Ensuring Success of NASH Trials
Syneos Health is hosting a webinar on Best Practices for Optimising Operations, Enrollment and Retention of NASH Trials.
Driven by rising rates of obesity and diabetes, nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) have replaced hepatitis C virus infection as the most common cause of chronic liver disease worldwide. With no Food and Drug Administration (FDA)-approved treatments available, patients confront a substantial unmet need. However, the prospects for drug development have begun to brighten as understanding of liver disease pathophysiology, diagnosis, epidemiology and natural history evolve at a remarkable pace.
As this field of research continues to expand, however, high study competition and subject burden combined with limited availability of appropriately skilled hepatologists pose significant challenges for NASH clinical trials, particularly in patient enrollment and retention. Overcoming these challenges through a site-centric approach built on customised recruitment strategies, continuous site identification and site relationship management is key to accelerating the clinical development of NAFLD/NASH therapies.
This webinar will provide insights into this approach based on experience in more than 20 NAFLD/NASH clinical trials within the last five years across all study phases, with 3,000 patients enrolled across more than 1,000 clinical hepatologist sites across the world, with a focus on best practices for optimising study operations, maximising patient enrollment and ensuring study success.
In this webinar, attendees will:
- Discuss approaches to streamlining the operational conduct of NASH-related studies.
- Learn how to optimise patient enrollment in a competitive environment.
- Understand challenges and methods for maintaining patient engagement throughout the life of the study.
- Alastair D Smith, MB ChB, FRCP(Glasg), Executive Medical Director, Syneos Health
- Luiza Borowska, MD, Executive Director, Clinical Development, Gastroenterology/Hepatology (Europe/Asia), Syneos Health
- Hans-Juergen Gruss, MD, PhD, Vice President, Clinical Development, Gastroenterology/ Hepatology (Europe/Asia), Syneos Health