Health utility adjusted survival: A composite endpoint for clinical trial designs.

ABSTRACT: Many randomized trials have used overall survival as the primary endpoint for establishing non-inferiority of one treatment compared to another. However, if a treatment is non-inferior to another treatment in terms of overall survival, clinicians may be interested in further exploring which treatment results in better health utility scores for patients. Examining health utility in a secondary analysis is feasible, however, since health utility is not the primary endpoint, it is usually not considered in the sample size calculation, hence the power to detect a difference of health utility is not guaranteed. Furthermore, often the premise of non-inferiority trials is to test the assumption that an intervention provides superior quality of life or toxicity profile without compromising surviva

SUBMITTER: Deng Y 

PROVIDER: S-EPMC12541123 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature