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Abstract:
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One imperfect but convenient way of classifying clinical trials is on the basis of the type of primary endpoint being evaluated. Two broad classes of endpoints include symptoms, such as pain relief or glucose control, and morbidity/mortality, such as a major adverse cardiovascular event or overall survival. In the case of symptom trials the occurrence of intercurrent events, such as the use of rescue medication, often calls into question the strict application of the intention-to-treat (ITT) estimand. In the case of morbidity/mortality trials, on the other hand, even though such intercurrent events can occur, tradition often calls for strict ITT. In this presentation I will discuss the rationale for this distinction, and argue that the justification for an ITT estimand is the same in both situations.
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