메뉴 건너뛰기




Volumn 19, Issue 3, 2009, Pages 424-436

Optimal cost-effective designs of phase ii proof of concept trials and associated go-no go decisions

Author keywords

Confirmation trial; Oncology; Power; Treatment effect; Type I error rate

Indexed keywords

ARTICLE; CANCER THERAPY; CLINICAL EFFECTIVENESS; CLINICAL STUDY; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; DRUG DESIGN; DRUG INDUSTRY; DRUG MANUFACTURE; ERROR; HUMAN; METHODOLOGY; PRIORITY JOURNAL; PROBABILITY; PROOF OF CONCEPT; PUBLICATION; SAMPLE SIZE; COST BENEFIT ANALYSIS; DECISION THEORY; ECONOMICS; PHASE 2 CLINICAL TRIAL; STANDARD; STATISTICS;

EID: 67651027168     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400902800478     Document Type: Article
Times cited : (37)

References (11)
  • 1
    • 0037818705 scopus 로고    scopus 로고
    • New designs for Phase 2 clinical trials
    • Estey, E. H., Thall, P. F. (2003). New designs for Phase 2 clinical trials. Blood 102:442-448.
    • (2003) Blood , vol.102 , pp. 442-448
    • Estey, E.H.1    Thall, P.F.2
  • 2
    • 0035970746 scopus 로고    scopus 로고
    • The sample size for a clinical trial: A Bayesian-decision theoretic approach
    • Halpern, J., Brown, B. W., Hornberger, J. (2001). The sample size for a clinical trial: A Bayesian-decision theoretic approach. Stat. Med. 20:841-858.
    • (2001) Stat. Med. , vol.20 , pp. 841-858
    • Halpern, J.1    Brown, B.W.2    Hornberger, J.3
  • 3
    • 0035154256 scopus 로고    scopus 로고
    • Clinical trial designs for cytostatic agents: Are new approaches needed?
    • correspondence
    • Korn, E. L., Arbuck, S. G., Pluda, J. M. et al. (2001). Clinical trial designs for cytostatic agents: Are new approaches needed? J. Clin. Oncol. 19:265-272, 3154-3160 (correspondence)
    • (2001) J. Clin. Oncol. , vol.19 , Issue.265-272 , pp. 3154-3160
    • Korn, E.L.1    Arbuck, S.G.2    Pluda, J.M.3
  • 4
    • 0035019379 scopus 로고    scopus 로고
    • Bayesian assessment of sample size for clinical trials of cost-effectiveness
    • O'Hagan, A., Stevens, J. W. (2001). Bayesian assessment of sample size for clinical trials of cost-effectiveness. Med. Decision Making 21:219-230.
    • (2001) Med. Decision Making , vol.21 , pp. 219-230
    • O'Hagan, A.1    Stevens, J.W.2
  • 5
    • 28444445926 scopus 로고    scopus 로고
    • R Development Core Team. Vienna, Austria: R Foundation for Statistical Computing. ISBN 3-900051-07-0, URL
    • R Development Core Team. (2005). R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing. ISBN 3-900051-07-0, URL http://www.R-project.org.
    • (2005) R: A Language and Environment for Statistical Computing
  • 6
    • 27244436755 scopus 로고    scopus 로고
    • Design issues of randomized Phase II trials and a proposal for Phase II screening trials
    • Rubinstein, L. V., Korn, E. L., Freidlin, B. et al. (2005). Design issues of randomized Phase II trials and a proposal for Phase II screening trials. J. Clin. Oncol. 23:7199-7206.
    • (2005) J. Clin. Oncol. , vol.23 , pp. 7199-7206
    • Rubinstein, L.V.1    Korn, E.L.2    Freidlin, B.3
  • 7
    • 0035050901 scopus 로고    scopus 로고
    • A flexible design for multiple armed screening trials
    • Sargent, D. J., Goldberg, R. M. (2001). A flexible design for multiple armed screening trials. Stat. Med. 20:1051-1060.
    • (2001) Stat. Med. , vol.20 , pp. 1051-1060
    • Sargent, D.J.1    Goldberg, R.M.2
  • 8
    • 0024536437 scopus 로고
    • Optimal two-stage designs for Phase II clinical trials
    • Simon, R. (1989). Optimal two-stage designs for Phase II clinical trials. Contr. Clin. Trials 10:1-10.
    • (1989) Contr. Clin. Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 9
    • 0035868647 scopus 로고    scopus 로고
    • Clinical trial designs for the early clinical development of therapeutic cancer vaccines
    • Simon, R. M., Steinberg, S. M., Hamilton, M. et al. (2001). Clinical trial designs for the early clinical development of therapeutic cancer vaccines. J. Clin. Oncol. 19:1848-1854.
    • (2001) J. Clin. Oncol. , vol.19 , pp. 1848-1854
    • Simon, R.M.1    Steinberg, S.M.2    Hamilton, M.3
  • 10
    • 0035186577 scopus 로고    scopus 로고
    • Decision-theoretic designs for pre-Phase II screening trials in oncology
    • Stallard, N., Thall, P. F. (2001). Decision-theoretic designs for pre-Phase II screening trials in oncology. Biometrics 57:1089-1095.
    • (2001) Biometrics , vol.57 , pp. 1089-1095
    • Stallard, N.1    Thall, P.F.2
  • 11
    • 0036402789 scopus 로고    scopus 로고
    • Sample size calculations for a proof of concept study
    • Yin, Y. (2002). Sample size calculations for a proof of concept study. J. Biopharm. Stat. 12:267-276.
    • (2002) J. Biopharm. Stat. , vol.12 , pp. 267-276
    • Yin, Y.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.