Flexibility In Phase I Study Timing

The structure of an early phase drug development pathway is not set in stone. In fact, certain studies that are generally considered Phase I do not have to be conducted before Phase II commences. Conversely, some studies that are typically done in Phase II can be advanced into a Phase I combined protocol to have access to key data earlier in the program. Early Phase I studies have become increasingly complex, in order to gather comprehensive data related to safety and drug pharmacology. Having early access to trial results and data helps inform decisions later in the development journey, can support funding opportunities, and help solidify the overall plan around sound data.

Partnering with a CRO team that has the knowledge and experience to design each program according to the sponsors’ needs, considering flexibility to perform specific analyses early (in Phase I) or later (Phase II and beyond) is ideal. Experts will incorporate and analyze early signals that point to specialized analyses being included or waived, and the development pathway is structured to maximize efficient timelines and budget.