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Volumn 107, Issue 6, 2012, Pages 910-917

Stopping clinical trials early for futility: Retrospective analysis of several randomised clinical studies

Author keywords

clinical trials; conditional power; early stopping; futility analysis

Indexed keywords

ANALYTIC METHOD; ARTICLE; CALCULATION; COST CONTROL; DRUG TREATMENT FAILURE; FUTILITY ANALYSIS; HUMAN; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; TREATMENT OUTCOME;

EID: 84865863356     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2012.344     Document Type: Article
Times cited : (37)

References (27)
  • 1
    • 65649092645 scopus 로고    scopus 로고
    • How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design-a reanalysis of 4 trials
    • Barthel FM, Parmar MK, Royston P (2009) How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design-a reanalysis of 4 trials. Trials 10: 1-10
    • (2009) Trials , vol.10 , pp. 1-10
    • Barthel, F.M.1    Parmar, M.K.2    Royston, P.3
  • 2
    • 33745308514 scopus 로고    scopus 로고
    • Adjuvant goserelin in pre-menopausal patients with early breast cancer: Results from the ZIPP study
    • ZIPP International Collaborators Group
    • Baum M, Hackshaw A, Houghton J, Rutqvist, Fornander T, Nordenskjold B, Nicolucci A, Sainsbury R, ZIPP International Collaborators Group (2006) Adjuvant goserelin in pre-menopausal patients with early breast cancer: Results from the ZIPP study. Eur J Cancer 42(7): 895-904
    • (2006) Eur J Cancer , vol.42 , Issue.7 , pp. 895-904
    • Baum, M.1    Hackshaw, A.2    Houghton, J.3    Rutqvist Fornander, T.4    Nordenskjold, B.5    Nicolucci, A.6    Sainsbury, R.7
  • 3
    • 49749131610 scopus 로고    scopus 로고
    • Futility approaches to interim monitoring by data monitoring committees
    • DeMets DL (2006) Futility approaches to interim monitoring by data monitoring committees. Clin Trials 3: 522-529
    • (2006) Clin Trials , vol.3 , pp. 522-529
    • Demets, D.L.1
  • 5
    • 77952760568 scopus 로고    scopus 로고
    • A general inefficacy interim monitoring rule for randomized clinical trials
    • Freidlin B, Korn EL, Gray R (2010) A general inefficacy interim monitoring rule for randomized clinical trials. Clin Trials 7: 197-208
    • (2010) Clin Trials , vol.7 , pp. 197-208
    • Freidlin, B.1    Korn, E.L.2    Gray, R.3
  • 6
    • 79955602736 scopus 로고    scopus 로고
    • Long-term benefits of 5 years of tamoxifen: 10 year follow up of a large randomised trial in women aged at least 50 years with early breast cancer
    • Hackshaw A, Roughton M, Forsyth S, Monson K, Reczko K, Sainsbury R, Baum M (2011) Long-term benefits of 5 years of tamoxifen: 10 year follow up of a large randomised trial in women aged at least 50 years with early breast cancer. J Clin Oncol 29(13): 1657-1663
    • (2011) J Clin Oncol , vol.29 , Issue.13 , pp. 1657-1663
    • Hackshaw, A.1    Roughton, M.2    Forsyth, S.3    Monson, K.4    Reczko, K.5    Sainsbury, R.6    Baum, M.7
  • 8
    • 84865860804 scopus 로고    scopus 로고
    • On stopping a randomized clinical trial for futility
    • Harrington D (ed) (Applied Bioinformatics and Biostatistics in Cancer Research) Springer: USA
    • Herson J, Buyse M, Wittes JT (2011) On Stopping a Randomized Clinical Trial for Futility. In Designs for Clinical Trials: Perspectives on Current Issues, Harrington D (ed) (Applied Bioinformatics and Biostatistics in Cancer Research) Springer: USA
    • (2011) Designs for Clinical Trials: Perspectives on Current Issues
    • Herson, J.1    Buyse, M.2    Wittes, J.T.3
  • 9
    • 65649083667 scopus 로고    scopus 로고
    • Informing the selection of futility stopping thresholds: Case study from a late-phase clinical trial
    • Hughes S, Cuffe RL, Lieftucht A, Garrett Nichols W (2009) Informing the selection of futility stopping thresholds: case study from a late-phase clinical trial. Pharm Stat 8(1): 25-37
    • (2009) Pharm Stat , vol.8 , Issue.1 , pp. 25-37
    • Hughes, S.1    Cuffe, R.L.2    Lieftucht, A.3    Garrett Nichols, W.4
  • 10
    • 77149150913 scopus 로고    scopus 로고
    • Futility interim monitoring with control of type i and II error probabilities using the interim Z-value or confidence limit
    • Lachin JM (2009) Futility interim monitoring with control of type I and II error probabilities using the interim Z-value or confidence limit. Clin Trials 6: 565-573
    • (2009) Clin Trials , vol.6 , pp. 565-573
    • Lachin, J.M.1
  • 11
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan KKG, DeMets DL (1983) Discrete sequential boundaries for clinical trials. Biometrika 70: 659-663
    • (1983) Biometrika , vol.70 , pp. 659-663
    • Kkg, L.1    Demets, D.L.2
  • 12
    • 84953030627 scopus 로고
    • Stochastically curtailed tests in long-term clinical trials
    • Lan KKG, Simon R, Halperin M (1982) Stochastically curtailed tests in long-term clinical trials. Commun Stat C1: 207-219
    • (1982) Commun Stat , vol.C1 , pp. 207-219
    • Kkg, L.1    Simon, R.2    Halperin, M.3
  • 13
    • 0023677293 scopus 로고
    • The B-value: A tool for monitoring data
    • Lan KKG, Wittes J (1988) The B-value: a tool for monitoring data. Biometrics 44: 579-585
    • (1988) Biometrics , vol.44 , pp. 579-585
    • Kkg, L.1    Wittes, J.2
  • 14
    • 68249146507 scopus 로고    scopus 로고
    • Anti-angiogenic therapy using thalidomide combined with chemotherapy in small cell lung cancer: A randomized, double-blind, placebo-controlled trial
    • Lee SM, Woll PJ, Rudd R, Ferry D, O'Brien M, Middleton G, Spiro S, James L, Ali K, Jitlal M, Hackshaw A (2009a) Anti-angiogenic therapy using thalidomide combined with chemotherapy in small cell lung cancer: a randomized, double-blind, placebo-controlled trial. J Natl Cancer Inst 101(15): 1049-1057
    • (2009) J Natl Cancer Inst , vol.101 , Issue.15 , pp. 1049-1057
    • Lee, S.M.1    Woll, P.J.2    Rudd, R.3    Ferry, D.4    O'Brien, M.5    Middleton, G.6    Spiro, S.7    James, L.8    Ali, K.9    Jitlal, M.10    Hackshaw, A.11
  • 15
    • 70449720894 scopus 로고    scopus 로고
    • Randomized double-blind placebo-controlled trial of thalidomide in combination with gemcitabine and Carboplatin in advanced non-small-cell lung cancer
    • Lee SM, Rudd R, Woll PJ, Ottensmeier C, Gilligan D, Price A, Spiro S, Gower N, Jitlal M, Hackshaw A (2009b) Randomized double-blind placebo-controlled trial of thalidomide in combination with gemcitabine and Carboplatin in advanced non-small-cell lung cancer. J Clin Oncol 27(31): 5248-5254
    • (2009) J Clin Oncol , vol.27 , Issue.31 , pp. 5248-5254
    • Lee, S.M.1    Rudd, R.2    Woll, P.J.3    Ottensmeier, C.4    Gilligan, D.5    Price, A.6    Spiro, S.7    Gower, N.8    Jitlal, M.9    Hackshaw, A.10
  • 16
    • 78651104046 scopus 로고    scopus 로고
    • TOPICAL: Randomized phase III trial of erlotinib compared with placebo in chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) and unsuitable for first-line chemotherapy
    • abstr 7504
    • Lee S, Rudd R, Khan I, Upadhyay S, Lewanski CR, Falk S, Skailes G, Partridge R, Ngai Y, Boshoff C (2010) TOPICAL: Randomized phase III trial of erlotinib compared with placebo in chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) and unsuitable for first-line chemotherapy. J Clin Oncol 28(15s suppl): abstr 7504
    • (2010) J Clin Oncol , vol.28 , Issue.15 SUPPL. S
    • Lee, S.1    Rudd, R.2    Khan, I.3    Upadhyay, S.4    Lewanski, C.R.5    Falk, S.6    Skailes, G.7    Partridge, R.8    Ngai, Y.9    Boshoff, C.10
  • 17
    • 77950347260 scopus 로고    scopus 로고
    • Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I)
    • Northover J, Glynne-Jones R, Sebag-Montefiore D, James R, Meadows H, Wan S, Jitlal M, Ledermann J (2010) Chemoradiation for the treatment of epidermoid anal cancer: 13-year follow-up of the first randomised UKCCCR Anal Cancer Trial (ACT I). Br J Cancer 102(7): 1123-1128
    • (2010) Br J Cancer , vol.102 , Issue.7 , pp. 1123-1128
    • Northover, J.1    Glynne-Jones, R.2    Sebag-Montefiore, D.3    James, R.4    Meadows, H.5    Wan, S.6    Jitlal, M.7    Ledermann, J.8
  • 18
    • 36849062123 scopus 로고    scopus 로고
    • Current controversies in data monitoring for clinical trials
    • Pocock SJ (2006) Current controversies in data monitoring for clinical trials. Clin Trials 3: 513-521
    • (2006) Clin Trials , vol.3 , pp. 513-521
    • Pocock, S.J.1
  • 20
    • 0043172579 scopus 로고    scopus 로고
    • Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer
    • Royston P, Mahesh KB, Qian W (2003) Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer. Stat Med 22: 2239-2256
    • (2003) Stat Med , vol.22 , pp. 2239-2256
    • Royston, P.1    Mahesh, K.B.2    Qian, W.3
  • 23
    • 33748445905 scopus 로고    scopus 로고
    • Early compared with late radiotherapy in combined modality treatment for limited disease small-cell lung cancer: A London Lung Cancer Group multicenter randomized clinical trial and meta-analysis
    • London Lung Cancer Group
    • Spiro SG, James LE, Rudd RM, Trask CW, Tobias JS, Snee M, Gilligan D, Murray PA, Ruiz de Elvira MC, O'Donnell KM, Gower NH, Harper PG, Hackshaw AK, London Lung Cancer Group (2006) Early compared with late radiotherapy in combined modality treatment for limited disease small-cell lung cancer: a London Lung Cancer Group multicenter randomized clinical trial and meta-analysis. J Clin Oncol 24(24): 3823-3830
    • (2006) J Clin Oncol , vol.24 , Issue.24 , pp. 3823-3830
    • Spiro, S.G.1    James, L.E.2    Rudd, R.M.3    Trask, C.W.4    Tobias, J.S.5    Snee, M.6    Gilligan, D.7    Murray, P.A.8    Ruiz De Elvira, M.C.9    O'Donnell, K.M.10    Gower, N.H.11    Harper, P.G.12    Hackshaw, A.K.13
  • 24
    • 73249127003 scopus 로고    scopus 로고
    • Chemoradiotherapy for locally advanced head and neck cancer: 10-year follow-up of the UK Head and Neck (UKHAN1) trial
    • UK Head and Neck Cancer Trialists' Group
    • Tobias JS, Monson K, Gupta N, Macdougall H, Glaholm J, Hutchison I, Kadalayil L, Hackshaw A, UK Head and Neck Cancer Trialists' Group (2010) Chemoradiotherapy for locally advanced head and neck cancer: 10-year follow-up of the UK Head and Neck (UKHAN1) trial. Lancet Oncol 11(1): 66-74
    • (2010) Lancet Oncol , vol.11 , Issue.1 , pp. 66-74
    • Tobias, J.S.1    Monson, K.2    Gupta, N.3    MacDougall, H.4    Glaholm, J.5    Hutchison, I.6    Kadalayil, L.7    Hackshaw, A.8
  • 25
    • 0000278788 scopus 로고    scopus 로고
    • Epidermoid anal cancer: Results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin
    • UKCCCR Anal Cancer Trial Working Party
    • UKCCCR Anal Cancer Trial Working Party (1996) Epidermoid anal cancer: Results from the UKCCCR randomised trial of radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. Lancet 348: 1049-1054
    • (1996) Lancet , vol.348 , pp. 1049-1054
  • 27
    • 0037445425 scopus 로고    scopus 로고
    • Stopping clinical trials because of treatment ineffectiveness: A comparison of a futility design with a method of stochastic curtailment
    • Whitehead J, Matsushita T (2003) Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment. Statistics in Medicine 22(5): 677-687
    • (2003) Statistics in Medicine , vol.22 , Issue.5 , pp. 677-687
    • Whitehead, J.1    Matsushita, T.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.