Metabolic dysfunction-associated steatohepatitis (MASH) continues to gain more attention as its global presence and prevalence rise each year. As a result, MASH is now prominent alongside the broader metabolic liver disease classifications. However, this increases trial complexity, from patient screening and enrollment to new and changing regulatory guidance and requirements. In this white paper, we discuss the impact of these changes and the implications for optimal clinical trial design, providing a framework for successfully running MASH clinical trials.
Read the white paper for an in-depth discussion of:
- Current global trials and their impact on emerging markets
- FDA and EMA guidance influences on trial design
- Patient-focused management and screening
- An emerging role for biomarkers and imaging techniques as minimally invasive biopsy alternatives
