Conclusion

This cross-sectional study found 47% of articles reporting on QoL in oncology RCTs did not use QoL questionnaires directly assessing financial toxicity. Additionnaly, the study drug was supplied by the sponsor in most trials. Financial toxicity occurs in real-life settings when patients have to pay for the drugs and other medical expenses. QoL assessments from oncology RCTs lack generalizability to real-world settings, due to limited querying of financial toxicity.

Policy Summary

Real-world evidence could be demanded by regulators as post-requirement studies to ensure QoL results observed in trials will replicate in patients treated outside investigational trials.

https://www.sciencedirect.com/science/article/pii/S2213538323000401