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Pharmacology · General pharmacology and pharmacokinetics: crossover trial design
Sample itemIn a randomised trial comparing two antihypertensive drugs, each patient takes drug A for 4 weeks, then drug B for 4 weeks, with a 2-week drug-free gap between the periods. The order is randomised. Why is the gap included?
Original practice item, not a recalled exam question. Nothing here is recorded.
The answer and the reasoning
B. To let the first drug's effect wear off so it does not carry over
In a crossover design each patient serves as their own control, which needs a washout period long enough for the first treatment's effects to disappear. Without it, a carry-over effect biases the comparison of the second period. Crossover designs suit stable chronic conditions and cannot be used for curative treatments.
Option by option
A. To keep the observers blind to the allocation
Blinding depends on identical-looking treatments, not on a drug-free interval.
B. To let the first drug's effect wear off so it does not carry over (correct)
Correct. The washout prevents carry-over of the first drug into the second period.
C. To raise the sample size without recruiting more patients
Crossover designs need fewer patients because of paired comparison, but the gap does not itself raise numbers.
D. To allow a placebo run-in to select responders
A placebo run-in comes before randomisation and is not the purpose of a gap between treatments.
Source note: Original NextPrep sample item — pending expert review. This item is original practice material awaiting independent expert review, so confirm important facts in a standard textbook.
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