Ensuring Success of NASH Trials: Best Practices for Optimizing Operations, Enrollment and Retention

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 customized 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 optimizing study operations, maximizing patient enrollment and ensuring study success.

KEY TAKEAWAYS

In this webinar, attendees will:

• Discuss approaches to streamlining the operational conduct of NASH-related studies.
• Learn how to optimize patient enrollment in a competitive environment.
• Understand challenges and methods for maintaining patient engagement throughout the life of the study.

SPEAKERS

Alastair D Smith, MB ChB, FRCP(Glasg), Executive Medical Director

Dr. Smith is a hepatologist, and executive director in the Medical and Scientific Management group. Before joining Syneos Health in 2015, Alastair was an attending hepatologist in the UK (1999 - 2003), and then Medical Director of Liver Transplantation at Duke University, Durham, NC (2003 - 2014). Dr. Smith cared for hundreds of patients with NASH, advanced liver fibrosis and its complications during his pre-industry career. He supported hepatology colleagues at Duke University to identify potential NASH patients for the PIVENS and FLINT studies. Alastair provides strategic medical support to all of our sponsors in the chronic liver disease arena, and is an active member of the Liver Forum.

Luiza Borowska, MD, Executive Director, Clinical Development, Gastroenterology/Hepatology (Europe/Asia)

Dr. Borowska is a former physician with more than 20 years of clinical development industry experience (in both pharmaceutical and CRO sectors). She carries extensive knowledge of commercial and clinical development strategies, together with strong operational execution experience in a wide range of general medicine indications focusing on gastrointestinal and hepatology. Previously head of operations in charge of clinical strategy development within the Asia Pacific region, she is also currently an active member of EASL.

Hans-Juergen Gruss, MD, PhD, Vice President, Clinical Development, Gastroenterology/ Hepatology (Europe/Asia)

Dr. Gruss has more than 25 years of clinical development experience in a wide range of general medicine indications, with a particular focus on gastroenterology and hepatology. Involved in clinical research of chronic liver diseases and cirrhosis for more than 15 years, Dr. Gruss’ knowledge of NASH globally and the treatment of these patients in Europe, in particular, will add important insight into the successful delivery of your trial. He is also currently a member of the Liver Forum.

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