We fully support the consensus statement on designing clinical trials to address alcohol use in people with alcohol-associated liver disease (ALD), which aims to standardize and improve the design of ALD trials (Lee, B. P. et al. Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement. Nat. Rev. Gastroenterol. Hepatol. 21, 626–645 (2024))1. The authors highlight the global burden of ALD and the paucity of clinical trials of interventions to reduce or eliminate alcohol use in people with alcohol use disorder (AUD) — a set of recommendations for this field is crucial.

The Consensus Statement provides comprehensive recommendations with clear definitions of liver disease, alcohol use and selection criteria. The consensus development methodology is robust and includes input from an expert panel of hepatologists, addiction medicine specialists, statisticians and clinical trialists, providing clear guidelines on outcomes and endpoints assessments. However, despite the inclusion of an expert panel familiar with this field, there has been a missed opportunity to involve experts by experience: people with lived experience of AUD and/or ALD, their caregivers and their advocates. Their inclusion is essential to provide equipoise with their unique perspectives, insights and recommendations. Thus, there are deficiencies in the statement with regards to recruitment strategies, participant engagement and inclusivity.

Challenges in recruitment and retention were recognized, but generic ideas given on how to approach these issues (Table 5)1. No innovative solutions are provided, nor published evidence of successful trial designs. A systematic review of interventions to improve recruitment to randomized trials identifies potential interventions that could have been included, such as using a bespoke and well-designed information sheet2. There are few published trials in AUD and ALD, and improving recruitment and retention will ensure efficient trial design and prevent wastage due to incomplete outcome data. In a recent abstract, preliminary findings of a systematic review of retention rates in clinical trials in ALD identified 55 trials, of which only three tested an intervention to reduce alcohol use in people with ALD. Overall, attrition was high at 6 months (44%; 95% CI 34–53%)3. Methods to improve trial retention have also been systematically reviewed and have identified potential interventions that apply to people with ALD, including using self-sampling kits and providing monetary and non-monetary incentives4.

The consensus statement also does not fully consider inclusivity in research, which is particularly important as ALD is a disease influenced by disparities; those from deprived communities and ethnic minorities have poorer outcomes from ALD5,6,7. Methods such as using peer support workers with lived experience have been successful in engaging people with hepatitis C in treatment8. Such an intervention could be effective in ALD trials.

We commend this robust framework for designing trials of interventions to reduce alcohol use in people with ALD. Although these new recommendations will help to standardize trial design methodology, more work is needed to understand the acceptability and feasibility of such methodology for people with ALD and their advocates. Further consideration is required to support participant engagement in ALD trials. We therefore call for a consensus on recommendations to improve engagement in clinical trials in people with ALD.