Issue 25: 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 1 do not have to be conducted before Phase 2 commences. Conversely, some studies that are typically done in Phase 2 can be advanced into a Phase 1 combined protocol to have access to key data earlier in the program. Early Phase 1 studies have become increasingly complex when it comes to gathering comprehensive data related to safety and drug pharmacology.

Discover how having early access to trial results and data can help to make inform decisions later in the development journey, support funding opportunities, and help solidify plans around sound data.