Investigating the impact of open label design on patient-reported outcome results in prostate cancer randomized controlled trials.

Fiche publication


Date publication

août 2020

Journal

Cancer medicine

Auteurs

Membres identifiés du Cancéropôle Est :
Dr THIERY-VUILLEMIN Antoine, Dr MOUILLET Guillaume


Tous les auteurs :
Mouillet G, Efficace F, Thiery-Vuillemin A, Charton E, Van Hemelrijck M, Sparano F, Anota A

Résumé

While open-label randomized controlled trials (RCT) are common in oncology, some concerns have been expressed with regard to Patient-Reported Outcomes (PRO)-based claims stemming from these studies. We aimed to investigate the impact of open-label design in the context of prostate cancer (PCa) RCTs with PRO data.

Mots clés

blinded, health-related quality of life, methodology, patient-reported outcome, prostate cancer, randomized trials

Référence

Cancer Med. 2020 Aug 26;: