Posted by : Dr. Frederic FITENI, , Dr. Amélie ANOTA, Dr. Dewi VERNEREY, Dr. Sophie PAGET-BAILLY, Pr. Franck BONNETAIN

Journal name : Expert Review of Anticancer Therapy

Abstract

Overall survival (OS) has been considered as the most relevant primary endpoint but trials using OS often require large numbers of patients and long-term follow-up. Therefore composite endpoints, which are assessed earlier, are frequently used as primary endpoint but suffer from important limitations specially a lack of validation as surrogate of OS. Therefore, Health-related quality of life (HRQoL) could be considered as an outcome to judge efficacy of a treatment. An alternative approach would be to combine HRQoL with composite endpoints as co-primary endpoint to ensure a clinical benefit for patients of a new therapy. The decision rules of such design, the procedure to control the Type I error and the determination of sample size remain questions to debate. Here, we discusses HRQoL as co-primary endpoints in randomized clinical trials in oncology and provide some solutions to promote such design.

Pubmed hyperlink

Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F.

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