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Clinical Research Experience

Clinical Research Experience

DANGERS OF SUBGROUP

DANGERS OF SUBGROUP ANALYSES: example from ISIS-2 randomised trial of effects on death of aspirin treatment for heart attacks Astrological birth sign No. of DEATHS ASPIRIN PLACEBO Statistical significance Gemini or Libra (taken together) All other signs (taken together) Any birth signs (i.e. appropriate overall analysis) 150 147 0.5 (NS adverse) 654 869

MERIT-HF: Effects on total mortality of betablocker in heart failure in various subgroups US patient subgroup FDA datasheet: “..mortality plus “Analyses of US patients heart failure hospitalization showed were carried consistent out effects because in the overall study population and subgroups, of the overall including population”. women and the US population. However, in the Why US is subgroup that justification (n=1071) and for women (n=898), overall mortality post hoc data-dependent and cardiovascular mortality appeared emphasis less on affected.” a subgroup? they represented about 25%

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