1. Food and Drug Administration (FDA). Project FrontRunner. Rockville, MD. https://www.fda.gov/about-fda/oncology-center-excellence/project-frontrunner (accessed March 11, 2023).
2. The on- and off-ramps of oncology accelerated approval;Fashoyin-Aje;N. Engl. J. Med.,2022
3. Food and Drug Administration (FDA). Clinical trial considerations to support accelerated approval of oncology therapeutics (draft). Rockville, MD. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-considerations-support-accelerated-approval-oncology-therapeutics (accessed April 2, 2023).
4. Food and Drug Administration (FDA). Multiple endpoints in clinical trials - guidance for industry. Rockville, MD. https://www.fda.gov/media/162416/download (accessed March 11, 2023).
5. European Medicine Agency (EMA). Guideline on multiplicity issues in clinical trials. London: EMA. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-multiplicity-issues-clinical-trials_en.pdf (accessed March 11, 2023).