Toward incorporating health-related quality of life as co-primary endpoints in clinical trials: time to achieve clinical important differences and quality of life profiles

J Clin Oncol

16 May 2022 - Besides morbidity and mortality, quality of life is a key outcome of cancer treatments. 

Trials on the basis of clinical outcomes have expectations that quality of life outcomes can be either tolerated or improved. 

Simultaneously considering quality of life and clinical outcomes is challenging with lack of suitable metrics allowing incorporation of quality of life as co-primary end points in clinical trial design and utilisation of hierarchical hypothesis testing.

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Michael Wonder

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Michael Wonder