P49 Comparability of Overall Survival in Real-World and Clinical Trial Data for BRAF+ Advanced Melanoma

External controls based on real-world data (RWD) are increasingly used to complement clinical trial data when assessing effectiveness of treatments in oncology. In the absence of randomization, comparisons between clinical trial and RWD have well-recognized risk of bias, arising from potential differences across these settings in patient populations, diagnostic testing, background therapies and outcome assessments. Suitability of RWD as external controls should be determined on a case-by-case basis considering the RWD source, study outcomes compared, and study design and analysis steps employed to address bias.

Source: Value in Health - December 1, 2023 Category: International Medicine & Public Health Authors: G. Sajeev, K. Chen, G. In, R. Simpson, S. Kalia, D. Christensen, D. Liu, N. Rezai, A. di Pietro, J. Signorovitch Tags: Challenges in Modeling Oncology Outcomes Source Type: research