메뉴 건너뛰기




Volumn 15, Issue 2, 2016, Pages 143-151

Do single-arm trials have a role in drug development plans incorporating randomised trials?

Author keywords

optimal development plans; phase II clinical trial design; randomised two arm; single arm

Indexed keywords

ANTINEOPLASTIC AGENT; BAVITUXIMAB; CARBOPLATIN; PACLITAXEL;

EID: 84962326240     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.1726     Document Type: Article
Times cited : (24)

References (36)
  • 4
    • 33845588585 scopus 로고    scopus 로고
    • Improving the design of phase II trials of cytostatic anticancer agents
    • Stone A, Wheeler C, Barge A,. Improving the design of phase II trials of cytostatic anticancer agents. Contemporary Clinical Trials 2007; 28: 138-45.
    • (2007) Contemporary Clinical Trials , vol.28 , pp. 138-145
    • Stone, A.1    Wheeler, C.2    Barge, A.3
  • 6
    • 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. European Journal of Cancer 2009; 45: 275-280.
    • (2009) European Journal of Cancer , vol.45 , pp. 275-280
    • Ratain, M.J.1    Sargent, D.J.2
  • 10
    • 78149240696 scopus 로고    scopus 로고
    • Randomized phase II trials: Misleading and unreliable
    • Stewart DJ,. Randomized phase II trials: misleading and unreliable. Journal of Clinical Oncology 2010; 28: e649-50.
    • (2010) Journal of Clinical Oncology , vol.28 , pp. e649-e650
    • Stewart, D.J.1
  • 14
    • 0026581740 scopus 로고
    • Planned versus attained design in phase II clinical trials
    • Green SJ, Dahlberg S,. Planned versus attained design in phase II clinical trials. Statistics in Medicine 1992; 11: 853-62.
    • (1992) Statistics in Medicine , vol.11 , pp. 853-862
    • Green, S.J.1    Dahlberg, S.2
  • 15
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • Simon R,. Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials 1989; 10: 1-10.
    • (1989) Controlled Clinical Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 16
    • 22344447501 scopus 로고    scopus 로고
    • Randomised phase II designs in cancer clinical trials: Current status and future directions
    • Lee JJ, Feng L,. Randomised phase II designs in cancer clinical trials: current status and future directions. Journal of Clinical Oncology 2005; 23: 4450-7.
    • (2005) Journal of Clinical Oncology , vol.23 , pp. 4450-4457
    • Lee, J.J.1    Feng, L.2
  • 18
    • 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
    • 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. Clinical Trials 2006; 3: 335-48.
    • (2006) Clinical Trials , vol.3 , pp. 335-348
    • Taylor, J.M.1    Braun, T.M.2    Li, Z.3
  • 20
    • 79960280722 scopus 로고    scopus 로고
    • Quantitative evaluation of single-arm versus randomized phase II cancer clinical trials
    • Pond GR, Abassi S,. Quantitative evaluation of single-arm versus randomized phase II cancer clinical trials. Clinical Trials 2011; 8: 260-9.
    • (2011) Clinical Trials , vol.8 , pp. 260-269
    • Pond, G.R.1    Abassi, S.2
  • 21
    • 84928125073 scopus 로고    scopus 로고
    • Comparison of single-arm versus randomized phase II clinical trials: A Bayesian approach
    • Sambucini V,. Comparison of single-arm versus randomized phase II clinical trials: a Bayesian approach. Journal of Biopharmaceutical Statistics 2015; 25: 474-89.
    • (2015) Journal of Biopharmaceutical Statistics , vol.25 , pp. 474-489
    • Sambucini, V.1
  • 22
    • 15244341760 scopus 로고    scopus 로고
    • Predicting the outcome of phase III trials using phase II data: A case study of clinical trial simulation in late stage drug development
    • De Ridder F,. Predicting the outcome of phase III trials using phase II data: a case study of clinical trial simulation in late stage drug development. Basic & Clinical Pharmacology & Toxicology 2005; 96: 235-41.
    • (2005) Basic & Clinical Pharmacology & Toxicology , vol.96 , pp. 235-241
    • De Ridder, F.1
  • 27
    • 77957937857 scopus 로고    scopus 로고
    • Two-stage designs optimal under the alternative hypothesis for phase II cancer clinical trials
    • Mander AP, Thompson SG,. Two-stage designs optimal under the alternative hypothesis for phase II cancer clinical trials. Contemporary Clinical Trials 2010; 31: 572-8.
    • (2010) Contemporary Clinical Trials , vol.31 , pp. 572-578
    • Mander, A.P.1    Thompson, S.G.2
  • 28
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan KKG, DeMets DL,. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 29
    • 0025633361 scopus 로고
    • Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk
    • Farrington CP, Manning G,. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Statistics in Medicine 1990; 9: 1447-54.
    • (1990) Statistics in Medicine , vol.9 , pp. 1447-1454
    • Farrington, C.P.1    Manning, G.2
  • 31
    • 84901187825 scopus 로고    scopus 로고
    • A review and re-interpretation of a group-sequential approach to sample size re-estimation in two stage trials
    • Bowden J, Mander A,. A review and re-interpretation of a group-sequential approach to sample size re-estimation in two stage trials. Pharmaceutical Statistics 2014; 13: 163-72.
    • (2014) Pharmaceutical Statistics , vol.13 , pp. 163-172
    • Bowden, J.1    Mander, A.2
  • 34
    • 84962321921 scopus 로고    scopus 로고
    • The next phase in oncology: FDA's Pazdur has new vision for drug development
    • Baghdadi R, Laffler MJ,. The next phase in oncology: FDA's Pazdur has new vision for drug development. The Pink Sheet 2013.
    • (2013) The Pink Sheet
    • Baghdadi, R.1    Laffler, M.J.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.