Methodological Problems in Evaluating Duration of Response to Therapy in Cancer Clinical Trials

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Abstract
In clinical oncology, assessment of therapeutic efficacy is evaluated by several outcome measures of which overall survival, response rate and duration of response are most commonly used. While the evaluation of overall survival is based on clearly defined events and subgroups predefined at the start of observation, the analysis of duration of response emerges to be complicated by a series of methodological difficulties. In this paper, both problems and improved methods related to the evaluation of duration of response are discussed. As an example, artificial data similar to those arising from a recently published study on high-dose chemotherapy in patients with metastatic breast cancer are analyzed by the probability of being in response function.

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