ReviewJHEP reports : innovation in hepatology2020
Stratification of patients in NASH clinical trials: A pitfall for trial success.
Review in JHEP reports : innovation in hepatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Systematic review and meta-analysis: analysis of variables influencing the interpretation of clinical trial results in NAFLD.Journal of gastroenterology · 2022Pooled it
- Identifying patient subgroups in MASLD and MASH-associated fibrosis: molecular profiles and implications for drug development.Scientific reports · 2024Article
- Article
- Endpoints in NASH Clinical Trials: Are We Blind in One Eye?Metabolites · 2024Review
- Simulation of Image-Guided Microwave Ablation Therapy Using a Digital Twin Computational Model.IEEE open journal of engineering in medicine and biology · 2024Article
- Innovative Therapeutic Approaches in Non-Alcoholic Fatty Liver Disease: When Knowing Your Patient Is Key.International journal of molecular sciences · 2023Review
- Lessons on Drug Development: A Literature Review of Challenges Faced in Nonalcoholic Fatty Liver Disease (NAFLD) Clinical Trials.International journal of molecular sciences · 2022Review
- Advances and Emerging Therapies in the Treatment of Non-alcoholic Steatohepatitis.TouchREVIEWS in endocrinology · 2022Review
- Advancements in MAFLD Modeling with Human Cell and Organoid Models.International journal of molecular sciences · 2022Review
- Review
- Pathophysiological Mechanisms in Non-Alcoholic Fatty Liver Disease: From Drivers to Targets.Biomedicines · 2021Review
- Insights into Nonalcoholic Fatty-Liver Disease Heterogeneity.Seminars in liver disease · 2021Review
- Outcomes and potential surrogate markers for future clinical trials of non-alcoholic steatohepatitis cirrhosis.Liver international : official journal of the International Association for the Study of the Liver · 2021Review
- Historical narrative from fatty liver in the nineteenth century to contemporary NAFLD - Reconciling the present with the past.JHEP reports : innovation in hepatology · 2021Review
- Perspectives on Precision Medicine Approaches to NAFLD Diagnosis and Management.Advances in therapy · 2021Review
- Analysis of Common Pathways and Markers From Non-Alcoholic Fatty Liver Disease to Immune-Mediated Diseases.Frontiers in immunology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Identifying the most effective therapeutic intervention in patients with NAFLD is challenging. Precise stratification in clinical trials is key to ensuring the inclusion of patients who will benefit (and not those who will be harmed) and/or in whom the natural history can be improved. Clinical trials in NAFLD can provide useful information about the individual components that underlie this complex metabolic disorder and the concomitant medications that could interfere with responses to an experimental intervention. However, to date, clinical trial reporting for NAFLD has been suboptimal, limiting our understanding. Frequently dysmetabolic comorbidities and/or daily habits are not reported or adequately accounted for. Herein, we suggest new strategies to integrate the spectra of comorbidities usually present in patients with NAFLD, accounting for the impact of lifestyle, to develop personalised therapeutic approaches. First, the mechanism of action of the drug being explored should be considered. Second, the same proportion of patients with relevant metabolic comorbidities should be maintained from phase II to III clinical trials, if such comorbidities are expected to impact on the treatment response. Third, innovative trial designs, such as the adaptative, umbrella or basket strategies, could be used to increase the efficiency of clinical trials, potentially benefiting patients while reducing costs and enhancing the likelihood of finding a real benefit of the therapy being studied. Finally, alcohol intake and daily exercise should be assessed objectively not only in the screening period but also during follow-up.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.