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Volumn 31, Issue 11-12, 2012, Pages 1031-1042

Optimal sample sizes for phase II clinical trials and pilot studies

Author keywords

Adaptive programmes of clinical development; Bayesian decision theory; Clinical trial design

Indexed keywords

ARTICLE; BAYES THEOREM; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PILOT STUDY; PROCESS OPTIMIZATION; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL DISTRIBUTION; STATISTICAL MODEL; STUDY DESIGN;

EID: 84861183854     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.4357     Document Type: Article
Times cited : (81)

References (21)
  • 1
    • 0022072879 scopus 로고
    • Designing phase II studies in the context of a programme of clinical research
    • Whitehead J. Designing phase II studies in the context of a programme of clinical research. Biometrics 1985; 41:373-383.
    • (1985) Biometrics , vol.41 , pp. 373-383
    • Whitehead, J.1
  • 2
    • 0022784374 scopus 로고
    • Sample sizes for phase II and phase III clinical trials: an integrated approach
    • Whitehead J. Sample sizes for phase II and phase III clinical trials: an integrated approach. Statistics in Medicine 1986; 5:459-464.
    • (1986) Statistics in Medicine , vol.5 , pp. 459-464
    • Whitehead, J.1
  • 3
    • 0038545822 scopus 로고    scopus 로고
    • Decision-theoretic designs for phase II clinical trials allowing for competing studies
    • Stallard N. Decision-theoretic designs for phase II clinical trials allowing for competing studies. Biometrics 2003; 59:402-409.
    • (2003) Biometrics , vol.59 , pp. 402-409
    • Stallard, N.1
  • 4
    • 15844411320 scopus 로고    scopus 로고
    • Moving statistics beyond the individual clinical trial: applying decision science to optimize a clinical development plan
    • Julious SA, Swank DJ. Moving statistics beyond the individual clinical trial: applying decision science to optimize a clinical development plan. Pharmaceutical Statistics 2005; 4:37-46.
    • (2005) Pharmaceutical Statistics , vol.4 , pp. 37-46
    • Julious, S.A.1    Swank, D.J.2
  • 5
    • 0029843087 scopus 로고    scopus 로고
    • Optimal sample size for a series of pilot trials of new agents
    • Yao T-J, Begg CB, Livingston PO. Optimal sample size for a series of pilot trials of new agents. Biometrics 1996; 52:992-1001.
    • (1996) Biometrics , vol.52 , pp. 992-1001
    • Yao, T.-J.1    Begg, C.B.2    Livingston, P.O.3
  • 6
    • 0031679258 scopus 로고    scopus 로고
    • Optimal two-hand design for a series of pilot trials of new agents
    • Yao T-J, Venkatraman ES. Optimal two-hand design for a series of pilot trials of new agents. Biometrics 1998; 54:1183-1189.
    • (1998) Biometrics , vol.54 , pp. 1183-1189
    • Yao, T.-J.1    Venkatraman, E.S.2
  • 7
    • 0345404433 scopus 로고    scopus 로고
    • An optimal design for screening trials
    • Wang Y-G, Leung DHY. An optimal design for screening trials. Biometrics 1998; 54:245-252.
    • (1998) Biometrics , vol.54 , pp. 245-252
    • Wang, Y.-G.1    Leung, D.H.Y.2
  • 8
    • 49749135478 scopus 로고    scopus 로고
    • Bayesian optimal design for phase II screening trials
    • Ding M, Rosner GL, Müller P. Bayesian optimal design for phase II screening trials. Biometrics 2008; 64:886-894.
    • (2008) Biometrics , vol.64 , pp. 886-894
    • Ding, M.1    Rosner, G.L.2    Müller, P.3
  • 11
    • 70149113077 scopus 로고    scopus 로고
    • R Development Core Team. R Foundation for Statistical Computing: Vienna, Austria
    • R Development Core Team. R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing: Vienna, Austria, 2009.
    • (2009) R: A Language and Environment for Statistical Computing
  • 14
    • 20444438736 scopus 로고    scopus 로고
    • Benefit-risk evaluation of multi-hand adaptive designs
    • Liu Q, Anderson K, Pledger GW. Benefit-risk evaluation of multi-hand adaptive designs. Sequential Analysis 2004; 23:317-331.
    • (2004) Sequential Analysis , vol.23 , pp. 317-331
    • Liu, Q.1    Anderson, K.2    Pledger, G.W.3
  • 15
    • 0038539843 scopus 로고
    • Exact computational analyses for adaptive designs
    • Flournoy N, Rosenberger WF (eds). IMS: Hayward, CA
    • Hardwick JP, Stout QF. Exact computational analyses for adaptive designs. In Adaptive Designs, Flournoy N, Rosenberger WF (eds). IMS: Hayward, CA, 1995; 223-237.
    • (1995) Adaptive Designs , pp. 223-237
    • Hardwick, J.P.1    Stout, Q.F.2
  • 16
    • 0031898459 scopus 로고    scopus 로고
    • Sample size determination for phase II clinical trials based on Bayesian decision theory
    • Stallard N. Sample size determination for phase II clinical trials based on Bayesian decision theory. Biometrics 1998; 54:279-294.
    • (1998) Biometrics , vol.54 , pp. 279-294
    • Stallard, N.1
  • 17
    • 33748521268 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts
    • Bretz F, Schmidli H, König F, Racine A, Maurer W. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: general concepts. Biometrical Journal 2006; 48:623-634.
    • (2006) Biometrical Journal , vol.48 , pp. 623-634
    • Bretz, F.1    Schmidli, H.2    König, F.3    Racine, A.4    Maurer, W.5
  • 18
    • 33748533820 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations
    • Schmidli H, Bretz F, Racine A, Maurer W. Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: applications and practical considerations. Biometrical Journal 2006; 48:635-643.
    • (2006) Biometrical Journal , vol.48 , pp. 635-643
    • Schmidli, H.1    Bretz, F.2    Racine, A.3    Maurer, W.4
  • 19
    • 84555178552 scopus 로고    scopus 로고
    • Seamless phase II/III designs
    • DOI: 10.1177/0962280210379035 [Available online ahead of print].
    • Stallard N, Todd S. Seamless phase II/III designs. Statistical Methods in Medical Research. DOI: 10.1177/0962280210379035 [Available online ahead of print].
    • Statistical Methods in Medical Research
    • Stallard, N.1    Todd, S.2
  • 21
    • 29544433886 scopus 로고    scopus 로고
    • Sample size of 12 per group rule of thumb for a pilot study
    • Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 2005; 4:287-291.
    • (2005) Pharmaceutical Statistics , vol.4 , pp. 287-291
    • Julious, S.A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.