169P Impact of open-label design on patient-reported outcomes (PROs) data in randomized clinical trials of immuno-oncology (IO) agents in patients with advanced or metastatic cancer: A 10-year systematic literature review (SLR)

ConclusionTo our knowledge, this SLR is the first one to focus on the impact of open-label design on PROs in randomized clinical trials of IO agents using a large search algorithm in the 3 most relevant scientific literature databases. Future research should use patient-level data to investigate potential differences in PROs between open-label and blinded trials.Legal entity responsible for the studyBristol-Myers Squibb.FundingBristol-Myers Squibb.DisclosureA. Anota: Honoraria (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Bristol-Myers Squibb. C. Lefevre: Full / Part-time employment: Bristol-Myers Squibb. H. Lemasson: Full / Part-time employment: Bristol-Myers Squibb. F-E. Cotte: Full / Part-time employment: Bristol-Myers Squibb. G. Mouillet: Honoraria (self): Bristol-Myers Squibb. All other authors have declared no conflicts of interest.
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research