A Randomized, Double-Blinded Clinical Trial Was Conducted to Evaluate the Effect

A randomized, double-blinded clinical trial was conducted to evaluate the effect of a new hypolipidemic drug on the survival of patients after percutaneous coronary intervention (PCI) .  1000 patients undergoing PCI were randomly assigned to the drug or placebo group.  500 patients were in each group.  The 2 groups were then followed for 3 years for the development of acute coronary syndromes.  Severe acute myositis was reported as a rare side effect of the drug therapy, but the difference between the 2 groups in the occurrence of this side effect was not statistically significant (p = 0.09) .  A review of the literature shows that, in prior clinical trials and case reports, the same side effect was noted in some patients taking this drug.  Which of the following is the most likely cause for the failure to detect a significant statistical difference in the occurrence of acute myositis between the treatment and placebo groups in this randomized trial?

A) Ascertainment bias
B) Limited follow-up period
C) Inappropriate patient selection
D) Small sample size
E) Observer bias

Correct Answer:

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