메뉴 건너뛰기




Volumn 61, Issue 4, 2012, Pages 601-618

Blinded continuous monitoring of nuisance parameters in clinical trials

Author keywords

Clinical trials; Continuous monitoring; Sample size re estimation; Sequential designs

Indexed keywords


EID: 84864078220     PISSN: 00359254     EISSN: 14679876     Source Type: Journal    
DOI: 10.1111/j.1467-9876.2011.01029.x     Document Type: Article
Times cited : (17)

References (36)
  • 2
    • 78249260148 scopus 로고    scopus 로고
    • Aspects of modernizing drug development using clinical scenario planning and evaluation
    • Benda, N., Branson, M., Maurer, W. and Friede, T. (2010) Aspects of modernizing drug development using clinical scenario planning and evaluation. Drug Inform. J., 44, 299-315.
    • (2010) Drug Inform. J. , vol.44 , pp. 299-315
    • Benda, N.1    Branson, M.2    Maurer, W.3    Friede, T.4
  • 3
    • 0028595559 scopus 로고
    • Internal pilot studies for estimating sample size
    • Birkett, M. A. and Day, S. J. (1994) Internal pilot studies for estimating sample size. Statist. Med., 13, 2455-2463.
    • (1994) Statist. Med. , vol.13 , pp. 2455-2463
    • Birkett, M.A.1    Day, S.J.2
  • 4
    • 80052449334 scopus 로고    scopus 로고
    • Using real-time data to drive better decisions, faster
    • Brown Stafford, P. and Garrett, A. (2011) Using real-time data to drive better decisions, faster. Drug Inform. J., 45, 495-502.
    • (2011) Drug Inform. J. , vol.45 , pp. 495-502
    • Brown Stafford, P.1    Garrett, A.2
  • 5
    • 0001336620 scopus 로고
    • On the asymptotic theory of fixed width sequential confidence intervals for the mean
    • Chow, Y. S. and Robbins, H. (1965) On the asymptotic theory of fixed width sequential confidence intervals for the mean. Ann. Math. Statist., 36, 457-462.
    • (1965) Ann. Math. Statist. , vol.36 , pp. 457-462
    • Chow, Y.S.1    Robbins, H.2
  • 6
  • 7
    • 0033617687 scopus 로고    scopus 로고
    • Exact test size and power of a Gaussian error linear model for an internal pilot study
    • Coffey, C. S. and Muller, K. E. (1999) Exact test size and power of a Gaussian error linear model for an internal pilot study. Statist. Med., 18, 1199-1214.
    • (1999) Statist. Med. , vol.18 , pp. 1199-1214
    • Coffey, C.S.1    Muller, K.E.2
  • 8
    • 84864088853 scopus 로고    scopus 로고
    • Committee for Medicinal Products for Human Use Report CHMP/EWP/2459/02. European Medicines Agency, London. (Available from.)
    • Committee for Medicinal Products for Human Use (2007). Report CHMP/EWP/2459/02. European Medicines Agency, London. (Available from.)
    • (2007)
  • 9
    • 0034686811 scopus 로고    scopus 로고
    • Blinding in clinical trials and other studies
    • Day, S. J. and Altman, D. G. (2000) Blinding in clinical trials and other studies. Br. Med. J., 321, 504.
    • (2000) Br. Med. J. , vol.321 , pp. 504
    • Day, S.J.1    Altman, D.G.2
  • 10
    • 0033565742 scopus 로고    scopus 로고
    • Estimating the sample size for a t test using an internal pilot
    • Denne, J. S. and Jennison, C. (1999) Estimating the sample size for a t test using an internal pilot. Statist. Med., 18, 1575-1585.
    • (1999) Statist. Med. , vol.18 , pp. 1575-1585
    • Denne, J.S.1    Jennison, C.2
  • 11
    • 0003101751 scopus 로고    scopus 로고
    • A group sequential t-test with updating of sample size
    • Denne, J. S. and Jennison, C. (2000) A group sequential t-test with updating of sample size. Biometrika, 87, 125-134.
    • (2000) Biometrika , vol.87 , pp. 125-134
    • Denne, J.S.1    Jennison, C.2
  • 12
    • 0040235596 scopus 로고
    • An improved method for deriving optimal one-sided group sequential tests
    • Eales, J. D. and Jennison, C. (1992) An improved method for deriving optimal one-sided group sequential tests. Biometrika, 79, 13-24.
    • (1992) Biometrika , vol.79 , pp. 13-24
    • Eales, J.D.1    Jennison, C.2
  • 14
    • 0035977436 scopus 로고    scopus 로고
    • A comparison of methods for adaptive sample size adjustment
    • Friede, T. and Kieser, M. (2001) A comparison of methods for adaptive sample size adjustment. Statist. Med., 20, 3861-3873.
    • (2001) Statist. Med. , vol.20 , pp. 3861-3873
    • Friede, T.1    Kieser, M.2
  • 15
    • 0037473240 scopus 로고    scopus 로고
    • Blinded sample size reassessment in non-inferiority and equivalence trials
    • Friede, T. and Kieser, M. (2003) Blinded sample size reassessment in non-inferiority and equivalence trials. Statist. Med., 22, 995-1007.
    • (2003) Statist. Med. , vol.22 , pp. 995-1007
    • Friede, T.1    Kieser, M.2
  • 16
    • 33748550685 scopus 로고    scopus 로고
    • Sample size recalculation in internal pilot study designs: a review
    • Friede, T. and Kieser, M. (2006) Sample size recalculation in internal pilot study designs: a review. Biometr. J., 48, 537-555.
    • (2006) Biometr. J. , vol.48 , pp. 537-555
    • Friede, T.1    Kieser, M.2
  • 18
    • 36248956729 scopus 로고    scopus 로고
    • Adaptive seamless designs: selection and prospective testing of hypotheses
    • Jennison, C. and Turnbull, B. W. (2007) Adaptive seamless designs: selection and prospective testing of hypotheses. J. Biopharm. Statist., 17, 1135-1161.
    • (2007) J. Biopharm. Statist. , vol.17 , pp. 1135-1161
    • Jennison, C.1    Turnbull, B.W.2
  • 19
    • 0034656288 scopus 로고    scopus 로고
    • Recalculating the sample size in internal pilot study designs with control of the type I error rate
    • Kieser, M. and Friede, T. (2000) Recalculating the sample size in internal pilot study designs with control of the type I error rate. Statist. Med., 19, 901-911.
    • (2000) Statist. Med. , vol.19 , pp. 901-911
    • Kieser, M.1    Friede, T.2
  • 20
    • 0345329168 scopus 로고    scopus 로고
    • Simple procedures for blinded sample size adjustment that do not affect the type I error rate
    • Kieser, M. and Friede, T. (2003) Simple procedures for blinded sample size adjustment that do not affect the type I error rate. Statist. Med., 22, 3571-3581.
    • (2003) Statist. Med. , vol.22 , pp. 3571-3581
    • Kieser, M.1    Friede, T.2
  • 21
    • 0242694372 scopus 로고    scopus 로고
    • Acute stroke therapy by inhibition of neutrophils (ASTIN): an adaptive dose-response study of UK-279,276 in acute ischemic stroke
    • and for the ASTIN Study Investigators
    • Krams, M., Lees, K. R., Hacke, W., Grieve, A. P., Orgogozo, J. M. and Ford, G. A. for the ASTIN Study Investigators (2003) Acute stroke therapy by inhibition of neutrophils (ASTIN): an adaptive dose-response study of UK-279, 276 in acute ischemic stroke. Stroke, 34, 2543-2548.
    • (2003) Stroke , vol.34 , pp. 2543-2548
    • Krams, M.1    Lees, K.R.2    Hacke, W.3    Grieve, A.P.4    Orgogozo, J.M.5    Ford, G.A.6
  • 22
    • 51549094845 scopus 로고    scopus 로고
    • Effect on blood pressure of lumiracoxib versus ibuprofen in patients with osteoarthritis and controlled hypertension: a randomized trial
    • MacDonald, T. M., Reginster, J.-Y., Littlejohn, T. W., Richard, D., Lheritier, K., Krammer, G. and Rebuli, R. (2008) Effect on blood pressure of lumiracoxib versus ibuprofen in patients with osteoarthritis and controlled hypertension: a randomized trial. J. Hypertensn, 26, 1695-1704.
    • (2008) J. Hypertensn , vol.26 , pp. 1695-1704
    • MacDonald, T.M.1    Reginster, J.-Y.2    Littlejohn, T.W.3    Richard, D.4    Lheritier, K.5    Krammer, G.6    Rebuli, R.7
  • 23
    • 0035739842 scopus 로고    scopus 로고
    • Flexible sample size considerations using information-based interim monitoring
    • Mehta, C. R. and Tsiatis, A. A. (2001) Flexible sample size considerations using information-based interim monitoring. Drug Inform. J., 35, 1095-1112.
    • (2001) Drug Inform. J. , vol.35 , pp. 1095-1112
    • Mehta, C.R.1    Tsiatis, A.A.2
  • 24
    • 20744453354 scopus 로고    scopus 로고
    • Variance estimation in clinical studies with interim sample size reestimation
    • Miller, F. (2005) Variance estimation in clinical studies with interim sample size reestimation. Biometrics, 61, 355-361.
    • (2005) Biometrics , vol.61 , pp. 355-361
    • Miller, F.1
  • 25
    • 33644914207 scopus 로고    scopus 로고
    • Adaptive designs for pivotal trials: discussion points from the PSI Adaptive Design Expert Group
    • Phillips, A. J. and Keene, O. N. (2006) Adaptive designs for pivotal trials: discussion points from the PSI Adaptive Design Expert Group. Pharm. Statist., 5, 61-66.
    • (2006) Pharm. Statist. , vol.5 , pp. 61-66
    • Phillips, A.J.1    Keene, O.N.2
  • 26
    • 66349091397 scopus 로고    scopus 로고
    • Sample size re-estimation in clinical trials
    • Proschan, M. (2009) Sample size re-estimation in clinical trials. Biometr. J., 51, 348-357.
    • (2009) Biometr. J. , vol.51 , pp. 348-357
    • Proschan, M.1
  • 27
    • 0037160763 scopus 로고    scopus 로고
    • Blinding in randomised trials: hiding who got what
    • Schulz, K. F. and Grimes, D. A. (2002) Blinding in randomised trials: hiding who got what. Lancet, 359, 696-700.
    • (2002) Lancet , vol.359 , pp. 696-700
    • Schulz, K.F.1    Grimes, D.A.2
  • 29
    • 19944432721 scopus 로고    scopus 로고
    • The effects of cyclooxygenase-2 inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in patients with hypertension, osteoarthritis, and type 2 Diabetes Mellitus
    • and for the Celecoxib Rofecoxib Efficacy and Safety in Comorbidities Evaluation Trial (CRESCENT) Investigators
    • Sowers, J. R., White, W. B., Pitt, B., Whelton, A., Simon, L. S., Winer, N., Kivitz, A., van Ingen, H., Brabant, T. and Fort, J. G. for the Celecoxib Rofecoxib Efficacy and Safety in Comorbidities Evaluation Trial (CRESCENT) Investigators (2005) The effects of cyclooxygenase-2 inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in patients with hypertension, osteoarthritis, and type 2 Diabetes Mellitus. Arch. Intern. Med., 165, 161-168.
    • (2005) Arch. Intern. Med. , vol.165 , pp. 161-168
    • Sowers, J.R.1    White, W.B.2    Pitt, B.3    Whelton, A.4    Simon, L.S.5    Winer, N.6    Kivitz, A.7    van Ingen, H.8    Brabant, T.9    Fort, J.G.10
  • 30
    • 0002815335 scopus 로고
    • The performance of a sequential procedure for the fixed width interval estimation of the mean
    • Starr, N. (1966) The performance of a sequential procedure for the fixed width interval estimation of the mean. Ann. Math. Statist., 37, 36-50.
    • (1966) Ann. Math. Statist. , vol.37 , pp. 36-50
    • Starr, N.1
  • 31
    • 0000537133 scopus 로고
    • A two-sample test for a linear hypothesis whose power is independent of the variance
    • Stein, C. (1945) A two-sample test for a linear hypothesis whose power is independent of the variance. Ann. Math. Statist., 16, 243-258.
    • (1945) Ann. Math. Statist. , vol.16 , pp. 243-258
    • Stein, C.1
  • 32
    • 34548764401 scopus 로고    scopus 로고
    • Real-time data collection for pain: appraisal and current status
    • Stone, A. and Broderick, J. E. (2007) Real-time data collection for pain: appraisal and current status. Pain Med., 8, suppl., S85-S93.
    • (2007) Pain Med. , vol.8 , Issue.SUPPL.
    • Stone, A.1    Broderick, J.E.2
  • 33
    • 33749322274 scopus 로고    scopus 로고
    • Information-based monitoring of clinical trials
    • Tsiatis, A. A. (2006) Information-based monitoring of clinical trials. Statist. Med., 25, 3236-3244.
    • (2006) Statist. Med. , vol.25 , pp. 3236-3244
    • Tsiatis, A.A.1
  • 34
    • 0036237083 scopus 로고    scopus 로고
    • Effects of celecoxib on ambulatory blood pressure in hypertensive patients on ACE inhibitors
    • White, W. B., Kent, J., Taylor, A., Verburg, K. M., Lefkowith, J. B. and Whelton, A. (2002) Effects of celecoxib on ambulatory blood pressure in hypertensive patients on ACE inhibitors. Hypertension, 39, 929-934.
    • (2002) Hypertension , vol.39 , pp. 929-934
    • White, W.B.1    Kent, J.2    Taylor, A.3    Verburg, K.M.4    Lefkowith, J.B.5    Whelton, A.6
  • 35
    • 84864088631 scopus 로고
    • The role of internal pilot studies in increasing the efficiency of clinical trials
    • Wittes, J. and Brittain, E. (1990) The role of internal pilot studies in increasing the efficiency of clinical trials. Statist. Med., 18, 3493-3509.
    • (1990) Statist. Med. , vol.18 , pp. 3493-3509
    • Wittes, J.1    Brittain, E.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.