Alcohol-related liver disease: Inherent challenges and strategies for successful clinical trial conduct

The association between excessive alcohol consumption and liver disease is well documented. In fact, the effect on alcohol consumption levels during the COVID-19 pandemic has more recently been investigated. In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an additional 8,000 deaths related to alcohol-associated liver disease (ALD) and 18,700 additional cases of decompensated cirrhosis in the United States alone. Similarly, in the United Kingdom, estimations show there was a 24% increase in the amount of alcohol supermarkets sold in the financial year 2020/2021 compared to the year before. Concurrently, alcohol-specific deaths increased by 20% in 2020, with ALD accounting for just over 80% of those deaths. With the only effective treatment for patients whose liver disease has become irreversible being transplantation, the impact of COVID-19 is significant: in 2021, the British Liver Trust estimated there was a 25% decrease in donors. It is therefore critically important that strategies to slow or halt the progression of this disease are implemented before the patient reaches end-stage liver disease.

Challenges are inherent in running clinical trials for ALD, primarily in patient recruitment and retention. Recruiting suitable patients can be challenging as many patients report feeling too sick to participate, wanting to concentrate on abstinence or having a lack of interest in research. While recruitment can be difficult, proactively addressing common questions can be useful. For example, answering the following questions patients typically ask may be beneficial: How will the study benefit me? How much travel do I need to do? Will my current care be impacted? Can I keep my records private? Recruitment issues can also be mitigated by addressing family member concerns and ensuring they fully understand the serious nature of ALD in conjunction with strong engagement from the physician. Studies commonly fail, however, when too many patients do not remain in the study, making endpoints challenging to evaluate. As a first step, the trial protocol must be patient-centric with eligibility criteria and a visit schedule that make it more likely a patient will stay in the study. Suggesting patients participate in alcohol counseling and strongly encouraging abstinence can also be beneficial. To enhance patient retention, make attending visits as easy as possible, for example, by providing transport to the clinical research site, developing a strong relationship between the trial staff and patients and providing ample financial compensation.

Despite the challenges in recruiting and retaining patients with ALD, there is still a great need to develop therapies for this growing group of patients. April 19 is World Liver Day and Labcorp recognizes the importance of addressing alcohol-related liver disease through clinical trials to improve the quality of life for these patients.