2021 Webinar: Challenges in NASH Clinical Trials-Challenges in NASH Clinical Trials

Video Transcription

Video Summary

The speakers discuss the challenges of using liver biopsy as a clinical trial endpoint in NASH trials. They highlight the subjective nature of histologic assessment and the variability among pathologists in interpreting biopsy slides. They also discuss the limitations of histologic assessment in identifying patients with fibrotic NASH and in determining response to treatment. They argue that histologic assessment fails to meet the tasks of accurately identifying patients with fibrotic NASH and accurately identifying response to treatment. They propose the use of non-invasive biomarkers as an alternative and more objective method for assessing disease severity and response to treatment. They discuss various non-invasive biomarkers, including serum markers and imaging techniques, and highlight their ability to assess severity, monitor disease changes longitudinally, and correlate with liver-related outcomes. They suggest that these biomarkers could be used as primary endpoints in clinical trials and as a basis for drug approval. They also discuss the need for further research to determine the best combination of biomarkers and to establish thresholds for disease severity and response to treatment. Overall, they argue that non-invasive biomarkers can provide a more accurate and objective assessment of disease severity and response to treatment in NASH trials, and that the field should consider moving away from reliance on liver biopsy as a primary endpoint.

Keywords

liver biopsy

clinical trial endpoint

NASH trials

histologic assessment

pathologists

biopsy slides

fibrotic NASH

response to treatment

non-invasive biomarkers

serum markers

imaging techniques