You conduct a clinical trial study and randomly assign 1,000 patients to drug A

Question

You conduct a clinical trial study and randomly assign 1,000 patients to drug A and 1,000 patients to drug B. Among patients assigned to Drug A, 600 complete the trial. Among patients assigned to Drug B, 800 complete the trial. Among the 600 Drug A completers, 30 die during the study. Among the 800 Drug B completers, 40 die during the study. Among the 400 Drug A non-completers, 75 die. Among the 200 Drug B non-completers, 150 die. Using both an as-treated and intention-to-treat approach, calculate the death rate for both Drug A and Drug B. Show all calculations.

Explanation / Answer

Total patients assigned Complete the trial

Drug A - 1000 600

Drug B - 1000 800

Among the above completers, the number of deaths during the study

Drug A - 30

Drug B - 40

Among the non-completers, the number of deaths

Drug A - 75

Drug B - 150

The deaths associated with as treated approach

For Drug A - 30 / 600 x 100 = 5%

For Drug B - 40 / 800 x 100 = 5%

The deaths associated with intention to treat approach

For Drug A - 75 / 400 x 100 = 18.8%

For Drug B - 150 / 200 x 100 = 75%

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