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Volumn 8, Issue 3, 2011, Pages 260-269

Quantitative evaluation of single-arm versus randomized phase II cancer clinical trials

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CANCER RESEARCH; METHODOLOGY; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POLICY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIMULATION; SYSTEMATIC ERROR;

EID: 79960280722     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774511401764     Document Type: Article
Times cited : (17)

References (22)
  • 1
    • 77956416153 scopus 로고    scopus 로고
    • Randomized phase II trials-inevitable or inadvisable?
    • Gan HK, Grothey A, Pond GR, et al. Randomized phase II trials-inevitable or inadvisable?. J Clin Oncol. 2010 ; 28: 2641-47
    • (2010) J Clin Oncol , vol.28 , pp. 2641-47
    • Gan, H.K.1    Grothey, A.2    Pond, G.R.3
  • 2
    • 57849154374 scopus 로고    scopus 로고
    • Optimising the design of phase II oncology trials: The importance of randomisation
    • Ratain MJ, Sargent DJ. Optimising the design of phase II oncology trials: the importance of randomisation. Eur J Cancer. 2009 ; 45: 275-80
    • (2009) Eur J Cancer , vol.45 , pp. 275-80
    • Ratain, M.J.1    Sargent, D.J.2
  • 4
    • 0037374498 scopus 로고    scopus 로고
    • The price of innovation: New estimates of drug development costs
    • DOI 10.1016/S0167-6296(02)00126-1
    • DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003 ; 22: 151-85 (Pubitemid 36279392)
    • (2003) Journal of Health Economics , vol.22 , Issue.2 , pp. 151-185
    • DiMasi, J.A.1    Hansen, R.W.2    Grabowski, H.G.3
  • 5
    • 33846995628 scopus 로고    scopus 로고
    • Economics of new oncology drug development
    • DOI 10.1200/JCO.2006.09.0803
    • DiMasi JA, Grabowski HG. Economics of new oncology drug development. J Clin Oncol. 2007 ; 25: 209-16 (Pubitemid 350003036)
    • (2007) Journal of Clinical Oncology , vol.25 , Issue.2 , pp. 209-216
    • DiMasi, J.A.1    Grabowski, H.G.2
  • 6
    • 33750455106 scopus 로고    scopus 로고
    • Comparing an experimental agent to a standard agent: Relative merits of a one-arm or randomized two-arm Phase II design
    • DOI 10.1177/1740774506070654
    • Taylor JM, Braun TM, Li Z. Comparing an experimental agent to a standard agent: relative merits of a one-arm or randomized two-arm Phase II design. Clin Trials. 2006 ; 3: 335-48 (Pubitemid 44645824)
    • (2006) Clinical Trials , vol.3 , Issue.4 , pp. 335-348
    • Taylor, J.M.G.1    Braun, T.M.2    Li, Z.3
  • 7
    • 79951742176 scopus 로고    scopus 로고
    • Excessive false-positive errors in single-arm phase II trials: A simulation-based analysis
    • Tang H, Foster NR, Grothey A, et al. Excessive false-positive errors in single-arm phase II trials: a simulation-based analysis. J Clin Oncol. 2009 ; 27: 15s - 15s
    • (2009) J Clin Oncol , vol.27
    • Tang, H.1    Foster, N.R.2    Grothey, A.3
  • 8
    • 70349671467 scopus 로고    scopus 로고
    • A comparison of phase II study strategies
    • Hunsberger S, Zhao Y, Simon R. A comparison of phase II study strategies. Clin Cancer Res. 2009 ; 15: 5950-55
    • (2009) Clin Cancer Res , vol.15 , pp. 5950-55
    • Hunsberger, S.1    Zhao, Y.2    Simon, R.3
  • 9
    • 22344447501 scopus 로고    scopus 로고
    • Randomized phase II designs in cancer clinical trials: Current status and future directions
    • DOI 10.1200/JCO.2005.03.197
    • Lee JJ, Feng L. Randomized phase II designs in cancer clinical trials: current status and future directions. J Clin Oncol. 2005 ; 23: 4450-57 (Pubitemid 46209969)
    • (2005) Journal of Clinical Oncology , vol.23 , Issue.19 , pp. 4450-4457
    • Lee, J.J.1    Feng, L.2
  • 10
    • 0033984551 scopus 로고    scopus 로고
    • Content and quality of currently published phase II cancer trials
    • Mariani L, Marubini E. Content and quality of currently published phase II cancer trials. J Clin Oncol. 2000 ; 18: 429-36 (Pubitemid 30056434)
    • (2000) Journal of Clinical Oncology , vol.18 , Issue.2 , pp. 429-436
    • Mariani, L.1    Marubini, E.2
  • 11
    • 0020108590 scopus 로고
    • One-sample multiple testing procedure for phase II clinical trials
    • Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 ; 38: 143-51
    • (1982) Biometrics , vol.38 , pp. 143-51
    • Fleming, T.R.1
  • 12
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • DOI 10.1016/0197-2456(89)90015-9
    • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 ; 10: 1-10 (Pubitemid 19099520)
    • (1989) Controlled Clinical Trials , vol.10 , Issue.1 , pp. 1-10
    • Simon, R.1
  • 13
    • 27244436755 scopus 로고    scopus 로고
    • Design issues of randomized phase II trials and a proposal for phase II screening trials
    • Rubinstein LV, Korn EL, Freidlin B, et al. Design issues of randomized phase II trials and a proposal for phase II screening trials. J Clin Oncol. 2005 ; 23: 7199-206
    • (2005) J Clin Oncol , vol.23 , pp. 7199-206
    • Rubinstein, L.V.1    Korn, E.L.2    Freidlin, B.3
  • 15
    • 39449091622 scopus 로고    scopus 로고
    • Randomized phase II trials with a prospective control
    • DOI 10.1002/sim.2961
    • Jung S-H. Randomized phase II trials with a prospective control. Stat Med. 2008 ; 27: 568-83 (Pubitemid 351266343)
    • (2008) Statistics in Medicine , vol.27 , Issue.4 , pp. 568-583
    • Jung, S.-H.1
  • 16
    • 0025005369 scopus 로고
    • Incorporating historical control data in planning phase II clinical trials
    • Thall PF, Simon R. Incorporating historical control data in planning phase II clinical trials. Stat Med. 1990 ; 9: 215-28 (Pubitemid 20252730)
    • (1990) Statistics in Medicine , vol.9 , Issue.3 , pp. 215-228
    • Thall, P.F.1    Simon, R.2
  • 17
    • 1142275380 scopus 로고    scopus 로고
    • Admissible two-stage designs for phase II cancer clinical trials
    • DOI 10.1002/sim.1600
    • Jung SH, Lee T, Kim K, George SL. Admissible two-stage designs for phase II cancer clinical trials. Stat Med. 2004 ; 23: 561-69 (Pubitemid 38208184)
    • (2004) Statistics in Medicine , vol.23 , Issue.4 , pp. 561-569
    • Jung, S.-H.1    Lee, T.2    Kim, K.M.3    George, S.L.4
  • 18
    • 4444272419 scopus 로고    scopus 로고
    • Dose-finding based on efficacy-toxicity trade-offs
    • DOI 10.1111/j.0006-341X.2004.00218.x
    • Thall PF, Cook JD. Dose-finding based on efficacy-toxicity trade-offs. Biometrics. 2004 ; 60: 684-93 (Pubitemid 39181113)
    • (2004) Biometrics , vol.60 , Issue.3 , pp. 684-693
    • Thall, P.F.1    Cook, J.D.2
  • 19
    • 49249102416 scopus 로고    scopus 로고
    • Phase II stopping rules that employ response rates and early progression
    • Goffin JR, Tu D. Phase II stopping rules that employ response rates and early progression. J Clin Oncol. 2008 ; 26: 3715-20
    • (2008) J Clin Oncol , vol.26 , pp. 3715-20
    • Goffin, J.R.1    Tu, D.2
  • 20
    • 37149053580 scopus 로고    scopus 로고
    • Design and conduct of phase II studies of targeted anticancer therapy: Recommendations from the task force on methodology for the development of innovative cancer therapies (MDICT)
    • DOI 10.1016/j.ejca.2007.07.031, PII S0959804907005904
    • Booth CM, Calvert AH, Giaccone G, et al. on behalf of the Task Force on Methodology for the Development of Innovative Cancer Therapies. Design and conduct of phase II studies of targeted anticancer therapy: recommendations from the task force on methodology for the development of innovative cancer therapies (MDICT). Eur J Cancer. 2008 ; 44: 25-29 (Pubitemid 350256934)
    • (2008) European Journal of Cancer , vol.44 , Issue.1 , pp. 25-29
    • Booth, C.M.1    Calvert, A.H.2    Giaccone, G.3    Lobbezoo, M.W.4    Eisenhauer, E.A.5    Seymour, L.K.6
  • 21
    • 74949139051 scopus 로고    scopus 로고
    • Ultimate fate of oncology drugs approved by the US Food and Drug Administration without a randomized trial
    • Tsimberidou A-M, Braiteh F, Stewart DJ, Kurzock R. Ultimate fate of oncology drugs approved by the US Food and Drug Administration without a randomized trial. J Clin Oncol. 2009 ; 27: 6243-49
    • (2009) J Clin Oncol , vol.27 , pp. 6243-49
    • Tsimberidou, A.-M.1    Braiteh, F.2    Stewart, D.J.3    Kurzock, R.4
  • 22
    • 67651061459 scopus 로고    scopus 로고
    • Current issues in oncology drug development, with a focus on phase II trials
    • Sargent DJ, Taylor JMG. Current issues in oncology drug development, with a focus on phase II trials. J Biopharm Stat. 2009 ; 19: 556-62
    • (2009) J Biopharm Stat , vol.19 , pp. 556-62
    • Sargent, D.J.1    Taylor, J.M.G.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.