A Different Route to Faster Approvals

White Paper

February 1, 2019
A Different Route to Faster Approvals
This white paper explores considerations critical during protocol design to help ensure the best way forward, including how a seamless clinical trial strategy requires a different mindset than traditional pathways. Advancements in science and technology, combined with unmet patient needs, are driving accelerated timelines and creative pathways for oncology drug development. Oncology sponsors and regulators alike seek new ways to efficiently move promising therapies from the clinic to approval, and have started to embrace a streamlined path that bypasses the traditional development paradigm of standalone sequential Phase I, II and III trials.