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Volumn , Issue , 2014, Pages 289-319

Detecting safety signals in subgroups

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EID: 85041305764     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1201/b17846     Document Type: Chapter
Times cited : (5)

References (58)
  • 1
    • 40749105725 scopus 로고    scopus 로고
    • Graphical approaches to the analysis of safety data from clinical trials
    • Amit O, Heiberger RM, Lane PW. Graphical approaches to the analysis of safety data from clinical trials. Pharmaceutical Statistics, 7: 20-35, 2008.
    • (2008) Pharmaceutical Statistics , vol.7 , pp. 20-35
    • Amit, O.1    Heiberger, R.M.2    Lane, P.W.3
  • 2
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis) uses of baseline data in clinical trials
    • Assmann, SF, Pocock SJ, Enos LE, Kasten LE. Subgroup analysis and other (mis) uses of baseline data in clinical trials. Lancet, 355: 1064-1069, 2000.
    • (2000) Lancet , vol.355 , pp. 1064-1069
    • Assmann, S.F.1    Pocock, S.J.2    Enos, L.E.3    Kasten, L.E.4
  • 3
    • 38749084883 scopus 로고    scopus 로고
    • High prevalence of drug-induced pneumonia in Japan
    • Azuma A, Kudoh S, High prevalence of drug-induced pneumonia in Japan. Japan Medical Association Journal, 50(5): 405-411, 2007.
    • (2007) Japan Medical Association Journal , vol.50 , Issue.5 , pp. 405-411
    • Azuma, A.1    Kudoh, S.2
  • 5
    • 77950481806 scopus 로고    scopus 로고
    • The FDA and safe use of long-acting beta-agonists in the treatment of asthma
    • Chowdhury BA, Dal Pan G. The FDA and safe use of long-acting beta-agonists in the treatment of asthma. The New England Journal of Medicine, 362(13): 1169-1171, 2010.
    • (2010) The New England Journal of Medicine , vol.362 , Issue.13 , pp. 1169-1171
    • Chowdhury, B.A.1    Dal Pan, G.2
  • 6
    • 79551566730 scopus 로고    scopus 로고
    • Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies
    • Chuang-Stein C, Beltangady M. Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies. Pharmaceutical Statistics, 10(1): 3-7, 2011.
    • (2011) Pharmaceutical Statistics , vol.10 , Issue.1 , pp. 3-7
    • Chuang-Stein, C.1    Beltangady, M.2
  • 7
    • 84873297083 scopus 로고    scopus 로고
    • The practice of pre-marketing safety assessment in drug development
    • Chuang-Stein C, Xia A. The practice of pre-marketing safety assessment in drug development. Journal of Biopharmaceutical Statistics, 23(1): 3-25, 2013.
    • (2013) Journal of Biopharmaceutical Statistics , vol.23 , Issue.1 , pp. 3-25
    • Chuang-Stein, C.1    Xia, A.2
  • 8
    • 0000642942 scopus 로고
    • Some methods for strengthening the common chi-square tests
    • Cochran WG. Some methods for strengthening the common chi-square tests. Biometrics, 10: 417-451, 1954.
    • (1954) Biometrics , vol.10 , pp. 417-451
    • Cochran, W.G.1
  • 9
    • 85054666232 scopus 로고
    • NIH Revitalization Act. Sec. 131, Inclusion of Women and Minorities in Clinical Research, 20 May
    • Congressional Record-House. NIH Revitalization Act. Sec. 131, Inclusion of Women and Minorities in Clinical Research, 20 May, page H2623, 1993.
    • (1993) , pp. H2623
  • 10
    • 71049122764 scopus 로고    scopus 로고
    • Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: A report of the safety planning, evaluation, and reporting team
    • Crowe BJ, Xia HA, Berlin JA, Watson DJ, Shi H, Lin SL, Kuebler J et al. Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: A report of the safety planning, evaluation, and reporting team. Clinical Trials, 6(5): 430-440, 2009.
    • (2009) Clinical Trials , vol.6 , Issue.5 , pp. 430-440
    • Crowe, B.J.1    Xia, H.A.2    Berlin, J.A.3    Watson, D.J.4    Shi, H.5    Lin, S.L.6    Kuebler, J.7
  • 12
    • 17044400164 scopus 로고    scopus 로고
    • Forest plots and the interpretation of subgroups
    • Cuzick J. Forest plots and the interpretation of subgroups. Lancet, 365: 1308, 2005.
    • (2005) Lancet , vol.365 , pp. 1308
    • Cuzick, J.1
  • 13
    • 0025256870 scopus 로고
    • Empirical Bayes estimates of subgroup effects in clinical trials
    • Davis CE, Leffingwell DP. Empirical Bayes estimates of subgroup effects in clinical trials. Controlled Clinical Trials, 11: 37-42, 1990.
    • (1990) Controlled Clinical Trials , vol.11 , pp. 37-42
    • Davis, C.E.1    Leffingwell, D.P.2
  • 16
    • 0028858130 scopus 로고
    • Interpretation of subgroup analyses in clinical trials
    • Fleming TR. Interpretation of subgroup analyses in clinical trials. Drug Information Journal, 29: 1681S-1687S, 1995.
    • (1995) Drug Information Journal , vol.29 , pp. 1681-1687
    • Fleming, T.R.1
  • 17
    • 27544454016 scopus 로고    scopus 로고
    • Accessed January 10, 2014
    • Food and Drug Administration. Guidance for industry-Premarketing risk assessment. http://www.fda.gov/downloads/Drugs/GuidanceCompliance Regulatory Information/Guidances/UCM072002.pdf, 2005. Accessed January 10, 2014.
    • (2005) Guidance for industry-Premarketing risk assessment
  • 20
    • 80053563163 scopus 로고    scopus 로고
    • Subgroup identification from randomized clinical trial data
    • Foster JC, Taylor JMG, Ruberg SJ. Subgroup identification from randomized clinical trial data. Statistics in Medicine, 30: 2867-2880, 2011.
    • (2011) Statistics in Medicine , vol.30 , pp. 2867-2880
    • Foster, J.C.1    Taylor, J.M.G.2    Ruberg, S.J.3
  • 21
    • 0022072706 scopus 로고
    • Testing for qualitative interactions between treatment effects and patient subsets
    • Gail M, Simon R. Testing for qualitative interactions between treatment effects and patient subsets. Biometrics, 41(2): 361-372, 1985.
    • (1985) Biometrics , vol.41 , Issue.2 , pp. 361-372
    • Gail, M.1    Simon, R.2
  • 23
    • 0022035942 scopus 로고
    • Estimation of a common effect parameter from sparse follow-up data
    • Greenland S, Robins JM. Estimation of a common effect parameter from sparse follow-up data. Biometrics, 41: 55-68, 1985.
    • (1985) Biometrics , vol.41 , pp. 55-68
    • Greenland, S.1    Robins, J.M.2
  • 24
    • 0034736550 scopus 로고    scopus 로고
    • Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies
    • Hahn S, Williamson PR, Hutton JL, Garner P, Flynn EV. Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies. Statistics in Medicine, 19: 3325-3336, 2000.
    • (2000) Statistics in Medicine , vol.19 , pp. 3325-3336
    • Hahn, S.1    Williamson, P.R.2    Hutton, J.L.3    Garner, P.4    Flynn, E.V.5
  • 25
    • 0029874040 scopus 로고    scopus 로고
    • A likelihood approach to meta-analysis with random effects
    • Hardy RJ, Thompson SG. A likelihood approach to meta-analysis with random effects. Statistics in Medicine, 15: 619-629, 1996.
    • (1996) Statistics in Medicine , vol.15 , pp. 619-629
    • Hardy, R.J.1    Thompson, S.G.2
  • 27
  • 28
    • 46449103363 scopus 로고    scopus 로고
    • PREDICT-1 (CNA106030): The first powered, prospective trial of pharmacogenetic screening to reduce drug adverse events
    • Hughes S, Hughes A, Brothers C, Spreen W, Thorborn D. PREDICT-1 (CNA106030): The first powered, prospective trial of pharmacogenetic screening to reduce drug adverse events. Pharmaceutical Statistics, 7: 121-129, 2008.
    • (2008) Pharmaceutical Statistics , vol.7 , pp. 121-129
    • Hughes, S.1    Hughes, A.2    Brothers, C.3    Spreen, W.4    Thorborn, D.5
  • 31
    • 64749108978 scopus 로고    scopus 로고
    • Balancing the benefits and risks of inhaled long-acting beta-agonists-The influence of values
    • Kramer JM. Balancing the benefits and risks of inhaled long-acting beta-agonists-The influence of values. The New England Journal of Medicine, 360(16): 1592-1595, 2009.
    • (2009) The New England Journal of Medicine , vol.360 , Issue.16 , pp. 1592-1595
    • Kramer, J.M.1
  • 33
    • 54549086549 scopus 로고    scopus 로고
    • An efficient method for accommodating potentially underpowered primary endpoints
    • Li J, Mehrotra DV, An efficient method for accommodating potentially underpowered primary endpoints. Statistics in Medicine, 27: 5377-5391, 2008.
    • (2008) Statistics in Medicine , vol.27 , pp. 5377-5391
    • Li, J.1    Mehrotra, D.V.2
  • 34
    • 33846447795 scopus 로고    scopus 로고
    • The probability of observing negative subgroup results when the treatment effect is positive and homogeneous across all subgroups
    • Li Z, Chuang-Stein C, Hoseyni C. The probability of observing negative subgroup results when the treatment effect is positive and homogeneous across all subgroups. Drug Information Journal, 41(1): 47-56, 2007.
    • (2007) Drug Information Journal , vol.41 , Issue.1 , pp. 47-56
    • Li, Z.1    Chuang-Stein, C.2    Hoseyni, C.3
  • 35
    • 80051894060 scopus 로고    scopus 로고
    • Subgroup identification based on differential effect search: A recursive partitioning method for establishing response to treatment in patient subpopulations
    • Lipkovich I, Dmitrienko A, Denne J, Enas G. Subgroup identification based on differential effect search: A recursive partitioning method for establishing response to treatment in patient subpopulations. Statistics in Medicine, 30: 2601-2621, 2011.
    • (2011) Statistics in Medicine , vol.30 , pp. 2601-2621
    • Lipkovich, I.1    Dmitrienko, A.2    Denne, J.3    Enas, G.4
  • 38
    • 0037006623 scopus 로고    scopus 로고
    • Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir
    • Mallal S, Nolan D, Witt C, Masel G, Martin AM, Moore C, Sayer D et al. Association between presence of HLA-B*5701, HLA-DR7, and HLA-DQ3 and hypersensitivity to HIV-1 reverse-transcriptase inhibitor abacavir. Lancet, 359: 727-732, 2002.
    • (2002) Lancet , vol.359 , pp. 727-732
    • Mallal, S.1    Nolan, D.2    Witt, C.3    Masel, G.4    Martin, A.M.5    Moore, C.6    Sayer, D.7
  • 40
    • 84959801619 scopus 로고
    • Statistical aspects of the analysis of data from retrospective studies of disease
    • Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. Journal of the National Cancer Institute, 22: 719-748, 1959.
    • (1959) Journal of the National Cancer Institute , vol.22 , pp. 719-748
    • Mantel, N.1    Haenszel, W.2
  • 41
    • 33646919559 scopus 로고    scopus 로고
    • Systematic review and meta-analysis of ethnic differences in risks of adverse reactions to drugs used in cardiovascular medicine
    • McDowell SE, Coleman JJ, Ferner RE. Systematic review and meta-analysis of ethnic differences in risks of adverse reactions to drugs used in cardiovascular medicine. British Medical Journal, 332(7551): 1177-1181, 2006.
    • (2006) British Medical Journal , vol.332 , Issue.7551 , pp. 1177-1181
    • McDowell, S.E.1    Coleman, J.J.2    Ferner, R.E.3
  • 42
    • 0000781249 scopus 로고
    • Asymptotic efficiency of general noniterative estimators of common relative risk
    • Nurminen M. Asymptotic efficiency of general noniterative estimators of common relative risk. Biometrika, 68: 525-530, 1981.
    • (1981) Biometrika , vol.68 , pp. 525-530
    • Nurminen, M.1
  • 43
    • 33746891192 scopus 로고    scopus 로고
    • Antidepressant drug therapy and suicide in severely depressed children and adults: A case-control study
    • Olfson M, Marcus SC, Shaffer D. Antidepressant drug therapy and suicide in severely depressed children and adults: A case-control study. Archives of General Psychiatry, 63(8): 865-872, 2006.
    • (2006) Archives of General Psychiatry , vol.63 , Issue.8 , pp. 865-872
    • Olfson, M.1    Marcus, S.C.2    Shaffer, D.3
  • 44
    • 53349173117 scopus 로고    scopus 로고
    • Sensitivity of between-study heterogeneity in meta-analysis: Proposed metrics and empirical evaluation
    • Patsopoulos NA, Evangelou E, Ioannidis JP. Sensitivity of between-study heterogeneity in meta-analysis: Proposed metrics and empirical evaluation. International Journal of Epidemiology, 37: 1148-1157, 2008.
    • (2008) International Journal of Epidemiology , vol.37 , pp. 1148-1157
    • Patsopoulos, N.A.1    Evangelou, E.2    Ioannidis, J.P.3
  • 46
    • 33745295856 scopus 로고    scopus 로고
    • Prospective genetic screening decreases the incidence of abacavir hypersensitivity reactions in the western Australian HIV cohort study
    • Rauch A, Nolan D, Martin A, McKinnon E, Almeida C, Mallal S. Prospective genetic screening decreases the incidence of abacavir hypersensitivity reactions in the western Australian HIV cohort study. Clinical Infectious Diseases, 43: 99-102, 2006.
    • (2006) Clinical Infectious Diseases , vol.43 , pp. 99-102
    • Rauch, A.1    Nolan, D.2    Martin, A.3    McKinnon, E.4    Almeida, C.5    Mallal, S.6
  • 47
    • 0023036598 scopus 로고
    • A general estimator for the variance of the Mantel-Haenszel odds ratio
    • Robins J, Greenland S, Breslow NE. A general estimator for the variance of the Mantel-Haenszel odds ratio. American Journal of Epidemiology, 124(5): 719-723, 1986.
    • (1986) American Journal of Epidemiology , vol.124 , Issue.5 , pp. 719-723
    • Robins, J.1    Greenland, S.2    Breslow, N.E.3
  • 48
    • 78649932986 scopus 로고    scopus 로고
    • The mean does not mean as much anymore: Finding subgroups for tailored therapeutics
    • Ruberg SJ, Chen L, Wang Y. The mean does not mean as much anymore: Finding subgroups for tailored therapeutics. Clinical Trials, 7: 574-583, 2010.
    • (2010) Clinical Trials , vol.7 , pp. 574-583
    • Ruberg, S.J.1    Chen, L.2    Wang, Y.3
  • 49
    • 0024929027 scopus 로고
    • On the variance estimator for the Mantel-Haenszel risk difference (letter)
    • Sato T. On the variance estimator for the Mantel-Haenszel risk difference (letter). Biometrics, 45: 1323-1324, 1989.
    • (1989) Biometrics , vol.45 , pp. 1323-1324
    • Sato, T.1
  • 50
    • 84947402121 scopus 로고
    • Rectangular confidence regions for the means of multivariate normal distributions
    • Sidak Z. Rectangular confidence regions for the means of multivariate normal distributions. Journal of the American Statistical Association, 62: 626-633, 1967.
    • (1967) Journal of the American Statistical Association , vol.62 , pp. 626-633
    • Sidak, Z.1
  • 51
    • 0019359389 scopus 로고
    • On summary estimators of relative risk
    • Tarone RE. On summary estimators of relative risk. Journal of Chronic Diseases, 34: 463-468, 1981.
    • (1981) Journal of Chronic Diseases , vol.34 , pp. 463-468
    • Tarone, R.E.1
  • 55
    • 61849117322 scopus 로고    scopus 로고
    • On looking at subgroups
    • Wittes J. On looking at subgroups. Circulation, 119: 912-915, 2009.
    • (2009) Circulation , vol.119 , pp. 912-915
    • Wittes, J.1
  • 56
    • 80051757588 scopus 로고    scopus 로고
    • Bayesian hierarchical modeling for detecting safety signals in clinical trials
    • Xia HA, Ma H, Carlin BP. Bayesian hierarchical modeling for detecting safety signals in clinical trials. Journal of Biopharmaceutical Statistics, 21(5): 1006-1029, 2011.
    • (2011) Journal of Biopharmaceutical Statistics , vol.21 , Issue.5 , pp. 1006-1029
    • Xia, H.A.1    Ma, H.2    Carlin, B.P.3
  • 57
    • 0025737883 scopus 로고
    • Analysis and interpretation of treatment effects in subgroups of patients in randomised clinical trials
    • Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomised clinical trials. JAMA, 266: 93-98, 1991.
    • (1991) JAMA , vol.266 , pp. 93-98
    • Yusuf, S.1    Wittes, J.2    Probstfield, J.3    Tyroler, H.A.4
  • 58
    • 34247636623 scopus 로고    scopus 로고
    • Prospective screening for human leukocyte antigen-B*5701 avoids abacavir hypersensitivity reaction in the ethnically mixed French HIV population
    • Zucman D, Truchis P, Majerholc C, Stegman S, Caillat-Zucman S. Prospective screening for human leukocyte antigen-B*5701 avoids abacavir hypersensitivity reaction in the ethnically mixed French HIV population. Journal of Acquired Immune Deficiency Syndromes, 45: 1-3, 2007.
    • (2007) Journal of Acquired Immune Deficiency Syndromes , vol.45 , pp. 1-3
    • Zucman, D.1    Truchis, P.2    Majerholc, C.3    Stegman, S.4    Caillat-Zucman, S.5


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