메뉴 건너뛰기




Volumn 39, Issue 9, 2008, Pages 2627-2636

Practical model-based dose finding in early-phase clinical trials: Optimizing tissue plasminogen activator dose for treatment of ischemic stroke in children

Author keywords

Bayesian statistics; Dose finding; Phase I II trial; Stroke; TPA

Indexed keywords

FIBRINOLYTIC AGENT; TISSUE PLASMINOGEN ACTIVATOR;

EID: 52449120660     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/STROKEAHA.107.510164     Document Type: Review
Times cited : (18)

References (31)
  • 1
    • 0028788018 scopus 로고
    • Cerebrovascular disease in children under 16 years of age in the city of Dijon, France: A study of incidence and clinical features from 1985 to 1993
    • Giroud M, Lemesle M, Gouyon JB, Nivelon JL, Milan C, Dumas R. Cerebrovascular disease in children under 16 years of age in the city of Dijon, France: a study of incidence and clinical features from 1985 to 1993. J Clin Epidemiol. 1995;48:1343-1348.
    • (1995) J Clin Epidemiol , vol.48 , pp. 1343-1348
    • Giroud, M.1    Lemesle, M.2    Gouyon, J.B.3    Nivelon, J.L.4    Milan, C.5    Dumas, R.6
  • 3
    • 0034084410 scopus 로고    scopus 로고
    • Neurologic outcome in survivors of childhood arterial ischemic stroke and sinovenous thrombosis
    • deVeber GA, MacGregor D, Curtis R, Mayank S. Neurologic outcome in survivors of childhood arterial ischemic stroke and sinovenous thrombosis. J Child Neurol. 2000;15:316-324.
    • (2000) J Child Neurol , vol.15 , pp. 316-324
    • deVeber, G.A.1    MacGregor, D.2    Curtis, R.3    Mayank, S.4
  • 4
    • 66949151899 scopus 로고    scopus 로고
    • The financial burden of pediatric stroke cannot be undermined in the United States
    • Janjua N, Nasar A, Mohammad Y, Qureshi AI. The financial burden of pediatric stroke cannot be undermined in the United States. Stroke. 2006;37:498.
    • (2006) Stroke , vol.37 , pp. 498
    • Janjua, N.1    Nasar, A.2    Mohammad, Y.3    Qureshi, A.I.4
  • 5
    • 0028783948 scopus 로고    scopus 로고
    • Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med. 1995;333:1581-1587.
    • Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med. 1995;333:1581-1587.
  • 6
    • 0343118114 scopus 로고    scopus 로고
    • The NINDS t-PA Stroke Study Group
    • Intracerebral hemorrhage after intravenous t-PA therapy for ischemic stroke
    • Intracerebral hemorrhage after intravenous t-PA therapy for ischemic stroke. The NINDS t-PA Stroke Study Group. Stroke 1997;28: 2109-2118.
    • (1997) Stroke , vol.28 , pp. 2109-2118
  • 8
    • 66949130049 scopus 로고    scopus 로고
    • Eligibility for hyperacute thrombolytic therapy with tissue plasminogen activator (tPA) in children
    • Rafay M, Pontigon A, Chiang J, Jarvis A, Silver F, MacGregor D, deVeber GA. Eligibility for hyperacute thrombolytic therapy with tissue plasminogen activator (tPA) in children. Ann Neurol. 2006;60:142-143.
    • (2006) Ann Neurol , vol.60 , pp. 142-143
    • Rafay, M.1    Pontigon, A.2    Chiang, J.3    Jarvis, A.4    Silver, F.5    MacGregor, D.6    deVeber, G.A.7
  • 11
    • 0024274311 scopus 로고
    • Age dependence of blood fibrinolytic components and the effects of low-dose oral contraceptives on coagulation and fibrinolysis in teenagers
    • Siegbahn A, Ruusuvaara L. Age dependence of blood fibrinolytic components and the effects of low-dose oral contraceptives on coagulation and fibrinolysis in teenagers. Thromb Haemost. 1988;60:361-364.
    • (1988) Thromb Haemost , vol.60 , pp. 361-364
    • Siegbahn, A.1    Ruusuvaara, L.2
  • 14
    • 34249811795 scopus 로고    scopus 로고
    • Thrombolysis for ischemic stroke in children: Data from the nationwide inpatient sample
    • Janjua N, Nasar A, Lynch JK, Qureshi AI. Thrombolysis for ischemic stroke in children: data from the nationwide inpatient sample. Stroke. 2007;38:1850-1854.
    • (2007) Stroke , vol.38 , pp. 1850-1854
    • Janjua, N.1    Nasar, A.2    Lynch, J.K.3    Qureshi, A.I.4
  • 15
    • 4444272419 scopus 로고    scopus 로고
    • Dose-finding based on efficacy-toxicity trade-offs
    • Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics. 2004;60:684-693.
    • (2004) Biometrics , vol.60 , pp. 684-693
    • Thall, P.F.1    Cook, J.D.2
  • 16
    • 20444408490 scopus 로고    scopus 로고
    • Clinical trials: Is the Bayesian approach ready for prime time? Yes!
    • Berry DA. Clinical trials: is the Bayesian approach ready for prime time? Yes! Stroke. 2005;36:1621-1622.
    • (2005) Stroke , vol.36 , pp. 1621-1622
    • Berry, D.A.1
  • 17
    • 0029027770 scopus 로고
    • Some practical improvements in the continual reassessment method for phase I studies
    • Goodman SN, Zahurak ML, Piantadosi S. Some practical improvements in the continual reassessment method for phase I studies. Stat Med. 1995;14:1149-1161.
    • (1995) Stat Med , vol.14 , pp. 1149-1161
    • Goodman, S.N.1    Zahurak, M.L.2    Piantadosi, S.3
  • 18
    • 0642346184 scopus 로고    scopus 로고
    • Practical model-based dose-finding in phase I clinical trials: Methods based on toxicity
    • Thall PF, Lee SJ. Practical model-based dose-finding in phase I clinical trials: methods based on toxicity. Int J Gynecol Cancer. 2003;13: 251-261.
    • (2003) Int J Gynecol Cancer , vol.13 , pp. 251-261
    • Thall, P.F.1    Lee, S.J.2
  • 19
    • 0027562635 scopus 로고
    • Hemorrhagic transformation after cerebral ischemia: Mechanisms and incidence
    • Lyden PD, Zivin JA. Hemorrhagic transformation after cerebral ischemia: mechanisms and incidence. Cerebrovasc Brain Metab Rev. 1993;5:1-16.
    • (1993) Cerebrovasc Brain Metab Rev , vol.5 , pp. 1-16
    • Lyden, P.D.1    Zivin, J.A.2
  • 20
    • 7644227043 scopus 로고    scopus 로고
    • Wang X, Tsuji K, Lee SR, Ning M, Furie KL, Buchan AM, Lo EH. Mechanisms of hemorrhagic transformation after tissue plasminogen activator reperfusion therapy for ischemic stroke. Stroke 2004;35(suppl I):I-2726 -I-2730.
    • Wang X, Tsuji K, Lee SR, Ning M, Furie KL, Buchan AM, Lo EH. Mechanisms of hemorrhagic transformation after tissue plasminogen activator reperfusion therapy for ischemic stroke. Stroke 2004;35(suppl I):I-2726 -I-2730.
  • 21
    • 33751584603 scopus 로고    scopus 로고
    • Adaptive dose selection using efficacy-toxicity trade-offs: Illustrations and practical considerations
    • Thall PF, Cook JD, Estey EH. Adaptive dose selection using efficacy-toxicity trade-offs: illustrations and practical considerations. J Biopharm Stat. 2006;16:623-638.
    • (2006) J Biopharm Stat , vol.16 , pp. 623-638
    • Thall, P.F.1    Cook, J.D.2    Estey, E.H.3
  • 22
    • 35348891441 scopus 로고    scopus 로고
    • Some geometric methods for constructing decision criteria based on two-dimensional parameters
    • Thall PF. Some geometric methods for constructing decision criteria based on two-dimensional parameters. J Stat Planning Inference. 2008; 138:516-527.
    • (2008) J Stat Planning Inference , vol.138 , pp. 516-527
    • Thall, P.F.1
  • 23
    • 33947511484 scopus 로고    scopus 로고
    • The impact of recanalization on ischemic stroke outcome: A meta-analysis
    • Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke. 2007;38:967-973.
    • (2007) Stroke , vol.38 , pp. 967-973
    • Rha, J.H.1    Saver, J.L.2
  • 24
    • 33846118364 scopus 로고    scopus 로고
    • Predictors for recanali-zation after intravenous thrombolysis in acute ischemic stroke
    • Tandberg Askevold E, Naess H, Thomassen L. Predictors for recanali-zation after intravenous thrombolysis in acute ischemic stroke. J Stroke Cerebrovasc Dis. 2007;16:21-24.
    • (2007) J Stroke Cerebrovasc Dis , vol.16 , pp. 21-24
    • Tandberg Askevold, E.1    Naess, H.2    Thomassen, L.3
  • 25
    • 0035201206 scopus 로고    scopus 로고
    • Safety and outcomes of thrombolysis with tissue plas-minogen activator for treatment of intravascular thrombosis in children
    • Gupta AA, Leaker M, Andrew M, Massicotte P, Liu L, Benson LN, McCrindle BW. Safety and outcomes of thrombolysis with tissue plas-minogen activator for treatment of intravascular thrombosis in children. J Pediatr. 2001;139:682-688.
    • (2001) J Pediatr , vol.139 , pp. 682-688
    • Gupta, A.A.1    Leaker, M.2    Andrew, M.3    Massicotte, P.4    Liu, L.5    Benson, L.N.6    McCrindle, B.W.7
  • 26
    • 0027949027 scopus 로고
    • Simulation as a design tool for phase I/II clinical trials: An example from bone marrow transplantation
    • Gooley TA, Martin PJ, Fisher LD, Pettinger M. Simulation as a design tool for phase I/II clinical trials: an example from bone marrow transplantation. Control ClinTrials. 1994;15:450-462.
    • (1994) Control ClinTrials , vol.15 , pp. 450-462
    • Gooley, T.A.1    Martin, P.J.2    Fisher, L.D.3    Pettinger, M.4
  • 27
    • 0035186085 scopus 로고    scopus 로고
    • Dose-finding designs for HIV studies
    • O'Quigley J, Hughes MD, Fenton T. Dose-finding designs for HIV studies. Biometrics. 2001;57:1018 -1029.
    • (2001) Biometrics , vol.57 , pp. 1018-1029
    • O'Quigley, J.1    Hughes, M.D.2    Fenton, T.3
  • 28
    • 0036277621 scopus 로고    scopus 로고
    • The bivariate continual reassessment method: Extending the CRM to phase I trials of two competing outcomes
    • Braun TM. The bivariate continual reassessment method: extending the CRM to phase I trials of two competing outcomes. Control Clin Trials. 2002;23:240-256.
    • (2002) Control Clin Trials , vol.23 , pp. 240-256
    • Braun, T.M.1
  • 29
    • 0346102888 scopus 로고    scopus 로고
    • A new dose-finding design for bivariate outcomes
    • Ivanova A. A new dose-finding design for bivariate outcomes. Biometrics. 2003;59:1001-1007.
    • (2003) Biometrics , vol.59 , pp. 1001-1007
    • Ivanova, A.1
  • 30
    • 20744435134 scopus 로고    scopus 로고
    • A Bayesian approach to jointly modeling toxicity and biomarker expression in a phase I/II dose-finding trial
    • Bekele BN, Shen Y. A Bayesian approach to jointly modeling toxicity and biomarker expression in a phase I/II dose-finding trial. Biometrics. 2005;61:343-354.
    • (2005) Biometrics , vol.61 , pp. 343-354
    • Bekele, B.N.1    Shen, Y.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.