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In many randomized clinical trials, rescue therapies are available to trial participants due to ethical considerations and/or study design. While providing rescue therapies reflects the real-world practice, it inevitably brings challenges to the treatment evaluation. One traditionally common practice is to delete data after the rescue medication intake. However, recent development of missing data guidance from the regulatory agencies discourages manually removing the "contaminated" data. There are also alternative options:
* quantify the use of rescue medications to a comparable scale with the disease-specific assessments and analyze the 'rescue medication score',
* define efficacy endpoints in a way that is both clinical meaningful and is less dependent on the rescue medication (e.g. the worst pain score during the day, which could be before or after the rescue medication intake), and
* other model-specific approaches
In this talk, we will go through the traditional and alternative approaches for rescue medication handling, with real-world clinical case studies provided as illustrations.
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