Assessing the impact of open-label designs in patient-reported outcomes: investigation in oncology clinical trials.

ABSTRACT:

Background

Knowledge of treatment assignment may affect patient-reported outcomes (PROs), which is of concern in oncology, where open-label trials are common. This study measured the magnitude of open-label bias by comparing PROs for similar patient groups in oncology trials with different degrees of concealment.

Methods

Individual patient data from ipilimumab arms of 2 melanoma and docetaxel arms of 2 non-small cell lung cancer (NSCLC) trials were adjusted for differences using propensity score weighting. Patients were aware of treatment assignment in CA184-022 and CheckMate 057 (open-label) but not in MDX010-20 and VITAL (blinded). Overall survival (OS) and mean changes from baseline to week 12 in the European Organization for Research and Treatment of Cancer Quality of Li

SUBMITTER: Lord-Bessen J 

PROVIDER: S-EPMC10023242 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature