Advancements in science and technology, combined with unmet patient needs, are driving accelerated timelines and creative pathways for oncology drug development. While public desire for novel and effective treatments understandably remains high, precision medicine and immunotherapeutic achievements have shifted the goals. Researchers and clinicians want to develop transformative medicines with less toxicity than traditional chemotherapies that curtail progression of cancers and their recurrences, if not eradicate them. With such treatments in mind, oncology sponsors and regulators alike seek new ways to efficiently move promising therapies from the clinic to approval, and have started to embrace a seemingly seamless path that bypasses the traditional development paradigm of stand-alone sequential Phase I, II and III trials. Today, when sponsors see strong responses during early development, they may consider a faster path to approval via single-arm studies or early phase expansion cohort trials conceived to gather pivotal data. Regulatory authorities have embraced these innovative approaches. As a specialty oncology clinical research organization, IQVIA Biotech counsels sponsors considering these routes to consider several aspects during protocol design to ensure the best way forward, including how a seamless clinical trial strategy requires a different mindset than traditional pathways.
This white paper explores several aspects during protocol design to ensure the best way forward, including how a seamless clinical trial strategy requires a different mindset than traditional pathways.