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Editorial

International central adjudication committee in the PLATO trial: independent body of experts or friendly family picnic?

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References

  • Cook D, Sinuff T, Zytaruk N, et al. DIRECT Investigators and Canadian Critical Care Trials Group. Event adjudication and data monitoring in an intensive care unit observational study of thromboprophylaxis. J Crit Care 2009;24(2):168-75
  • Granger CB, Vogel V, Cummings SR, et al. Do we need to adjudicate major clinical events? Clin Trials 2008;5(1):56-60
  • Jovanović DR, Algra A, van Gijn J, Dutch TIA. Trial Study Group. Classification of outcomes events in the Dutch TIA trial: prognostic value of accepted and rejected events. Curr Med Res Opin 2004;20(3):255-8
  • Dechartres A, Boutron I, Roy C, Ravaud P. Inadequate planning and reporting of adjudication committees in clinical trials: recommendation proposal. J Clin Epidemiol 2009;62(7):695-702
  • Serebruany VL, Atar D. Central adjudication of myocardial infarction in outcome-driven clinical trials - common patterns in TRITON, RECORD, and PLATO? Thromb Haemost 2012;108(3):412-14
  • Verheugt FW. Outcomes of positive randomised controlled clinical trials: double-blind or double vision? Thromb Haemost 2012;108(3):410-11
  • Wallentin L, Becker RC, Budaj A, et al. the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009;361(11):1045-57
  • The FDA ticagrelor secondary review. Available from: http://fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM220192.pdf [Last assessed 21 July 2013]
  • The FDA ticagrelor review of complete response. Available from: http://accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000TOC.cfm [Last assessed 21 July 2013]
  • DiNicolantonio JJ, Tomek A. Inactivations, deletions, non-adjudications, and downgrades of clinical endpoints on ticagrelor: serious concerns over the reliability of the PLATO trial. Int J Cardiol 2013;168(4):4076-80
  • Serebruany VL. Paradoxical excess mortality in the PLATO trial should be independently verified. Thromb Haemost 2011;105(5):752-9
  • Wallentin L, Becker RC, James SK, Harrington RA. The PLATO trial reveals further opportunities to improve outcomes in patients with acute coronary syndrome. Thromb Haemost 2011;105(5):760-2
  • Ohman EM, Roe MT. Explaining the unexpected: insights from the PLATelet inhibition and clinical outcomes (PLATO) trial comparing ticagrelor and clopidogrel. Thromb Haemost 2011;105(5):763-5

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