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Volumn 40, Issue 1, 2006, Pages 89-98

Detecting rare adverse events in postmarketing studies: Sample size considerations

Author keywords

Adverse drug reaction; External control; Postmarketing study; Sample size; Two group prospective cohort study

Indexed keywords

NEW DRUG;

EID: 33244455464     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150604000111     Document Type: Article
Times cited : (13)

References (24)
  • 1
    • 0030879777 scopus 로고    scopus 로고
    • Good practice in the post-marketing surveillance of medicines
    • Meyboom RHB. Good practice in the post-marketing surveillance of medicines. Pharm World Sci. 1997;19:186-190.
    • (1997) Pharm World Sci , vol.19 , pp. 186-190
    • Meyboom, R.H.B.1
  • 2
    • 0032522873 scopus 로고    scopus 로고
    • Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies
    • Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998;279:1200-1205.
    • (1998) JAMA , vol.279 , pp. 1200-1205
    • Lazarou, J.1    Pomeranz, B.H.2    Corey, P.N.3
  • 3
    • 25444521373 scopus 로고    scopus 로고
    • July
    • CDER 2003 report to the nation. Available at: http://www.fda.gov/cder/ reports/RTN2003.pdf. July 2004.
    • (2004) CDER 2003 Report to the Nation
  • 4
    • 0008475956 scopus 로고
    • Adverse drug reactions
    • Melmon KL, Morrelli HF, Hoffman BB, Nierenberg DW, eds. New York, NY: McGraw-Hill
    • Glazner FS. Adverse drug reactions. In: Melmon KL, Morrelli HF, Hoffman BB, Nierenberg DW, eds. Clinical Pharmacology, Basic Principles in Therapeutics, 3rd ed. New York, NY: McGraw-Hill; 1992:977-1011.
    • (1992) Clinical Pharmacology, Basic Principles in Therapeutics, 3rd Ed. , pp. 977-1011
    • Glazner, F.S.1
  • 6
    • 0025905614 scopus 로고
    • Spontaneous adverse drug reaction reporting versus event monitoring: A comparison
    • Fletcher AP. Spontaneous adverse drug reaction reporting versus event monitoring: a comparison. J R Soc Med. 1991;84:341-344.
    • (1991) J R Soc Med , vol.84 , pp. 341-344
    • Fletcher, A.P.1
  • 7
    • 0014972035 scopus 로고
    • Statistical aspects of monitoring for dangers in drug therapy
    • Finney DJ. Statistical aspects of monitoring for dangers in drug therapy. Methods Inf Med. 1971;10:1-8.
    • (1971) Methods Inf Med , vol.10 , pp. 1-8
    • Finney, D.J.1
  • 8
    • 0032417803 scopus 로고    scopus 로고
    • Limitations and strengths of spontaneous reports data
    • Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. Suppl C. 1998;20:40-44.
    • (1998) Clin Ther Suppl C , vol.20 , pp. 40-44
    • Goldman, S.A.1
  • 9
    • 0007744281 scopus 로고
    • Pre-existing conditions, placebo reactions, and "side-effects"
    • Green DM. Pre-existing conditions, placebo reactions, and "side-effects." Ann Intern Med. 1964;60:255-265.
    • (1964) Ann Intern Med , vol.60 , pp. 255-265
    • Green, D.M.1
  • 11
    • 0023372821 scopus 로고
    • Rhode Island physicians reporting of adverse drug reactions
    • Scott HD, Rosenbaum SE, Waters WJ. Rhode Island physicians reporting of adverse drug reactions. R J Med J. 1987;70:311-336.
    • (1987) R J Med J , vol.70 , pp. 311-336
    • Scott, H.D.1    Rosenbaum, S.E.2    Waters, W.J.3
  • 12
    • 0023058663 scopus 로고
    • An evaluation of spontaneous adverse drug reaction monitoring systems
    • Sachs RM, Bortnichak EA. An evaluation of spontaneous adverse drug reaction monitoring systems. Am J Med. 1986;81(suppl 5B):49-55.
    • (1986) Am J Med , vol.81 , Issue.SUPPL. 5B , pp. 49-55
    • Sachs, R.M.1    Bortnichak, E.A.2
  • 13
    • 0028072358 scopus 로고
    • False-positives in spontaneous reporting: Should we worry about them?
    • Begaud B, Moride Y, Tubert-Bitter P. False-positives in spontaneous reporting: should we worry about them? Br J Clin Pharmacol. 1994;38:401-404.
    • (1994) Br J Clin Pharmacol , vol.38 , pp. 401-404
    • Begaud, B.1    Moride, Y.2    Tubert-Bitter, P.3
  • 14
    • 0024279780 scopus 로고
    • Guidelines on postmarketing surveillance
    • Joint Committee of ABPI, BMA, CSM, and RCGP. Guidelines on postmarketing surveillance. BMJ. 1988;296:399-400.
    • (1988) BMJ , vol.296 , pp. 399-400
  • 16
    • 0028001085 scopus 로고
    • Guidelines for company-sponsored Safety Assessment of Marketed Medicines (SAMM guidelines)
    • Guidelines for company-sponsored Safety Assessment of Marketed Medicines (SAMM guidelines). Br J Clin Pharmacol. 1994;38:95-97.
    • (1994) Br J Clin Pharmacol , vol.38 , pp. 95-97
  • 17
    • 0017272279 scopus 로고
    • The combination of randomized and historical controls in clinical trials
    • Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis. 1976;29:175-188.
    • (1976) J Chronic Dis , vol.29 , pp. 175-188
    • Pocock, S.J.1
  • 18
    • 0018866647 scopus 로고
    • Sample size consideration for non-randomized comparative studies
    • Makuch RW, Simon RM. Sample size consideration for non-randomized comparative studies. J Chronic Dis. 1980;33:175-181.
    • (1980) J Chronic Dis , vol.33 , pp. 175-181
    • Makuch, R.W.1    Simon, R.M.2
  • 19
    • 0025005369 scopus 로고
    • Incorporating historical control data in planning phase II clinical trials
    • Thall PF, Simon RM. Incorporating historical control data in planning phase II clinical trials. Stat Med. 1990;9:215-228.
    • (1990) Stat Med , vol.9 , pp. 215-228
    • Thall, P.F.1    Simon, R.M.2
  • 20
    • 0036403197 scopus 로고    scopus 로고
    • Sample size calculation for a historically controlled clinical trial with adjustment for covariates
    • O'Malley AJ, Normand S-LT, Kuntz RE. Sample size calculation for a historically controlled clinical trial with adjustment for covariates. J Biopharm Stat. 2002;12:227-247.
    • (2002) J Biopharm Stat , vol.12 , pp. 227-247
    • O'Malley, A.J.1    Normand, S.-L.T.2    Kuntz, R.E.3
  • 21
    • 0028212602 scopus 로고
    • Sample size calculations for single groups postmarketing cohort studies
    • Tubert-Bitter P, Begaud B, Moride Y, Abenhaim L. Sample size calculations for single groups postmarketing cohort studies. J Clin Epidemiol. 1994;47:435-439.
    • (1994) J Clin Epidemiol , vol.47 , pp. 435-439
    • Tubert-Bitter, P.1    Begaud, B.2    Moride, Y.3    Abenhaim, L.4
  • 22
    • 0016255002 scopus 로고
    • Power computations for designing comparative Poisson trials
    • Gail M. Power computations for designing comparative Poisson trials. Biometrics. 1974;30:231-237.
    • (1974) Biometrics , vol.30 , pp. 231-237
    • Gail, M.1
  • 23
    • 0242390575 scopus 로고
    • Experiment size and power comparisons for two-sample Poisson tests
    • Shiue W-K, Bain LJ. Experiment size and power comparisons for two-sample Poisson tests. Appl Stat. 1982;31:130-134.
    • (1982) Appl Stat , vol.31 , pp. 130-134
    • Shiue, W.-K.1    Bain, L.J.2
  • 24
    • 0347137498 scopus 로고    scopus 로고
    • Power and sample size requirements for tests of differences between two Poisson rates
    • Thode CH. Power and sample size requirements for tests of differences between two Poisson rates. Statistician. 1997;46:227-230.
    • (1997) Statistician , vol.46 , pp. 227-230
    • Thode, C.H.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.