How Vital are Patient Reported Outcomes?
Menée à partir de l'analyse de 538 essais cliniques randomisés contrôlés évaluant des traitements anticancéreux, cette étude analyse la validité des résultats des essais cliniques ouverts par rapport à ceux des essais cliniques en aveugle
In this issue of the Journal, Efficace et al. (1) thoughtfully explore whether the blinding of patients in randomized-controlled clinical oncology trials influenced patient-reported outcome (PRO) results between treatment arms. They report that the experimental treatment was not more frequently favored over the standard treatment in open-label trials than in blinded trials. While a non-inferiority analysis would have been preferable, this important study strengthens the validity of PRO results even from open-label cancer randomized clinical trials. The implications of this study are noteworthy because of two key trends in clinical oncology trial design. First, PROs are becoming more common in cancer clinical trial design as primary or secondary endpoints. Second, as this study reports, nearly 70% of the trials reviewed were categorized as open label. This analysis is important as it will help guide the interpretation of future trials incorporating PROs, as well as support the design of novel trials. It further supports the finding that PROs serve as objective and vital measures in clinical oncology trials.