Review
Open access
Sep 2026
PRO‑CTCAE in Oncology Drug Evaluation: Cross-Agency Review of Regulatory and Health Technology Assessment Decision-Making in the United States and Europe.
Harmonized, cross-agency guidance on PRO-CTCAE item selection, endpoint definition, analysis, and presentation may help support its consistent and meaningful use in future oncology submissions and regulatory and HTA decision-making.
E. Basch, Matthew Reaney, J. Roydhouse et al.
· Journal of the National Canc... · 0 citations