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intent-to-treat data: what does it mean?

Dec 26, 1999

Often in clinical data about HIV drugs the term 'intent-to-treat' is also given. What does 'intent-to-treat' mean and how should this data be understood relative to standard results?

Response from Dr. Holodniy

Great question. Intent-to-treat carries forward all patients who enrolled in the study, regardless of whether they finished the study or dropped out because of side effects, toxicity, or choice. This is a more rigorous way to analyze study results. On-treatment analysis only looks at the patients who completed the study, which may bias one treatment arm in favor over another. It is always important to look at study results and the number of patients who started each arm of a study and how many patients are being considered in the final analysis. These may be very different numbers. For instance if 200 patients were enrolled (100 in each of two different treatment arms) and the baseline viral load is compared to the week 24 viral load in 85 patients in arm A and 65 patients in arm B, this will have very different results then if 95 are compared in each arm as intent to treat. MH

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