CMHC Pulse Blog

Despite these impacts, NASH frequently goes undiagnosed.5,8-11 In addition, its management is challenging since there are no current FDA-approved agents for this condition. However, many agents are being evaluated in clinical trials for the treatment of NASH. To explore some of the challenges and considerations with NASH clinical trials, we spoke with Andrew Roche, PhD, Senior Director, Scientific Affairs at ICON, one of the largest international clinical research organizations with expertise in running NASH studies.

Cardiometabolic Chronicle: Currently, a big part of the problem with NASH is delayed diagnosis or underdiagnosis. How is this affecting NASH clinical trials?

Dr. Roche: Without a doubt, diagnosis remains a challenge on multiple levels, including obtaining and assessing the liver biopsy, which remains the gold standard for diagnosing and staging of NASH12. It’s also believed that a high proportion of NASH patients are undiagnosed because the disease is largely symptomless or causes non-specific symptoms until well advanced. Also, patients and their physicians may prefer to sidestep diagnosis, knowing that the recommended treatment for most patients, improved diet and more exercise, is anyway within their grasp.

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