메뉴 건너뛰기




Volumn 12, Issue 2, 2015, Pages 102-106

Are outcome-adaptive allocation trials ethical?

Author keywords

Adaptive randomization; equipoise; ethics; therapeutic misconception

Indexed keywords

CLINICAL DECISION MAKING; CLINICAL TRIAL (TOPIC); EQUIPOISE; HUMAN; INFORMED CONSENT; PRIORITY JOURNAL; RANDOMIZATION; RESEARCH ETHICS; REVIEW; SAMPLE SIZE; THERAPEUTIC MISCONCEPTION; VALIDITY; ETHICS; METHODOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC);

EID: 84924915397     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774514563583     Document Type: Review
Times cited : (94)

References (23)
  • 1
    • 2942711455 scopus 로고    scopus 로고
    • When are research risks reasonable in relation to anticipated benefits?
    • Weijer C, Miller PB. When are research risks reasonable in relation to anticipated benefits?. Nat Med. 2004 ; 10: 570-573
    • (2004) Nat Med , vol.10 , pp. 570-573
    • Weijer, C.1    Miller, P.B.2
  • 2
    • 34247159822 scopus 로고    scopus 로고
    • Steinbock B, ed. New York: Oxford University Press
    • London AJ The Oxford Handbook of Bioethics. Steinbock B, ed. New York: Oxford University Press ; 2007: 571-596.
    • (2007) The Oxford Handbook of Bioethics , pp. 571-596
    • London, A.J.1
  • 3
    • 28744450774 scopus 로고    scopus 로고
    • The use of unequal randomisation ratios in clinical trials: A review
    • Dumville JC, Hahn S, Miles JNV, et al. The use of unequal randomisation ratios in clinical trials: a review. Contemp Clin Trials. 2006 ; 27: 1-12
    • (2006) Contemp Clin Trials , vol.27 , pp. 1-12
    • Dumville, J.C.1    Hahn, S.2    Jnv, M.3
  • 4
    • 67649306739 scopus 로고    scopus 로고
    • Bayesian clinical trials at the university of Texas M.D. Anderson Cancer Center
    • Biswas S, Liu DD, Lee JJ, et al. Bayesian clinical trials at the university of Texas M.D. Anderson Cancer Center. Clin Trials. 2009 ; 6: 205-216
    • (2009) Clin Trials , vol.6 , pp. 205-216
    • Biswas, S.1    Liu, D.D.2    Lee, J.J.3
  • 5
    • 84865740846 scopus 로고    scopus 로고
    • Worth adapting? Revisiting the usefulness of outcome-adaptive randomization
    • Lee JJ, Chen N, Yin G. Worth adapting? Revisiting the usefulness of outcome-adaptive randomization. Clin Cancer Res. 2012 ; 18: 4498-4507
    • (2012) Clin Cancer Res , vol.18 , pp. 4498-4507
    • Lee, J.J.1    Chen, N.2    Yin, G.3
  • 6
    • 84862249598 scopus 로고    scopus 로고
    • Adaptive clinical trials: A partial remedy for the therapeutic misconception?
    • Meurer WJ, Lewis RJ, Berry DA. Adaptive clinical trials: a partial remedy for the therapeutic misconception?. JAMA. 2012 ; 307: 2377-2378
    • (2012) JAMA , vol.307 , pp. 2377-2378
    • Meurer, W.J.1    Lewis, R.J.2    Berry, D.A.3
  • 7
    • 84864687000 scopus 로고    scopus 로고
    • Bayesian adaptive trial design in acute heart failure syndromes: Moving beyond the mega trial
    • Collins SP, Lindsell CJ, Pang PS, et al. Bayesian adaptive trial design in acute heart failure syndromes: moving beyond the mega trial. Am Heart J. 2012 ; 164: 138-145
    • (2012) Am Heart J , vol.164 , pp. 138-145
    • Collins, S.P.1    Lindsell, C.J.2    Pang, P.S.3
  • 8
    • 84892169662 scopus 로고    scopus 로고
    • The questionable use of unequal allocation in confirmatory trials
    • Hey SP, Kimmelman J. The questionable use of unequal allocation in confirmatory trials. Neurology. 2014 ; 82: 77-79
    • (2014) Neurology , vol.82 , pp. 77-79
    • Hey, S.P.1    Kimmelman, J.2
  • 9
    • 34447572873 scopus 로고    scopus 로고
    • Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: Results of sarcoma alliance for research through collaboration study 002
    • Maki RG, Wathen JK, Patel SR, et al. Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002. J Clin Oncol. 2007 ; 25: 2755-2763
    • (2007) J Clin Oncol , vol.25 , pp. 2755-2763
    • Maki, R.G.1    Wathen, J.K.2    Patel, S.R.3
  • 10
    • 84883890647 scopus 로고    scopus 로고
    • Randomized open-label phase II study of decitabine in patients with low-or intermediate-risk myelodysplastic syndromes
    • Garcia-Manero G, Jabbour E, Borthakur G, et al. Randomized open-label phase II study of decitabine in patients with low-or intermediate-risk myelodysplastic syndromes. J Clin Oncol. 2013 ; 31: 2548-2553
    • (2013) J Clin Oncol , vol.31 , pp. 2548-2553
    • Garcia-Manero, G.1    Jabbour, E.2    Borthakur, G.3
  • 11
    • 0038811777 scopus 로고    scopus 로고
    • Adaptive randomized study of idarubicin and cytarabine versus troxacitabine and cytarabine versus troxacitabine and idarubicin in untreated patients 50 years or older with adverse karyotype acute myeloid leukemia
    • Giles FJ, Kantarjian HM, Cortes JE, et al. Adaptive randomized study of idarubicin and cytarabine versus troxacitabine and cytarabine versus troxacitabine and idarubicin in untreated patients 50 years or older with adverse karyotype acute myeloid leukemia. J Clin Oncol. 2003 ; 21: 1722-1727
    • (2003) J Clin Oncol , vol.21 , pp. 1722-1727
    • Giles, F.J.1    Kantarjian, H.M.2    Cortes, J.E.3
  • 12
    • 79957857433 scopus 로고    scopus 로고
    • The battle trial: Personalizing therapy for lung cancer
    • Kim ES, Herbst RS, Wistuba II, et al. The battle trial: personalizing therapy for lung cancer. Cancer Discov. 2011 ; 1: 44-53
    • (2011) Cancer Discov , vol.1 , pp. 44-53
    • Kim, E.S.1    Herbst, R.S.2    Wistuba, I.I.3
  • 13
    • 27244440177 scopus 로고    scopus 로고
    • Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens
    • Zia MI, Siu LL, Pond GR, et al. Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens. J Clin Oncol. 2005 ; 23: 6982-6991
    • (2005) J Clin Oncol , vol.23 , pp. 6982-6991
    • Zia, M.I.1    Siu, L.L.2    Pond, G.R.3
  • 14
    • 84892153139 scopus 로고    scopus 로고
    • Clinical development success rates for investigational drugs
    • Hay M, Thomas DW, Craighead JL, et al. Clinical development success rates for investigational drugs. Nature Biotechnol. 2014 ; 32: 40-51
    • (2014) Nature Biotechnol , vol.32 , pp. 40-51
    • Hay, M.1    Thomas, D.W.2    Craighead, J.L.3
  • 15
    • 84882985976 scopus 로고    scopus 로고
    • Trial unpredictability yields predictable therapy gains
    • Djulbegovic B, Kumar A, Glasziou P, et al. Trial unpredictability yields predictable therapy gains. Nature. 2013 ; 500: 395-396
    • (2013) Nature , vol.500 , pp. 395-396
    • Djulbegovic, B.1    Kumar, A.2    Glasziou, P.3
  • 16
    • 79952079839 scopus 로고    scopus 로고
    • Adaptive clinical trials: The promise and the caution
    • Berry DA. Adaptive clinical trials: the promise and the caution. J Clin Oncol. 2011 ; 29: 606-609
    • (2011) J Clin Oncol , vol.29 , pp. 606-609
    • Berry, D.A.1
  • 17
    • 77954875817 scopus 로고    scopus 로고
    • Silver Spring, MD: Office of Communication, Division of Drug Information, Center for Drug Evaluation and Research (accessed 5 December 2014)
    • Food and Drug Administration. Draft Guidance for industry: adaptive design clinical trials for drugs and biologics, Silver Spring, MD: Office of Communication, Division of Drug Information, Center for Drug Evaluation and Research, 2010. http://www.fda.gov/downloads/Drugs/... /Guidances/ucm201790.pdf (accessed 5 December 2014).
    • (2010) Food and Drug Administration. Draft Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics
  • 18
    • 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 ; 1: 11-16
    • (2003) IRB , vol.1 , pp. 11-16
    • Horng, S.1    Grady, C.2
  • 19
    • 0023319217 scopus 로고
    • False hopes and best data: Consent to research and the therapeutic misconception
    • Appelbaum PS, Roth LH, Lidz CW, et al. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep. 1987 ; 17: 20-24
    • (1987) Hastings Cent Rep , vol.17 , pp. 20-24
    • Appelbaum, P.S.1    Roth, L.H.2    Lidz, C.W.3
  • 20
    • 84924881492 scopus 로고    scopus 로고
    • Ethical considerations for outcome-adaptive trial designs: A clinical researcher's perspective
    • Saxman SB. Ethical considerations for outcome-adaptive trial designs: a clinical researcher's perspective. Bioethics. 2014 ;:
    • (2014) Bioethics
    • Saxman, S.B.1
  • 21
    • 84862257264 scopus 로고    scopus 로고
    • Adaptive trials in clinical research: Scientific and ethical issues to consider
    • Van der Graaf R, Roes KCB, van Delden JJM. Adaptive trials in clinical research: scientific and ethical issues to consider. JAMA. 2012 ; 307: 2379-2380
    • (2012) JAMA , vol.307 , pp. 2379-2380
    • Van Der Graaf, R.1    Kcb, R.2    Van Delden, J.J.M.3
  • 22
    • 78650339993 scopus 로고    scopus 로고
    • Outcome-adaptive randomization: Is it useful?
    • Korn EL, Freidlin B. Outcome-adaptive randomization: is it useful?. J Clin Oncol. 2011 ; 29: 771-776
    • (2011) J Clin Oncol , vol.29 , pp. 771-776
    • Korn, E.L.1    Freidlin, B.2
  • 23
    • 84903790421 scopus 로고    scopus 로고
    • Can response-adaptive randomization increase participation in acute stroke trials?
    • Tehranisa JS, Meurer WJ. Can response-adaptive randomization increase participation in acute stroke trials?. Stroke. 2014 ; 45: 2131-2133
    • (2014) Stroke , vol.45 , pp. 2131-2133
    • Tehranisa, J.S.1    Meurer, W.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.