ReviewHepatology communications2017
Clinical endpoints and adaptive clinical trials in precirrhotic nonalcoholic steatohepatitis: Facilitating development approaches for an emerging epidemic.
Review in Hepatology communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 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
25 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Change in MRI-PDFF and Histologic Response in Patients With Nonalcoholic Steatohepatitis: A Systematic Review and Meta-Analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021Pooled it
- The Asian Pacific Association of the Study of the Liver expert survey on artificial intelligence-assisted reporting of liver histopathology in metabolic dysfunction associated fatty liver disease.Hepatology international · 2026Article
- Novel Aurone Derivative Ameliorates MASH Lipid Metabolism via the AMPK-ACC-PPARα Axis.International journal of molecular sciences · 2025Article
- How improvements in US FDA regulatory process and procedures led to the drug approval for first ever treatment of a common liver disease.Acta pharmacologica Sinica · 2025Review
- Article
- A roadmap for clinical trials in MASH-related compensated cirrhosis.Nature reviews. Gastroenterology & hepatology · 2024Review
- Use of Drug Sensitisers to Improve Therapeutic Index in Cancer.Pharmaceutics · 2024Review
- Emerging therapies for MASLD and their impact on plasma lipids.American journal of preventive cardiology · 2024Article
- Endpoints in NASH Clinical Trials: Are We Blind in One Eye?Metabolites · 2024Review
- Systematic analysis of randomised controlled trials of Chinese herb medicine for non-alcoholic steatohepatitis (NASH): implications for future drug development and trial design.Chinese medicine · 2023Review
- Recent innovations in adaptive trial designs: A review of design opportunities in translational research.Journal of clinical and translational science · 2023Review
- Review
- Article
- Effect of Epidermal Growth Factor Treatment and Polychlorinated Biphenyl Exposure in a Dietary-Exposure Mouse Model of Steatohepatitis.Environmental health perspectives · 2021Article
- X-change symposium: status and future of modern radiation oncology-from technology to biology.Radiation oncology (London, England) · 2021Review
- Review of current controversial issues in clinical trials.General psychiatry · 2021Review
- Current and Potential Therapies Targeting Inflammation in NASH.Frontiers in endocrinology · 2021Review
- Therapeutic approaches for non-alcoholic steatohepatitis.Therapeutic advances in endocrinology and metabolism · 2021Article
- Exercise as Medicine: The Impact of Exercise Training on Nonalcoholic Fatty Liver Disease.Current hepatology reports · 2020Article
- Stratification of patients in NASH clinical trials: A pitfall for trial success.JHEP reports : innovation in hepatology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Due to the increasing prevalence of nonalcoholic steatohepatitis (NASH) and its associated health burden, there is a high need to develop therapeutic strategies for patients with this disease. Unfortunately, its long and asymptomatic natural history, the uncertainties about disease progression, the fact that most patients are undiagnosed, and the requirement for sequential liver biopsies create substantial challenges for clinical development. Adaptive design methods are increasingly used in clinical research as they provide the flexibility and efficiency for identifying potential signals of clinical benefit of the test treatment under investigation and make prompt preplanned adaptations without undermining the validity or integrity of the trial. Given the high unmet medical need and the lack of validated surrogate endpoints in NASH, the use of adaptive design methods appears reasonable. Furthermore, due to the limited number of patients willing to have multiple liver biopsies and the need for long-term exposure to assess an impact in outcomes, a continuous seamless adaptive design may reduce the overall sample size while allowing patients to continue after each one of the phases. Here, we review strategic frameworks that include potential surrogate endpoints as well as statistical and logistical approaches that could be considered for applying adaptive designs to clinical trials in NASH with the goal of facilitating drug development for this growing medical need. (
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.