Abstract:
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The critical question, in the context of confirmatory oncology drug trials is whether we have a clear answer on the risk-benefit ratio. A comprehensive metric that combines both efficacy and safety endpoints, as well as, patient-reported quality of life endpoints could be very useful in this context. A popular approach is to use a modified overall survival type analysis, where, instead of the usual survival time, a 'quality-adjusted' version of it is analyzed. One such measure is the Q-TWiST, which may be described as the 'quality-adjusted time without symptoms and toxicity'. Originally, QTWiST was developed for the adjuvant setting but has since been extended in several directions. Here, we adapt the QTWiST methodology to our specific situation, which is a two-arm randomized phase III oncology study, in multiple myeloma. While the Q-TWiST methodology itself is fairly well-developed, its application to specific datasets often brings up analytical issues, some of which will be touched upon, as they apply to our study.
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