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Volumn 31, Issue 18, 2012, Pages 1918-1930

Flagging clinical adverse experiences: Reducing false discoveries without materially compromising power for detecting true signals

Author keywords

Adverse experience; Body system; False discovery rate; False positive; Multiplicity adjustment; Safety analysis

Indexed keywords

ADVERSE OUTCOME; ANALYTICAL PARAMETERS; ARTICLE; CAUSAL ATTRIBUTION; CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); COMPARATIVE EFFECTIVENESS; DISEASE SEVERITY; FALSE DISCOVERY RATE; FALSE POSITIVE RESULT; GENETIC ASSOCIATION; HUMAN; MATHEMATICAL ANALYSIS; MATHEMATICAL MODEL; MEHROTRA HEYSE TUKEY METHOD; OUTCOME ASSESSMENT; PATIENT SAFETY; RISK ASSESSMENT; SIGNAL DETECTION; STATISTICAL ANALYSIS;

EID: 84864011873     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5310     Document Type: Article
Times cited : (40)

References (16)
  • 1
    • 54549102355 scopus 로고    scopus 로고
    • Detecting potential safety issues in clinical trials by Bayesian screening
    • DOI: 10.1002/bimj.200710469.
    • Gould AL. Detecting potential safety issues in clinical trials by Bayesian screening. Biometrical Journal 2008 50: 837-851, DOI: 10.1002/bimj.200710469.
    • (2008) Biometrical Journal , vol.50 , pp. 837-851
    • Gould, A.L.1
  • 2
    • 0033566769 scopus 로고    scopus 로고
    • ICH harmonized tripartite guideline: statistical principles for clinical trials
    • ICH Expert Working Group
    • ICH Expert Working Group. ICH harmonized tripartite guideline: statistical principles for clinical trials. Statistics in Medicine 1999 18: 1905-1942.
    • (1999) Statistics in Medicine , vol.18 , pp. 1905-1942
  • 4
    • 0037073578 scopus 로고    scopus 로고
    • Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX™ in healthy infants
    • Kaplan KJ, Rusche SA, Lakkis HD et al. Post-licensure comparative study of unusual high-pitched crying and prolonged crying following COMVAX™ and placebo versus PedvaxHIB™ and RECOMBIVAX™ in healthy infants. Vaccine 2002 21: 181-187.
    • (2002) Vaccine , vol.21 , pp. 181-187
    • Kaplan, K.J.1    Rusche, S.A.2    Lakkis, H.D.3
  • 5
    • 2942677470 scopus 로고    scopus 로고
    • Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture model
    • Berry SM, Berry DA. Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture model. Biometrics 2004 60: 418-426.
    • (2004) Biometrics , vol.60 , pp. 418-426
    • Berry, S.M.1    Berry, D.A.2
  • 6
    • 2942527313 scopus 로고    scopus 로고
    • Use of the false discovery rate for evaluating clinical safety data
    • DOI: 10.1191/0962280204sm363ra.
    • Mehrotra DV, Heyse JH. Use of the false discovery rate for evaluating clinical safety data. Statistical Methods in Medical Research 2004 13: 227-238, DOI: 10.1191/0962280204sm363ra.
    • (2004) Statistical Methods in Medical Research , vol.13 , pp. 227-238
    • Mehrotra, D.V.1    Heyse, J.H.2
  • 7
    • 0001677717 scopus 로고
    • Controlling the false discovery rate: a practical and powerful approach to multiple testing
    • Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. Journal of the Royal Statistical Society B 1995 57: 289-300.
    • (1995) Journal of the Royal Statistical Society B , vol.57 , pp. 289-300
    • Benjamini, Y.1    Hochberg, Y.2
  • 9
    • 0035733108 scopus 로고    scopus 로고
    • The control of the false discovery rate in multiple testing under dependency
    • DOI: 10.1214/aos/1013699998.
    • Benjamini Y, Yekutieli D. The control of the false discovery rate in multiple testing under dependency. Annals of Statistics 2001 29: 1165-1188, DOI: 10.1214/aos/1013699998.
    • (2001) Annals of Statistics , vol.29 , pp. 1165-1188
    • Benjamini, Y.1    Yekutieli, D.2
  • 10
    • 54549094960 scopus 로고    scopus 로고
    • Partitioning to uncover conditions for permutation tests to control multiple testing error rates
    • DOI: 10.1002/bimj.200710471.
    • Calian V, Li D, Hsu JC. Partitioning to uncover conditions for permutation tests to control multiple testing error rates. Biometrical Journal 2008 50: 756-766, DOI: 10.1002/bimj.200710471.
    • (2008) Biometrical Journal , vol.50 , pp. 756-766
    • Calian, V.1    Li, D.2    Hsu, J.C.3
  • 11
    • 34548541559 scopus 로고    scopus 로고
    • Conjunction group analysis: an alternative to mixed/random effect analysis
    • Heller R, Golland Y, Malach R, Benjamini Y. Conjunction group analysis: an alternative to mixed/random effect analysis. NeuroImage 2007 37: 1178-1185.
    • (2007) NeuroImage , vol.37 , pp. 1178-1185
    • Heller, R.1    Golland, Y.2    Malach, R.3    Benjamini, Y.4
  • 12
    • 33746197428 scopus 로고    scopus 로고
    • Adaptive linear step-up procedures that control the false discovery rate
    • DOI: 10.1093/biomet/93.3.491.
    • Benjamini Y, Krieger AM, Yekutieli D. Adaptive linear step-up procedures that control the false discovery rate. Biometrika 2006 93: 491-507, DOI: 10.1093/biomet/93.3.491.
    • (2006) Biometrika , vol.93 , pp. 491-507
    • Benjamini, Y.1    Krieger, A.M.2    Yekutieli, D.3
  • 13
    • 0021832508 scopus 로고
    • Comparative analysis of two rates
    • DOI: 10.1002/sim.4780040211.
    • Miettinen OS, Nurminen M. Comparative analysis of two rates. Statistics in Medicine 1985 4: 213-226, DOI: 10.1002/sim.4780040211.
    • (1985) Statistics in Medicine , vol.4 , pp. 213-226
    • Miettinen, O.S.1    Nurminen, M.2
  • 14
    • 0039396015 scopus 로고    scopus 로고
    • A note on generating correlated binary variables
    • DOI: 10.1093/biomet/85.2.487.
    • Lunn AD, Davies SJ.A note on generating correlated binary variables. Biometrika 1998 85: 487-490, DOI: 10.1093/biomet/85.2.487.
    • (1998) Biometrika , vol.85 , pp. 487-490
    • Lunn, A.D.1    Davies, S.J.2
  • 15
    • 33745719308 scopus 로고    scopus 로고
    • A comparison of eight methods for the dual-endpoint evaluation of efficacy in a proof-of-concept HIV vaccine trial
    • Mehrotra DV, Li X, Gilbert PB.A comparison of eight methods for the dual-endpoint evaluation of efficacy in a proof-of-concept HIV vaccine trial. Biometrics 2006 62: 893-900.
    • (2006) Biometrics , vol.62 , pp. 893-900
    • Mehrotra, D.V.1    Li, X.2    Gilbert, P.B.3
  • 16
    • 33646151608 scopus 로고    scopus 로고
    • Confidence intervals for an exposure adjusted incidence rate difference with applications in clinical trials
    • DOI: 10.1002/sim.2335.
    • Liu GF, Wang J, Liu K, Snavely DB. Confidence intervals for an exposure adjusted incidence rate difference with applications in clinical trials. Statistics in Medicine 2006 25: 1275-1286, DOI: 10.1002/sim.2335.
    • (2006) Statistics in Medicine , vol.25 , pp. 1275-1286
    • Liu, G.F.1    Wang, J.2    Liu, K.3    Snavely, D.B.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.