메뉴 건너뛰기




Volumn 40, Issue 4, 2006, Pages 463-473

Adaptive seamless phase II/III designs - Background, operational aspects, and examples

Author keywords

Adaptive designs; Seamless designs

Indexed keywords

BAYES THEOREM; CLINICAL RESEARCH; CLINICAL STUDY; CONFIDENCE INTERVAL; PRIORITY JOURNAL; REVIEW; STANDARD; STATISTICAL MODEL; STATISTICAL PARAMETERS;

EID: 33750854113     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/216847900604000412     Document Type: Review
Times cited : (107)

References (28)
  • 1
    • 33750854903 scopus 로고    scopus 로고
    • Adaptive designs: Terminology and classification
    • Dragalin V. Adaptive designs: terminology and classification. Drug Inf J. 2006;40:425-436.
    • (2006) Drug Inf J , vol.40 , pp. 425-436
    • Dragalin, V.1
  • 2
    • 33750893179 scopus 로고    scopus 로고
    • Implementing adaptive designs: Logistical and operational considerations
    • Quinlan JA, Krams M. Implementing adaptive designs: logistical and operational considerations. Drug Inf J. 2006;40:437-444.
    • (2006) Drug Inf J , vol.40 , pp. 437-444
    • Quinlan, J.A.1    Krams, M.2
  • 4
    • 0000145493 scopus 로고
    • A selection procedure for selecting the population with the largest mean from k normal populations
    • Paulson E. A selection procedure for selecting the population with the largest mean from k normal populations. Ann Math Stat. 1964;35:174-180.
    • (1964) Ann Math Stat , vol.35 , pp. 174-180
    • Paulson, E.1
  • 5
    • 0024381579 scopus 로고
    • A two-stage design for choosing among several experimental treatments and a control in clinical trials
    • Thall PF, Simon R, Ellenberg SS. A two-stage design for choosing among several experimental treatments and a control in clinical trials. Biometrics. 1989;45:537-547.
    • (1989) Biometrics , vol.45 , pp. 537-547
    • Thall, P.F.1    Simon, R.2    Ellenberg, S.S.3
  • 6
    • 0000623392 scopus 로고
    • Optimal two stage screening designs for survival comparisons
    • Schaid DJ, Wieand S, Therneau TM. Optimal two stage screening designs for survival comparisons. Biometrika. 1990;77:659-663.
    • (1990) Biometrika , vol.77 , pp. 659-663
    • Schaid, D.J.1    Wieand, S.2    Therneau, T.M.3
  • 7
    • 0037445466 scopus 로고    scopus 로고
    • Sequential designs for phase III clinical trials incorporating treatment selection
    • Stallard N, Todd S. Sequential designs for phase III clinical trials incorporating treatment selection. Stat Med. 2003;22:689-703.
    • (2003) Stat Med , vol.22 , pp. 689-703
    • Stallard, N.1    Todd, S.2
  • 8
    • 0028247382 scopus 로고
    • Monitoring pairwise comparisons in multi-armed clinical trials
    • Follman DA, Proschan MA, Geller NL. Monitoring pairwise comparisons in multi-armed clinical trials. Biometrics 1994;50:325-336.
    • (1994) Biometrics , vol.50 , pp. 325-336
    • Follman, D.A.1    Proschan, M.A.2    Geller, N.L.3
  • 9
    • 0034870726 scopus 로고    scopus 로고
    • Monitoring clinical trials with multiple arms
    • Hellmich M. Monitoring clinical trials with multiple arms. Biometrics. 2001;57:892-898.
    • (2001) Biometrics , vol.57 , pp. 892-898
    • Hellmich, M.1
  • 10
    • 15844387277 scopus 로고    scopus 로고
    • Adaptive two-stage test procedures to find the best treatment in clinical trials
    • Bischoff W, Miller F. Adaptive two-stage test procedures to find the best treatment in clinical trials. Biometrika. 2005;92:197-212.
    • (2005) Biometrika , vol.92 , pp. 197-212
    • Bischoff, W.1    Miller, F.2
  • 11
    • 18444411392 scopus 로고    scopus 로고
    • A new clinical trial design combining phases II and III: Sequential designs with treatment selection and a change of endpoint
    • Todd S, Stallard N. A new clinical trial design combining phases II and III: sequential designs with treatment selection and a change of endpoint. Drug Inf J. 2005;39:109-118.
    • (2005) Drug Inf J , vol.39 , pp. 109-118
    • Todd, S.1    Stallard, N.2
  • 12
    • 0028619850 scopus 로고
    • Evaluation of experiments with adaptive interim analyses
    • Bauer P, Köhne K. Evaluation of experiments with adaptive interim analyses. Biometrics. 1994;50: 1029-1041.
    • (1994) Biometrics , vol.50 , pp. 1029-1041
    • Bauer, P.1    Köhne, K.2
  • 13
    • 0033618626 scopus 로고    scopus 로고
    • Combining different phases in the development of medical treatments within a single trial
    • Bauer P, Kieser M. Combining different phases in the development of medical treatments within a single trial. Stat Med. 1999;18:1833-1848.
    • (1999) Stat Med , vol.18 , pp. 1833-1848
    • Bauer, P.1    Kieser, M.2
  • 15
    • 0034876356 scopus 로고    scopus 로고
    • Adaptive group sequential designs for clinical trials: Combining the advantages of adaptive and classical group sequential approaches
    • Müller HH, Schäfer H. Adaptive group sequential designs for clinical trials: combining the advantages of adaptive and classical group sequential approaches. Biometrics. 2001;57:886-819.
    • (2001) Biometrics , vol.57 , pp. 886-1819
    • Müller, H.H.1    Schäfer, H.2
  • 16
    • 20444434001 scopus 로고    scopus 로고
    • Phase II and III combination designs to accelerate drug development
    • Liu Q, Pledger GW. Phase II and III combination designs to accelerate drug development. J Am Stat Assoc. 2005;100:493-502.
    • (2005) J Am Stat Assoc , vol.100 , pp. 493-502
    • Liu, Q.1    Pledger, G.W.2
  • 17
    • 30944469129 scopus 로고    scopus 로고
    • Testing and estimation in flexible group sequential designs with adaptive treatment selection
    • Posch M, Koenig F, Brannath W, Dunger-Baldauf C, Bauer P. Testing and estimation in flexible group sequential designs with adaptive treatment selection. Stat Med. 2005;24:3697-3714.
    • (2005) Stat Med , vol.24 , pp. 3697-3714
    • Posch, M.1    Koenig, F.2    Brannath, W.3    Dunger-Baldauf, C.4    Bauer, P.5
  • 18
    • 33646257465 scopus 로고    scopus 로고
    • Application of adaptive designs - A review
    • Bauer P, Einfalt J. Application of adaptive designs-a review. Biometrical J. 2006;48:14.
    • (2006) Biometrical J , vol.48 , pp. 14
    • Bauer, P.1    Einfalt, J.2
  • 19
    • 22044437813 scopus 로고    scopus 로고
    • An adaptive group sequential design for phase II/III clinical trials that select a single treatment from several
    • Kelly PJ, Stallard N, Todd S. An adaptive group sequential design for phase II/III clinical trials that select a single treatment from several. J Biopharm Stat. 2005;15:641-658.
    • (2005) J Biopharm Stat , vol.15 , pp. 641-658
    • Kelly, P.J.1    Stallard, N.2    Todd, S.3
  • 20
    • 0036968867 scopus 로고    scopus 로고
    • Seamlessly expanding a randomized phase II trial to phase III
    • Inoue LYT, Thall PF, Berry DA. Seamlessly expanding a randomized phase II trial to phase III. Biometrics. 2002;58:823-831.
    • (2002) Biometrics , vol.58 , pp. 823-831
    • Inoue, L.Y.T.1    Thall, P.F.2    Berry, D.A.3
  • 22
    • 27744573697 scopus 로고    scopus 로고
    • Combining multiple comparisons and modeling techniques in dose response studies
    • Bretz F, Pinheiro JC, Branson M. Combining multiple comparisons and modeling techniques in dose response studies. Biometrics. 2005;61:738-748.
    • (2005) Biometrics , vol.61 , pp. 738-748
    • Bretz, F.1    Pinheiro, J.C.2    Branson, M.3
  • 23
    • 0141883605 scopus 로고    scopus 로고
    • Sample size reassessment in adaptive clinical trials using a bias corrected estimate
    • Coburger S, Wassmer G. Sample size reassessment in adaptive clinical trials using a bias corrected estimate. Biometrical J. 2003;45:812-825.
    • (2003) Biometrical J , vol.45 , pp. 812-825
    • Coburger, S.1    Wassmer, G.2
  • 24
    • 0038739457 scopus 로고    scopus 로고
    • Improved repeated confidence bounds in trials with a maximal goal
    • Brannath W, König F, Bauer P. Improved repeated confidence bounds in trials with a maximal goal. Biometrical J. 2003;45:311-324.
    • (2003) Biometrical J , vol.45 , pp. 311-324
    • Brannath, W.1    König, F.2    Bauer, P.3
  • 25
    • 22144453601 scopus 로고    scopus 로고
    • Drop-the-losers design: Normal case
    • Sampson AR, Sill MW. Drop-the-losers design: normal case. Biometrical J. 2005;47:257-281.
    • (2005) Biometrical J , vol.47 , pp. 257-281
    • Sampson, A.R.1    Sill, M.W.2
  • 26
    • 18444383925 scopus 로고    scopus 로고
    • Point estimates and confidence regions for sequential trials involving selection
    • Stallard N, Todd S. Point estimates and confidence regions for sequential trials involving selection. J. Statist Plan Inference. 2005;135:402-419.
    • (2005) J Statist Plan Inference , vol.135 , pp. 402-419
    • Stallard, N.1    Todd, S.2
  • 27
    • 34748860155 scopus 로고    scopus 로고
    • Establishment and Operation of Clinical Trial Data Monitoring Committees. Rockville MD: FDA. Available at. Accessed August 15, 2006
    • US Food and Drug Administration. Guidance for Clinical Trial Sponsors. Establishment and Operation of Clinical Trial Data Monitoring Committees. Rockville MD: FDA; 2006. Available at: http://www.fda.gov/cber/gdlns/clindatmon. htm. Accessed August 15, 2006.
    • (2006) Guidance for Clinical Trial Sponsors


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.