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Reply to ‘An expert panel Consensus Statement on ALD without experts by experience’

Nature Reviews Gastroenterology & Hepatology volume 21, page 886 (2024)Cite this article

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We thank Avades and colleagues for the opportunity to expand on our expert panel consensus statement (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 to highlight the important role of persons with lived experience of alcohol use disorder (AUD) and/or alcohol-associated liver disease (ALD), their caregivers and their advocates in clinical trials (Avades, T. et al. An expert panel Consensus Statement on ALD without experts by experience. Nat. Rev. Gastroenterol. Hepatol. https://doi.org/10.1038/s41575-024-00994-1 (2024))2. Including these voices is critical to guide the design of clinical trials, recruitment and retention efforts, and, most importantly, the implementation of findings for the individuals most affected by these diseases.

Engaging persons with lived or living experience can improve recruitment and retention, which are suboptimal in clinical trials for ALD3,4. For example, the TREAT Consortium found that half of individuals with alcohol-associated hepatitis eligible for a clinical trial declined enrolment, and only 35% of participants recruited for an observational study returned for 6-month and 12-month follow-up visits3. Engaging persons with lived or living experience can also be empowering5, particularly for a disease state often associated with high levels of emotional distress and uncertainty6,7. Person-centred approaches are important in integrated treatment for AUD and ALD8, and persons with lived or living experience can provide critical feedback when developing these approaches for clinical trial design for AUD and/or ALD9.

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References

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Acknowledgements

This Reply has been written by the authors on behalf of all authors of the expert panel Consensus Statement on designing clinical trials for AUD in patients with ALD.

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Authors and Affiliations

  1. Center on Alcohol, Substance use and Addictions, University of New Mexico, Albuquerque, NM, USA

    Katie Witkiewitz

  2. Department of Internal Medicine, Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA

    Jessica L. Mellinger

  3. Division of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine, Los Angeles, CA, USA

    Brian P. Lee

  4. Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA

    Brian P. Lee

  5. Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA

    Srinivasan Dasarathy

  6. Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA

    Laura E. Nagy

  7. Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA

    Mack C. Mitchell

Authors
  1. Katie Witkiewitz
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  2. Jessica L. Mellinger
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  3. Brian P. Lee
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  4. Srinivasan Dasarathy
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  6. Mack C. Mitchell
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Corresponding authors

Correspondence to Laura E. Nagy or Mack C. Mitchell.

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Competing interests

K.W. is a member of the Alcohol Clinical Trials Initiative (ACTIVE) Workgroup. In the past 36 months, its activities were supported by Alkermes, Dicerna, Ethypharm, Lundbeck, Mitsubishi and Otsuka. J.L.M. is a consultant for GlaxoSmithKline. B.P.L. is a consultant for GlaxoSmithKline, Novo Nordisk and HepaTX. M.C.M. is a consultant for GlaxoSmithKline, Prodigy, HepaTX and a Board member of Amygdala Neuroscience; there is research support to his institution from Durect. The other authors declare no competing interests.

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Witkiewitz, K., Mellinger, J.L., Lee, B.P. et al. Reply to ‘An expert panel Consensus Statement on ALD without experts by experience’. Nat Rev Gastroenterol Hepatol 21, 886 (2024). https://doi.org/10.1038/s41575-024-00995-0

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