A Randomized, Double-Blinded Clinical Trial Was Conducted to Assess the Role

A randomized, double-blinded clinical trial was conducted to assess the role of a multidrug chemotherapy regimen for the treatment of newly diagnosed stage III and IV stomach cancer.  In the study, 150 patients were enrolled in the treatment group and received the new multidrug treatment, and 100 patients were enrolled in the control group and were treated with standard first-line therapy.  All patients were followed for 24 months.  A total of 120 patients in the treatment group (80%) and 80 patients in the control group (80%) died during this follow-up period.  Despite these calculations, the investigators concluded that the new multidrug regimen was more effective than standard therapy.  Which of the following most likely accounts for the conclusion reached by the study investigators?

A) 2-year mortality risk was calculated
B) Observer bias may be present
C) Selective survival bias may be an issue
D) The results were confounded
E) Time-to-event data was analyzed

Correct Answer:

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