Journal of Clinical Epidemiology
Volume 63, Issue 12 , Pages 1298-1304 , December 2010

Inconsistent trial assessments by the National Institute for Health and Clinical Excellence and IQWiG: standards for the performance and interpretation of subgroup analyses are needed

  • J. Hasford

      Affiliations

    • Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, LMU München, Marchioninistr 15, 81377, München, Germany
    • Corresponding Author InformationCorresponding author. Tel.: +49-89-70957480; fax: +49-89-70957482.
    • ,
  • P. Bramlage

      Affiliations

    • Institute for Cardiovascular Pharmacology and Epidemiology, 15831, Mahlow, Germany
    • ,
  • G. Koch

      Affiliations

    • Department of Biostatistics, University of North Carolina, Chapel Hill, NC 27599, USA
    • ,
  • W. Lehmacher

      Affiliations

    • Institute of Medical Statistics, Informatics and Epidemiology, University of Cologne, 50937 Köln, Germany
    • ,
  • K. Einhäupl

      Affiliations

    • Department of Neurology, Medical School, Charité, 10117 Berlin, Germany
    • ,
  • P.M. Rothwell

      Affiliations

    • Department of Clinical Neurology, Stroke Prevention Research Unit, John Radcliffe Hospital, Oxford OX3 9DU, UK

,Accepted 12 October 2009.

References 

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  3. Rothwell PM. Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation. Lancet. 2005;365:176–186
  4. IQWiG. Final report plan for the evaluation: “clopidogrel versus acetyl salicylic acid in the secondary prevention of vascular events”. 2006. Available at: http://www.iqwig.de/download/A04-1A_Abschlussbericht_Clopidogrel_versus_ASS_in_der_Sekundaerprophylaxe.pdf. Accessed January 21, 2008.
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  15. Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G. Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess. 2001;5:1–56
  16. FDA Advisory Committee. 82nd Meeting of the Cardiovascular and Renal Drugs Committee; October 24, 1997. Available at: http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3338t2.pdf. Accessed January 21, 2008.
  17. EMEA. Points to consider on multiplicity issues in clinical trials. 2002. Available at: http://www.emea.europa.eu/pdfs/human/ewp/090899en.pdf. Accessed September 28, 2009.
  18. Einhäupl KM. Stroke: a run down. Dtsch Ärztebl. 2007;104(23):A1648–1649

 Details of funding: none.

 Conflicts on Interest Disclosures: J.H., P.B., G.K., W.L., K.E., and P.M.R. declare to have received research support from a number of pharmaceutical companies including Sanofi-Aventis.

 Ethical approval: none required.

PII: S0895-4356(09)00365-5

doi: 10.1016/j.jclinepi.2009.10.009

Journal of Clinical Epidemiology
Volume 63, Issue 12 , Pages 1298-1304 , December 2010

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