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Volumn 32, Issue 9, 2006, Pages 548-553

Should desperate volunteers be included in randomised controlled trials?

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL STUDY; EXPERIMENTAL DESIGN; HEALTH CARE ACCESS; HEALTH CARE DELIVERY; INDIVIDUALITY; INFORMED CONSENT; MEDICAL EXPERT; PATIENT CARE; PATIENT PARTICIPATION; PHYSICIAN; PROFESSIONAL KNOWLEDGE; RANDOMIZATION; RESEARCH ETHICS; VOLUNTEER;

EID: 33748683775     PISSN: 03066800     EISSN: None     Source Type: Journal    
DOI: 10.1136/jme.2005.014282     Document Type: Article
Times cited : (17)

References (53)
  • 1
    • 33747031390 scopus 로고    scopus 로고
    • Improving the quality of consent to randomised controlled trials using continuous consent and clinician training in the consent process
    • Allmark P, Mason S. Improving the quality of consent to randomised controlled trials using continuous consent and clinician training in the consent process. J Med Ethics 2006;32:435-8.
    • (2006) J Med Ethics , vol.32 , pp. 435-438
    • Allmark, P.1    Mason, S.2
  • 2
    • 0029243278 scopus 로고
    • Individual autonomy and the double-blind controlled experiment - The case of desperate volunteers
    • Minogue BP, Palmerfernandez G, Udell L, et al. Individual autonomy and the double-blind controlled experiment - the case of desperate volunteers. J Med Philos 1995;20:43-55.
    • (1995) J Med Philos , vol.20 , pp. 43-55
    • Minogue, B.P.1    Palmerfernandez, G.2    Udell, L.3
  • 3
    • 0031796863 scopus 로고    scopus 로고
    • Drug testing and approval in cases of people with catastrophic illness: Ethical issues
    • Schuklenk U. Drug testing and approval in cases of people with catastrophic illness: ethical issues. Clin Res Regul Affairs 1998;15:145-57.
    • (1998) Clin Res Regul Affairs , vol.15 , pp. 145-157
    • Schuklenk, U.1
  • 4
    • 0038523941 scopus 로고    scopus 로고
    • Ethics of clinical trials from a Bayesian and decision analytic perspective: Whose equipoise is it anyway?
    • Lilford RJ. Ethics of clinical trials from a Bayesian and decision analytic perspective: whose equipoise is it anyway? BMJ 2003;326:980-1.
    • (2003) BMJ , vol.326 , pp. 980-981
    • Lilford, R.J.1
  • 7
    • 0034706254 scopus 로고    scopus 로고
    • For and against - Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial
    • Weijer C, Shapiro SH, Glass KC, et al. For and against - clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial. BMJ 2000;321:756-8.
    • (2000) BMJ , vol.321 , pp. 756-758
    • Weijer, C.1    Shapiro, S.H.2    Glass, K.C.3
  • 8
    • 0034916084 scopus 로고    scopus 로고
    • Uncertainty about clinical equipoise
    • Rolleston F. Uncertainty about clinical equipoise. Can Med Association J 2001;164:1831.
    • (2001) Can Med Association J , vol.164 , pp. 1831
    • Rolleston, F.1
  • 10
    • 0141797654 scopus 로고    scopus 로고
    • A critique of clinical equipoise - Therapeutic misconception in the ethics of clinical trials
    • Miller FG, Brody H. A critique of clinical equipoise - therapeutic misconception in the ethics of clinical trials. Hastings Cent Rep 2003;33:19-28.
    • (2003) Hastings Cent Rep , vol.33 , pp. 19-28
    • Miller, F.G.1    Brody, H.2
  • 11
    • 0141797660 scopus 로고    scopus 로고
    • Therapeutic obligation in clinical research
    • Weijer C, Miller PB. Therapeutic obligation in clinical research. Hastings Cent Rep 2003;33:3.
    • (2003) Hastings Cent Rep , vol.33 , pp. 3
    • Weijer, C.1    Miller, P.B.2
  • 12
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med 1987;317:141-5.
    • (1987) N Engl J Med , vol.317 , pp. 141-145
    • Freedman, B.1
  • 13
    • 0025973649 scopus 로고
    • At what level of collective equipoise does a clinical trial become ethical
    • Johnson N, Lilford RJ, Brazier W. At what level of collective equipoise does a clinical trial become ethical. J Med Ethics 1991;17:30-4.
    • (1991) J Med Ethics , vol.17 , pp. 30-34
    • Johnson, N.1    Lilford, R.J.2    Brazier, W.3
  • 14
    • 0029283812 scopus 로고
    • Community-equipoise and the ethics of randomized clinical trials
    • Gifford F. Community-equipoise and the ethics of randomized clinical trials. Bioethics 1995;9:127-48.
    • (1995) Bioethics , vol.9 , pp. 127-148
    • Gifford, F.1
  • 15
    • 2942517514 scopus 로고    scopus 로고
    • Equipoise, design bias, and randomized controlled trials: The elusive ethics of new drug development
    • Fries JF, Krishnan E. Equipoise, design bias, and randomized controlled trials: the elusive ethics of new drug development. Arthritis Res Ther 2004;6:R250-5.
    • (2004) Arthritis Res Ther , vol.6
    • Fries, J.F.1    Krishnan, E.2
  • 16
    • 0028792136 scopus 로고
    • Equipoise and the ethics of randomization
    • Lilford RJ, Jackson J. Equipoise and the ethics of randomization. J R Soc Med 1995;88:552-9.
    • (1995) J R Soc Med , vol.88 , pp. 552-559
    • Lilford, R.J.1    Jackson, J.2
  • 17
    • 0002321866 scopus 로고    scopus 로고
    • The misunderstood placebo
    • Senn S. The misunderstood placebo. Appl Clin Trials 2001;10:40-6.
    • (2001) Appl Clin Trials , vol.10 , pp. 40-46
    • Senn, S.1
  • 18
    • 0033780817 scopus 로고    scopus 로고
    • Freedman's 'clinical equipoise' and 'sliding-scale all-dimensions-considered equipoise'
    • Gifford F. Freedman's 'clinical equipoise' and 'sliding-scale all-dimensions-considered equipoise'. J Med Philos 2000;25:399-426.
    • (2000) J Med Philos , vol.25 , pp. 399-426
    • Gifford, F.1
  • 19
    • 0038528532 scopus 로고    scopus 로고
    • Indifference of subjects: An alternative to equipoise in randomized clinical trials
    • Veatch RM. Indifference of subjects: an alternative to equipoise in randomized clinical trials. Soc Philos Policy 2002;19:295-323.
    • (2002) Soc Philos Policy , vol.19 , pp. 295-323
    • Veatch, R.M.1
  • 20
    • 0842307625 scopus 로고    scopus 로고
    • Equipoise: Beyond rehabilitation?
    • Menikoff J. Equipoise: Beyond rehabilitation? Kennedy Inst Ethics J 2003;13:347-51.
    • (2003) Kennedy Inst Ethics J , vol.13 , pp. 347-351
    • Menikoff, J.1
  • 21
    • 0037514503 scopus 로고    scopus 로고
    • The ubiquity and utility of the therapeutic misconception
    • Dresser R. The ubiquity and utility of the therapeutic misconception. Soc Philos Policy 2002;19:271-94.
    • (2002) Soc Philos Policy , vol.19 , pp. 271-294
    • Dresser, R.1
  • 22
    • 1542783693 scopus 로고    scopus 로고
    • Clinical equipoise and the therapeutic misconception - Franklin G. Miller and Howard Brody reply
    • Glass KC. Clinical equipoise and the therapeutic misconception - Franklin G. Miller and Howard Brody reply. Hastings Cent Rep 2003;33:4-6.
    • (2003) Hastings Cent Rep , vol.33 , pp. 4-6
    • Glass, K.C.1
  • 23
    • 1442311081 scopus 로고    scopus 로고
    • Therapeutic misconception and the appreciation of risks in clinical trials
    • Lidz CW, Appelbaum PS, Grisso T, et al. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med 2004;58:1689-97.
    • (2004) Soc Sci Med , vol.58 , pp. 1689-1697
    • Lidz, C.W.1    Appelbaum, P.S.2    Grisso, T.3
  • 24
    • 1542783693 scopus 로고    scopus 로고
    • Clinical equipoise and the therapeutic misconception
    • Mann H, Djulbegovic B. Clinical equipoise and the therapeutic misconception. Hastings Cent Rep 2003;33:4.
    • (2003) Hastings Cent Rep , vol.33 , pp. 4
    • Mann, H.1    Djulbegovic, B.2
  • 25
    • 0037417240 scopus 로고    scopus 로고
    • The therapeutic orientation to clinical trials
    • Miller FG, Rosenstein DL. The therapeutic orientation to clinical trials. N Engl J Med 2003;348:1383-6.
    • (2003) N Engl J Med , vol.348 , pp. 1383-1386
    • Miller, F.G.1    Rosenstein, D.L.2
  • 26
    • 0034737962 scopus 로고    scopus 로고
    • What makes clinical research ethical?
    • Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701-11.
    • (2000) JAMA , vol.283 , pp. 2701-2711
    • Emanuel, E.J.1    Wendler, D.2    Grady, C.3
  • 27
    • 0842264331 scopus 로고    scopus 로고
    • The clinician-investigator: Unavoidable but manageable tension
    • Brody H, Miller FG. The clinician-investigator: unavoidable but manageable tension. Kennedy Inst Ethics J 2003;13:329-46.
    • (2003) Kennedy Inst Ethics J , vol.13 , pp. 329-346
    • Brody, H.1    Miller, F.G.2
  • 28
    • 0034079699 scopus 로고    scopus 로고
    • Challenges in the conduct and interpretation of Phase II (pilot) randomized trials
    • Yusuf S. Challenges in the conduct and interpretation of Phase II (pilot) randomized trials. Am Heart J 2000;139:S136-42.
    • (2000) Am Heart J , vol.139
    • Yusuf, S.1
  • 29
    • 0037306203 scopus 로고    scopus 로고
    • Be skeptical about unexpected large apparent treatment effects: The case of an MRC AML12 randomization
    • Wheatley K, Clayton D. Be skeptical about unexpected large apparent treatment effects: the case of an MRC AML12 randomization. Cont Clin Trials 2003;24:66-70.
    • (2003) Cont Clin Trials , vol.24 , pp. 66-70
    • Wheatley, K.1    Clayton, D.2
  • 30
    • 0032458718 scopus 로고    scopus 로고
    • Ethical issues in the design and conduct of randomised controlled trials
    • Edwards SJ, Lilford RJ, Braunholtz DA, et al. Ethical issues in the design and conduct of randomised controlled trials. Health Technol Assess 1998;2:1-132.
    • (1998) Health Technol Assess , vol.2 , pp. 1-132
    • Edwards, S.J.1    Lilford, R.J.2    Braunholtz, D.A.3
  • 31
    • 0035828458 scopus 로고    scopus 로고
    • Equipoise is not synonymous with uncertainty
    • Lilford RJ. Equipoise is not synonymous with uncertainty. BMJ 2001;323:574-5.
    • (2001) BMJ , vol.323 , pp. 574-575
    • Lilford, R.J.1
  • 32
    • 85007654812 scopus 로고    scopus 로고
    • Quinacrine in possible or probable CJD - If you had suspected CJD would you be indifferent between placebo and quinacrine?
    • Braunholtz D, Harris J. Quinacrine in possible or probable CJD - if you had suspected CJD would you be indifferent between placebo and quinacrine? BMJ 2002;324:239.
    • (2002) BMJ , vol.324 , pp. 239
    • Braunholtz, D.1    Harris, J.2
  • 34
    • 0012744510 scopus 로고    scopus 로고
    • Adequate and well-controlled trials
    • Food and Drug Administration. Code of Federal Regulations [revised 1 Apr 2001]. Part 314.126. Washington, DC: US Government Printing Office
    • Food and Drug Administration. Adequate and well-controlled trials. Code of Federal Regulations [revised 1 Apr 2001]. 21 Part 314.126. Washington, DC: US Government Printing Office, 2001.
    • (2001) , vol.21
  • 35
    • 0035180445 scopus 로고    scopus 로고
    • The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: An FDA perspective
    • Laughren TP. The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective. Eur Psychiatry 2001;16:418-23.
    • (2001) Eur Psychiatry , vol.16 , pp. 418-423
    • Laughren, T.P.1
  • 36
    • 1642419746 scopus 로고    scopus 로고
    • Research ethics and the use of the placebo: The state of the debate
    • Keating B. Research ethics and the use of the placebo: the state of the debate. MS Med Sci 2004;20:118-25.
    • (2004) MS Med Sci , vol.20 , pp. 118-125
    • Keating, B.1
  • 37
    • 0037389433 scopus 로고    scopus 로고
    • Update on unethical use of placebos in randomised trials
    • Michels KB, Rothman KJ. Update on unethical use of placebos in randomised trials. Bioethics 2003;17:188-204.
    • (2003) Bioethics , vol.17 , pp. 188-204
    • Michels, K.B.1    Rothman, K.J.2
  • 38
    • 0037108228 scopus 로고    scopus 로고
    • Policy developments in regulatory approval
    • Temple R. Policy developments in regulatory approval. Stat Med 2002;21:2939-48.
    • (2002) Stat Med , vol.21 , pp. 2939-2948
    • Temple, R.1
  • 40
    • 0034293342 scopus 로고    scopus 로고
    • Clinical problem solving and decision psychology: Comment on "The epistemology of clinical reasoning"
    • Elstein AS. Clinical problem solving and decision psychology: comment on "The epistemology of clinical reasoning". Acad Med 2000; 75:S134-6.
    • (2000) Acad Med , vol.75
    • Elstein, A.S.1
  • 44
    • 0016732180 scopus 로고
    • Iatrogenic hazards and their effects
    • Smithells R. Iatrogenic hazards and their effects. Postgrad Med 1995;51(Suppl 2):39-52.
    • (1995) Postgrad Med , vol.51 , Issue.SUPPL. 2 , pp. 39-52
    • Smithells, R.1
  • 45
    • 0029855591 scopus 로고    scopus 로고
    • Human guinea pigs and the ethics of experimentation: The BMJ's correspondent at the Nuremberg medical trial
    • Weindling P. Human guinea pigs and the ethics of experimentation: the BMJ's correspondent at the Nuremberg medical trial. BMJ 1996;313:1467-70.
    • (1996) BMJ , vol.313 , pp. 1467-1470
    • Weindling, P.1
  • 46
    • 0029969769 scopus 로고    scopus 로고
    • Not a slippery slope or sudden subversion: German medicine and national socialism in 1933
    • Hanauske-Abel HM. Not a slippery slope or sudden subversion: German medicine and national socialism in 1933. BMJ 1996;313:1453-63.
    • (1996) BMJ , vol.313 , pp. 1453-1463
    • Hanauske-Abel, H.M.1
  • 47
    • 0036717915 scopus 로고    scopus 로고
    • Voluntariness of consent for research - An empirical and conceptual review
    • Nelson RM, Merz JF. Voluntariness of consent for research - an empirical and conceptual review. Med Care 2002;40:69-80.
    • (2002) Med Care , vol.40 , pp. 69-80
    • Nelson, R.M.1    Merz, J.F.2
  • 48
    • 19444372433 scopus 로고    scopus 로고
    • Patient preferences in randomised controlled trials: Conceptual framework and implications for research
    • Bower P, King M, Nazareth I, et al. Patient preferences in randomised controlled trials: conceptual framework and implications for research. Soc Sci Med 2005;61:685-95.
    • (2005) Soc Sci Med , vol.61 , pp. 685-695
    • Bower, P.1    King, M.2    Nazareth, I.3
  • 49
    • 0024980660 scopus 로고
    • Patient preferences and randomized clinical trials
    • Brewin CR, Bradley C. Patient preferences and randomized clinical trials. BMJ 1989;299:313-15.
    • (1989) BMJ , vol.299 , pp. 313-315
    • Brewin, C.R.1    Bradley, C.2
  • 50
    • 0242522164 scopus 로고    scopus 로고
    • Issues to debate on the Women's Health Initiative (WHI) study. Epidemiology or randomized clinical trials-time out for hormone replacement therapy studies?
    • Pedersen AT, Ottesen B. Issues to debate on the Women's Health Initiative (WHI) study. Epidemiology or randomized clinical trials-time out for hormone replacement therapy studies? Hum Reprod 2003;18:2241-4.
    • (2003) Hum Reprod , vol.18 , pp. 2241-2244
    • Pedersen, A.T.1    Ottesen, B.2
  • 51
    • 0026660156 scopus 로고
    • Statistical and ethical issues in monitoring clinical-trials
    • [reprinted from]
    • Pocock SJ. Statistical and ethical issues in monitoring clinical-trials [reprinted from BMJ, 1992;305:235-40].
    • (1992) BMJ , vol.305 , pp. 235-240
    • Pocock, S.J.1
  • 53
    • 0033118672 scopus 로고    scopus 로고
    • Ethics and practice: Alternative designs for phase III randomized clinical trials
    • Palmer CR, Rosenberger WF. Ethics and practice: alternative designs for phase III randomized clinical trials. Cont Clin Trials 1999;20:172-86.
    • (1999) Cont Clin Trials , vol.20 , pp. 172-186
    • Palmer, C.R.1    Rosenberger, W.F.2


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