메뉴 건너뛰기




Volumn 118, Issue 18, 2012, Pages 4571-4578

Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials

Author keywords

clinical trials; ethics; informed consent; phase 1; therapeutic misconception

Indexed keywords

ADULT; AGED; ALTRUISM; ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; EDUCATION; FEMALE; HUMAN; INCOME; MAJOR CLINICAL STUDY; MALE; MOTIVATION; OPTIMISM; PESSIMISM; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROBABILITY; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; THERAPEUTIC MISCONCEPTION;

EID: 84865974488     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.27397     Document Type: Article
Times cited : (127)

References (39)
  • 1
    • 0027083055 scopus 로고
    • Ethical issues in phase i oncology research: A comparison of investigators and institutional review board chairpersons
    • Kodish E, Stocking C, Ratain MJ, Kohrman A, Siegler M,. Ethical issues in phase I oncology research: a comparison of investigators and institutional review board chairpersons. J Clin Oncol. 1992; 10: 1810-1816.
    • (1992) J Clin Oncol , vol.10 , pp. 1810-1816
    • Kodish, E.1    Stocking, C.2    Ratain, M.J.3    Kohrman, A.4    Siegler, M.5
  • 2
    • 0029002997 scopus 로고
    • Perceptions of cancer patients and their physicians involved in phase i trials
    • Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995; 13: 1062-1072.
    • (1995) J Clin Oncol , vol.13 , pp. 1062-1072
    • Daugherty, C.1    Ratain, M.J.2    Grochowski, E.3
  • 3
    • 0029068812 scopus 로고
    • A phase i trial on the ethics of phase i trials
    • Emanuel EJ,. A phase I trial on the ethics of phase I trials. J Clin Oncol. 1995; 13: 1049-1051.
    • (1995) J Clin Oncol , vol.13 , pp. 1049-1051
    • Emanuel, E.J.1
  • 4
    • 0041920900 scopus 로고    scopus 로고
    • Ethics of phase 1 oncology studies: Reexamining the arguments and data
    • Agrawal M, Emanuel EJ,. Ethics of phase 1 oncology studies: reexamining the arguments and data. JAMA. 2003; 290: 1075-1082.
    • (2003) JAMA , vol.290 , pp. 1075-1082
    • Agrawal, M.1    Emanuel, E.J.2
  • 5
    • 33746013190 scopus 로고    scopus 로고
    • Rethinking risk-benefit assessment for phase i cancer trials
    • Joffe S, Miller FG,. Rethinking risk-benefit assessment for phase I cancer trials. J Clin Oncol. 2006; 24: 2987-2990.
    • (2006) J Clin Oncol , vol.24 , pp. 2987-2990
    • Joffe, S.1    Miller, F.G.2
  • 6
    • 0029927575 scopus 로고    scopus 로고
    • The impact of disease severity on the informed consent process in clinical research
    • Schaeffer MH, Krantz DS, Wichman A, Masur H, Reed E, Vinicky JK,. The impact of disease severity on the informed consent process in clinical research. Am J Med. 1996; 100: 261-268.
    • (1996) Am J Med , vol.100 , pp. 261-268
    • Schaeffer, M.H.1    Krantz, D.S.2    Wichman, A.3    Masur, H.4    Reed, E.5    Vinicky, J.K.6
  • 7
    • 0035900908 scopus 로고    scopus 로고
    • Quality of informed consent: A new measure of understanding among research subjects
    • Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC,. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001; 93: 139-147.
    • (2001) J Natl Cancer Inst , vol.93 , pp. 139-147
    • Joffe, S.1    Cook, E.F.2    Cleary, P.D.3    Clark, J.W.4    Weeks, J.C.5
  • 8
    • 0034189187 scopus 로고    scopus 로고
    • Quantitative analysis of ethical issues in phase i trials: A survey interview of 144 advanced cancer patients
    • Daugherty CK, Banik DM, Janish L, Ratain MJ,. Quantitative analysis of ethical issues in phase I trials: a survey interview of 144 advanced cancer patients. IRB. 2000; 22: 6-14.
    • (2000) IRB , vol.22 , pp. 6-14
    • Daugherty, C.K.1    Banik, D.M.2    Janish, L.3    Ratain, M.J.4
  • 9
    • 0030950354 scopus 로고    scopus 로고
    • Patients in phase i trials of anti-cancer agents in Japan: Motivation, comprehension and expectations
    • Itoh K, Sasaki Y, Fujii H, et al. Patients in phase I trials of anti-cancer agents in Japan: motivation, comprehension and expectations. Br J Cancer. 1997; 76: 107-113.
    • (1997) Br J Cancer , vol.76 , pp. 107-113
    • Itoh, K.1    Sasaki, Y.2    Fujii, H.3
  • 11
    • 67649998571 scopus 로고    scopus 로고
    • An intervention to improve cancer patient's understanding of early-phase clinical trials
    • Kass N, Fogarty L, Sugarman J, et al. An intervention to improve cancer patient's understanding of early-phase clinical trials. IRB. 2009; 31: 1-10.
    • (2009) IRB , vol.31 , pp. 1-10
    • Kass, N.1    Fogarty, L.2    Sugarman, J.3
  • 12
    • 61449282532 scopus 로고    scopus 로고
    • Benefit in phase 1 oncology trials: Therapeutic misconception or reasonable treatment option?
    • Miller FG, Joffe S,. Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option? Clin Trials. 2008; 5: 617-623.
    • (2008) Clin Trials , vol.5 , pp. 617-623
    • Miller, F.G.1    Joffe, S.2
  • 13
    • 14544284502 scopus 로고    scopus 로고
    • Risks and benefits of phase 1 oncology trials, 1991 through 2002
    • Horstmann E, McCabe MS, Grochow L, et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med. 2005; 352: 895-904.
    • (2005) N Engl J Med , vol.352 , pp. 895-904
    • Horstmann, E.1    McCabe, M.S.2    Grochow, L.3
  • 14
    • 33846165079 scopus 로고    scopus 로고
    • Evaluating the therapeutic misconception
    • Miller FG, Joffe S,. Evaluating the therapeutic misconception. Kennedy Inst Ethics J. 2006; 16: 353-366.
    • (2006) Kennedy Inst Ethics J , vol.16 , pp. 353-366
    • Miller, F.G.1    Joffe, S.2
  • 15
    • 33846183282 scopus 로고    scopus 로고
    • Re-evaluating the therapeutic misconception: Response to Miller and Joffe
    • Appelbaum PS, Lidz CW,. Re-evaluating the therapeutic misconception: response to Miller and Joffe. Kennedy Inst Ethics J. 2006; 16: 367-373.
    • (2006) Kennedy Inst Ethics J , vol.16 , pp. 367-373
    • Appelbaum, P.S.1    Lidz, C.W.2
  • 16
    • 61449442413 scopus 로고    scopus 로고
    • Early phase clinical trials: Communicating the uncertainties of "magnitude of benefit" and "likelihood of benefit."
    • discussion 630.
    • Kass NE,. Early phase clinical trials: communicating the uncertainties of "magnitude of benefit" and "likelihood of benefit." Clin Trials. 2008; 5: 627-629; discussion 630.
    • (2008) Clin Trials , vol.5 , pp. 627-629
    • Kass, N.E.1
  • 17
    • 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. 2003; 25: 11-16.
    • (2003) IRB , vol.25 , pp. 11-16
    • Horng, S.1    Grady, C.2
  • 18
    • 0242383541 scopus 로고    scopus 로고
    • Patient expectations of benefit from phase i clinical trials: Linguistic considerations in diagnosing a therapeutic misconception
    • Weinfurt KP, Sulmasy DP, Schulman KA, Meropol NJ,. Patient expectations of benefit from phase I clinical trials: linguistic considerations in diagnosing a therapeutic misconception. Theor Med Bioeth. 2003; 24: 329-344.
    • (2003) Theor Med Bioeth , vol.24 , pp. 329-344
    • Weinfurt, K.P.1    Sulmasy, D.P.2    Schulman, K.A.3    Meropol, N.J.4
  • 19
    • 79951822397 scopus 로고    scopus 로고
    • Unrealistic optimism in early-phase oncology trials
    • Jansen LA, Appelbaum PS, Klein WM, et al. Unrealistic optimism in early-phase oncology trials. IRB. 2011; 33: 1-8.
    • (2011) IRB , vol.33 , pp. 1-8
    • Jansen, L.A.1    Appelbaum, P.S.2    Klein, W.M.3
  • 20
  • 21
    • 0020390058 scopus 로고
    • The therapeutic misconception: Informed consent in psychiatric research
    • Appelbaum PS, Roth LH, Lidz C,. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry. 1982; 5: 319-329.
    • (1982) Int J Law Psychiatry , vol.5 , pp. 319-329
    • Appelbaum, P.S.1    Roth, L.H.2    Lidz, C.3
  • 22
    • 36849069884 scopus 로고    scopus 로고
    • Clinical trials and medical care: Defining the therapeutic misconception [serial online]
    • Henderson GE, Churchill LR, Davis AM, et al. Clinical trials and medical care: defining the therapeutic misconception [serial online]. PLoS Med. 2007; 4: e324.
    • (2007) PLoS Med , vol.4
    • Henderson, G.E.1    Churchill, L.R.2    Davis, A.M.3
  • 23
    • 42149126151 scopus 로고    scopus 로고
    • What should research participants understand to understand they are participants in research?
    • Wendler D, Grady C,. What should research participants understand to understand they are participants in research? Bioethics. 2008; 22: 203-208.
    • (2008) Bioethics , vol.22 , pp. 203-208
    • Wendler, D.1    Grady, C.2
  • 24
    • 47249134621 scopus 로고    scopus 로고
    • Expectations of benefit in early-phase clinical trials: Implications for assessing the adequacy of informed consent
    • Weinfurt KP, Seils DM, Tzeng JP, et al. Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent. Med Decis Making. 2008; 28: 575-581.
    • (2008) Med Decis Making , vol.28 , pp. 575-581
    • Weinfurt, K.P.1    Seils, D.M.2    Tzeng, J.P.3
  • 25
    • 0035873327 scopus 로고    scopus 로고
    • The association between treatment-specific optimism and depressive symptomatology in patients enrolled in a phase i cancer clinical trial
    • Cohen L, de Moor C, Amato RJ,. The association between treatment-specific optimism and depressive symptomatology in patients enrolled in a phase I cancer clinical trial. Cancer. 2001; 91: 1949-1955.
    • (2001) Cancer , vol.91 , pp. 1949-1955
    • Cohen, L.1    De Moor, C.2    Amato, R.J.3
  • 26
    • 0141954204 scopus 로고    scopus 로고
    • Associations among awareness of prognosis, hopefulness, and coping in patients with advanced cancer participating in phase i clinical trials
    • Helft PR, Hlubocky F, Wen M, Daugherty CK,. Associations among awareness of prognosis, hopefulness, and coping in patients with advanced cancer participating in phase I clinical trials. Support Care Cancer. 2003; 11: 644-651.
    • (2003) Support Care Cancer , vol.11 , pp. 644-651
    • Helft, P.R.1    Hlubocky, F.2    Wen, M.3    Daugherty, C.K.4
  • 27
    • 33748496245 scopus 로고    scopus 로고
    • The problem with optimism in clinical trials
    • Jansen LA,. The problem with optimism in clinical trials. IRB. 2006; 28: 13-19.
    • (2006) IRB , vol.28 , pp. 13-19
    • Jansen, L.A.1
  • 29
    • 0038339691 scopus 로고    scopus 로고
    • The correlation between patient characteristics and expectations of benefit from phase i clinical trials
    • Weinfurt KP, Castel LD, Li Y, et al. The correlation between patient characteristics and expectations of benefit from phase I clinical trials. Cancer. 2003; 98: 166-175.
    • (2003) Cancer , vol.98 , pp. 166-175
    • Weinfurt, K.P.1    Castel, L.D.2    Li, Y.3
  • 31
    • 33646078330 scopus 로고    scopus 로고
    • Volunteering for early phase gene transfer research in Parkinson disease
    • Kim SY, Holloway RG, Frank S, et al. Volunteering for early phase gene transfer research in Parkinson disease. Neurology. 2006; 66: 1010-1015.
    • (2006) Neurology , vol.66 , pp. 1010-1015
    • Kim, S.Y.1    Holloway, R.G.2    Frank, S.3
  • 33
    • 2342438949 scopus 로고    scopus 로고
    • People at the end of life are a vulnerable research population
    • Hawryluck L,. People at the end of life are a vulnerable research population. Clin Oncol (R Coll Radiol). 2004; 16: 225-226.
    • (2004) Clin Oncol (R Coll Radiol) , vol.16 , pp. 225-226
    • Hawryluck, L.1
  • 34
    • 33748154209 scopus 로고    scopus 로고
    • Vulnerable populations in research: The case of the seriously ill
    • Nickel PJ,. Vulnerable populations in research: the case of the seriously ill. Theor Med Bioeth. 2006; 27: 245-264.
    • (2006) Theor Med Bioeth , vol.27 , pp. 245-264
    • Nickel, P.J.1
  • 35
    • 0025353690 scopus 로고
    • Responses and toxic deaths in phase i clinical trials
    • Decoster G, Stein G, Holdener EE,. Responses and toxic deaths in phase I clinical trials. Ann Oncol. 1990; 1: 175-181.
    • (1990) Ann Oncol , vol.1 , pp. 175-181
    • Decoster, G.1    Stein, G.2    Holdener, E.E.3
  • 36
    • 0030044379 scopus 로고    scopus 로고
    • Design and results of phase I cancer clinical trials: 3-Year experience at M. D. Anderson Cancer Center
    • Smith TL, Lee JJ, Kantarjian HM, Legha SS, Raber MN,. Design and results of phase I cancer clinical trials: 3-year experience at M. D. Anderson Cancer Center. J Clin Oncol. 1996; 14: 287-295.
    • (1996) J Clin Oncol , vol.14 , pp. 287-295
    • Smith, T.L.1    Lee, J.J.2    Kantarjian, H.M.3    Legha, S.S.4    Raber, M.N.5
  • 37
    • 0034573353 scopus 로고    scopus 로고
    • Defining and describing benefit appropriately in clinical trials
    • King NM,. Defining and describing benefit appropriately in clinical trials. J Law Med Ethics. 2000; 28: 332-343.
    • (2000) J Law Med Ethics , vol.28 , pp. 332-343
    • King, N.M.1
  • 38
    • 38349057569 scopus 로고    scopus 로고
    • Participants in phase 1 oncology research trials: Are they vulnerable?
    • Seidenfeld J, Horstmann E, Emanuel EJ, Grady C,. Participants in phase 1 oncology research trials: are they vulnerable? Arch Intern Med. 2008; 168: 16-20.
    • (2008) Arch Intern Med , vol.168 , pp. 16-20
    • Seidenfeld, J.1    Horstmann, E.2    Emanuel, E.J.3    Grady, C.4
  • 39
    • 79951990094 scopus 로고    scopus 로고
    • What oncologists believe they said and what patients believe they heard: An analysis of phase i trial discussions
    • Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ,. What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011; 29: 61-68.
    • (2011) J Clin Oncol , vol.29 , pp. 61-68
    • Jenkins, V.1    Solis-Trapala, I.2    Langridge, C.3    Catt, S.4    Talbot, D.C.5    Fallowfield, L.J.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.