Bridging the gap between oncology clinical trials and real-world data: evidence on replicability of efficacy results using German claims data.

Aims: Using German claims, the authors replicated the CHAARTED trial in metastatic hormone-sensitive prostate cancer. Methods: The authors identified metastatic hormone-sensitive prostate cancer patients replicating the inclusion/exclusion criteria of CHAARTED. Patients treated with docetaxel in combination with androgen deprivation therapy (ADT) at first line (docetaxel group) were compared with patients treated with ADT monotherapy (ADT mono group). After propensity score matching, overall survival was compared between the matched cohorts. Results: The authors included 441 patients. After propensity score matching, two equally sized matched cohorts of 74 patients each were compared in terms of overall survival. The hazard ratio (HR) was 0.71 (95% CI: 0.42-1.19), comparable to the HR in CHAARTED (HR: 0.72; 95% CI: 0.59-0.89). Conclusions: Using early comparative evidence from real-world data for regulatory and health technology assessment decisions is useful.