Ayman Mohammad

May 1, 2024 | jamanetwork.com | Maryam Mooghali |Yale Collaboration |Ayman Mohammad |Joshua D. Wallach

Introduction The US Food and Drug Administration (FDA) launched the Real-Time Oncology Review (RTOR) program in 2018 to support earlier review of oncology therapeutics expected to be a substantial improvement over available therapy based on straightforward study designs and easily interpreted end points.1 Although RTOR applications have been associated with shorter median approval times,2,3 little is known about the evidence supporting RTOR indication approvals.