232415
    • Sackett D (2000) Why randomized controlled trials fail but needn't: 1. failure to gain "coal-face"commitment and to use the uncertainty principle CMAJ 162 1311-14. PMID: 10813014 PMCID: 1232415
    • (2000) CMAJ , vol.162 , pp. 1311-1314
    • Sackett, D.1
  • 22
    • 0038523941 scopus 로고    scopus 로고
    • Ethics of clinical trials from a Bayesian and decision-analitic perspective: Whose equipoise is it anyway?
    • doi: 10.1136/bmj.326.7396.980 PMID: 12727776 PMCID: 1125887
    • Lilford RJ (2003) Ethics of clinical trials from a Bayesian and decision-analitic perspective: whose equipoise is it anyway? BMJ 326 980-81. DOI: 10.1136/bmj.326.7396.980 PMID: 12727776 PMCID: 1125887
    • (2003) BMJ , vol.326 , pp. 980-981
    • Lilford, R.J.1
  • 23
    • 0033118672 scopus 로고    scopus 로고
    • Ethics and practice: Alternative designs for phase III randomized clinical trials
    • doi: 10.1016/S0197-2456(98)00056-7 PMID: 10227416
    • Palmer CR and Rosenberger WF (1999) Ethics and practice: alternative designs for phase III randomized clinical trials Control Clin Trials 20(2) 172-86. DOI: 10.1016/S0197-2456(98)00056-7 PMID: 10227416
    • (1999) Control Clin Trials , vol.20 , Issue.2 , pp. 172-186
    • Palmer, C.R.1    Rosenberger, W.F.2
  • 24
    • 0032199750 scopus 로고    scopus 로고
    • Research in developing countries: Taking "benefit"seriously
    • doi: 10.2307/3528268 PMID: 9868610
    • Glantz LH et al (1998) Research in developing countries: taking "benefit"seriously Hastings Cent Rep 28 38-42. DOI: 10.2307/3528268 PMID: 9868610
    • (1998) Hastings Cent Rep , vol.28 , pp. 38-42
    • Glantz, L.H.1
  • 25
    • 0035849989 scopus 로고    scopus 로고
    • Ethical issues in the design and conduct of clinical trials in developing countries
    • doi: 10.1056/NEJM200107123450212 PMID: 11450665
    • Shapiro H and E Meslin (2001) Ethical issues in the design and conduct of clinical trials in developing countries N Engl J Med 345 139-42. DOI: 10.1056/NEJM200107123450212 PMID: 11450665
    • (2001) N Engl J Med , vol.345 , pp. 139-142
    • Shapiro, H.1    Meslin, E.2
  • 26
    • 14144255867 scopus 로고    scopus 로고
    • Thirty years of bioethics: The Helsinki Declaration 1964-2003
    • doi: 10.1080/1740028032000131396
    • Riis P (2003) Thirty years of bioethics: the Helsinki Declaration 1964-2003 New Rev Bioeth 1 15-25. DOI: 10.1080/1740028032000131396
    • (2003) New Rev Bioeth , vol.1 , pp. 15-25
    • Riis, P.1
  • 27
    • 34250622864 scopus 로고    scopus 로고
    • Facing up to paternalism in research ethics
    • doi: 10.1353/hcr.2007.0044 PMID: 17649900
    • Miller FG and Wertheimer A (2007) Facing up to paternalism in research ethics Hastings Cent Rep 37(3) 24-34. DOI: 10.1353/hcr.2007.0044 PMID: 17649900
    • (2007) Hastings Cent Rep , vol.37 , Issue.3 , pp. 24-34
    • Miller, F.G.1    Wertheimer, A.2
  • 28
    • 33846504444 scopus 로고    scopus 로고
    • Compressing drug development timelines in oncology using phase '0' trials
    • doi: 10.1038/nrc2066 PMID: 17251919
    • Kummar S et al (2007) Compressing drug development timelines in oncology using phase '0' trials Nat Rev Cancer 7(2) 131-9. DOI: 10.1038/nrc2066 PMID: 17251919
    • (2007) Nat Rev Cancer , vol.7 , Issue.2 , pp. 131-139
    • Kummar, S.1
  • 29
    • 77958106228 scopus 로고    scopus 로고
    • The 2008 Declaration of Helsinki: Some reflections
    • doi: 10.1136/jme.2009.034132 PMID: 20813718
    • Giordano S (2010) The 2008 Declaration of Helsinki: some reflections J Med Ethics 36 598-603. DOI: 10.1136/jme.2009.034132 PMID: 20813718
    • (2010) J Med Ethics , vol.36 , pp. 598-603
    • Giordano, S.1
  • 30
    • 0037097838 scopus 로고    scopus 로고
    • Randomised trials in surgery: Problems and possible solutions
    • doi: 10.1136/bmj.324.7351.1448 PMID: 12065273 PMCID: 1123389
    • McCulloch P et al (2002) Randomised trials in surgery: problems and possible solutions BMJ 324 1448-51. DOI: 10.1136/bmj.324.7351.1448 PMID: 12065273 PMCID: 1123389
    • (2002) BMJ , vol.324 , pp. 1448-1451
    • McCulloch, P.1
  • 31
    • 39049163022 scopus 로고    scopus 로고
    • Structural genomic variation and personalized medicine
    • doi: 10.1056/NEJMcibr0708452 PMID: 18272898
    • Lee C and Morton CC (2008) Structural genomic variation and personalized medicine N Engl J Med 358(7) 740-41. DOI: 10.1056/NEJMcibr0708452 PMID: 18272898
    • (2008) N Engl J Med , vol.358 , Issue.7 , pp. 740-741
    • Lee, C.1    Morton, C.C.2
  • 32
    • 84857820489 scopus 로고    scopus 로고
    • Tumor heterogeneity and personalized medicine
    • doi: 10.1056/NEJMe1200656 PMID: 22397658
    • Longo Dan L (2012) Tumor heterogeneity and personalized medicine N Engl J Med 366(10) 956-7. DOI: 10.1056/NEJMe1200656 PMID: 22397658
    • (2012) N Engl J Med , vol.366 , Issue.10 , pp. 956-957
    • Longo Dan, L.1
  • 33
    • 77957876459 scopus 로고    scopus 로고
    • Personalized medicine's ragged edge
    • doi: 10.1353/hcr.2010.0005 PMID: 20964159
    • Fleck LM (2010) Personalized medicine's ragged edge Hastings Cent Rep 40(5) 16-18. DOI: 10.1353/hcr.2010.0005 PMID: 20964159
    • (2010) Hastings Cent Rep , vol.40 , Issue.5 , pp. 16-18
    • Fleck, L.M.1
  • 34
    • 79952419254 scopus 로고    scopus 로고
    • Methodological and practical challenges for personalized cancer therapies
    • doi: 10.1038/nrclinonc.2011.2
    • Wistuba II et al (2012) Methodological and practical challenges for personalized cancer therapies Nat Rev Clin Oncol 8 135-41. DOI: 10.1038/nrclinonc.2011.2
    • (2012) Nat Rev Clin Oncol , vol.8 , pp. 135-141
    • Wistuba, I.I.1
  • 35
    • 84859377987 scopus 로고    scopus 로고
    • Role of randomized phase III trials in an era of effective targeted therapies
    • doi: 10.1038/nrclinonc.2011.190
    • Sharma MR and Schilsky RL (2012) Role of randomized phase III trials in an era of effective targeted therapies Nat Rev Clin Oncol 9(4) 208-14. DOI: 10.1038/nrclinonc.2011.190
    • (2012) Nat Rev Clin Oncol , vol.9 , Issue.4 , pp. 208-214
    • Sharma, M.R.1    Schilsky, R.L.2
  • 36
    • 0037125417 scopus 로고    scopus 로고
    • The continuing unethical conduct of underpowered clinical trials
    • doi: 10.1001/jama.288.3.358 PMID: 12117401
    • Halpern SD, Karlawish JHT and Berlin JA (2002) The continuing unethical conduct of underpowered clinical trials JAMA 288 358-62. DOI: 10.1001/jama.288.3.358 PMID: 12117401
    • (2002) JAMA , vol.288 , pp. 358-362
    • Halpern, S.D.1    Karlawish, J.H.T.2    Berlin, J.A.3
  • 37
    • 84875946700 scopus 로고    scopus 로고
    • Are randomized trials obsolete or more important than ever in the genomic era?
    • doi: 10.1186/gm436 PMID: 23673134 PMCID: 3707036
    • Ioannidis JPA and Khoury MJ (2013) Are randomized trials obsolete or more important than ever in the genomic era? Genome Med 5 32. DOI: 10.1186/gm436 PMID: 23673134 PMCID: 3707036
    • (2013) Genome Med , vol.5 , pp. 32
    • Ioannidis, J.P.A.1    Khoury, M.J.2
  • 38
    • 49749128052 scopus 로고    scopus 로고
    • Evidence and ethics in medicine
    • doi: 10.1353/pbm.0.0040 PMID: 18723945
    • Worrall J (2008) Evidence and ethics in medicine Perspect Biol Med 51(3) 418-31. DOI: 10.1353/pbm.0.0040 PMID: 18723945
    • (2008) Perspect Biol Med , vol.51 , Issue.3 , pp. 418-431
    • Worrall, J.1
  • 39
    • 84866647476 scopus 로고    scopus 로고
    • Mechanistic understanding in clinical practice: Complementing evidence-based medicine with personalized medicine
    • PMID: 22994998
    • Nardini C, Annoni M and Schiavone G (2012) Mechanistic understanding in clinical practice: complementing evidence-based medicine with personalized medicine J Eval Clin Pract 18(5) 1000-5. PMID: 22994998
    • (2012) J Eval Clin Pract , vol.18 , Issue.5 , pp. 1000-1005
    • Nardini, C.1    Annoni, M.2    Schiavone, G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.