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

Background 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. Methods Randomized controlled trials of PCa with a PRO endpoint published between 2004 and 2018 were considered. RCTs were...