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 helps solidify the overall plan around sound data.

In Issue 25 of The Altascientist: 

• Timing of early clinical pharmacology studies
• Phase I combined protocols
• Special populations
• Resource allocation
• Examples of flexible Phase I study timing

Conducting ethnobridging studies locally, during Phase I clinical trials, in the target population, can reduce drug development timelines by the number of years typically needed to complete clinical development in the target region, as compared with North America or Europe. A Phase I ethnobridging strategy allows you to recruit patients in “global” safety and efficacy trials (Phases II and III) without repeating Phase I development in that region and population.

In Issue 24 of The Altascientist: 

• The importance of Asian ethnobridging in clinical research
• Bridging requirements per the ICH E5 Guidance
• Strategic program considerations per the ICH E7 Guidance
• Accelerating Asian drug development
• Language requirements for global clinical trials
• Altasciences’ expertise and experience with ethnobridging