Mikkel Runason Simonsen

WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? External comparator cohorts based on real-world data are increasingly used to contextualize single-arm trials in oncology. However, methodological challenges remain, and certain sources of bias related to sampling strategies in the relapse/post-diagnosis setting have not been systematically described. WHAT QUESTION DID THIS STUDY ADDRESS?

DATA AVAILABILITY STATEMENT The data used in this study are derived from national cancer registries and are not publicly available due to privacy and regulatory restrictions but are available from the respective registry authorities upon reasonable request and with appropriate approvals. REFERENCES 1, . Mantle-cell lymphoma. N Engl J Med. 2022; 386(26): 2495–2506. 2, , , , , , et al.

Conflicts of Interest J.J. reports travel expenses from Roche, Pfizer, and Beigene outside of this work. P.B. reports advisory board from SERB, Roche, Gilead, and Abbvie. T.S.L. reports consultancy/advisory board from BMS, Novartis, Gilead, Roche; research grant from Genentech; and travel expenses from Roche. The other authors declare no conflicts of interest. Data Availability Statement The dataset analyzed in this study cannot be made publicly available due to a data processing agreement.