导 言
科技进步加上未满足病人需求正在加速时间和创造方法开发肿瘤药包括无缝临床试验策略需要不同于传统路径的思维方式
科技进步加之未满足病人需求,驱动加速时间和创造药法开发路径可理解地保持高水平,而精密医学和免疫代谢成就改变了目标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.