Juan M. Pericàs, Quentin M. Anstee, Salvador Augustin, Ramón Bataller, Annalisa Berzigotti, Andreea Ciudin, Sven Francque, Juan G. Abraldes, Virginia Hernández-Gea, Mònica Pons, Thomas Reiberger, Ian A. Rowe, Peter Rydqvist, Elmer Schabel, Frank Tacke, Emmanuel A. Tsochatzis, Joan Genescà
{"title":"A roadmap for clinical trials in MASH-related compensated cirrhosis","authors":"Juan M. Pericàs, Quentin M. Anstee, Salvador Augustin, Ramón Bataller, Annalisa Berzigotti, Andreea Ciudin, Sven Francque, Juan G. Abraldes, Virginia Hernández-Gea, Mònica Pons, Thomas Reiberger, Ian A. Rowe, Peter Rydqvist, Elmer Schabel, Frank Tacke, Emmanuel A. Tsochatzis, Joan Genescà","doi":"10.1038/s41575-024-00955-8","DOIUrl":"10.1038/s41575-024-00955-8","url":null,"abstract":"Although metabolic dysfunction-associated steatohepatitis (MASH) is rapidly becoming a leading cause of cirrhosis worldwide, therapeutic options are limited and the number of clinical trials in MASH-related compensated cirrhosis is low as compared to those conducted in earlier disease stages. Moreover, designing clinical trials in MASH cirrhosis presents a series of challenges regarding the understanding and conceptualization of the natural history, regulatory considerations, inclusion criteria, recruitment, end points and trial duration, among others. The first international workshop on the state of the art and future direction of clinical trials in MASH-related compensated cirrhosis was held in April 2023 at Vall d’Hebron University Hospital in Barcelona (Spain) and was attended by a group of international experts on clinical trials from academia, regulatory agencies and industry, encompassing expertise in MASH, cirrhosis, portal hypertension, and regulatory affairs. The presented Roadmap summarizes important content of the workshop on current status, regulatory requirements and end points in MASH-related compensated cirrhosis clinical trials, exploring alternative study designs and highlighting the challenges that should be considered for upcoming studies on MASH cirrhosis. Metabolic dysfunction-associated steatohepatitis (MASH), a primary cause of chronic liver disease (CLD), often leads to advanced CLD stages such as cirrhosis. This Roadmap summarizes the current landscape and challenges of MASH-related compensated cirrhosis clinical trials and explores a way forward for future studies.","PeriodicalId":18793,"journal":{"name":"Nature Reviews Gastroenterology &Hepatology","volume":"21 11","pages":"809-823"},"PeriodicalIF":45.9,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141631321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Disability inclusion in research and health care","authors":"Hannah Kuper, Tom Shakespeare","doi":"10.1038/s41575-024-00958-5","DOIUrl":"10.1038/s41575-024-00958-5","url":null,"abstract":"Globally, one in six people have a disability, and individuals with disabilities often experience a narrow margin of health, less financial security and health disparities. We call for action to improve access to health care for people with disabilities and show how this plan might be achieved.","PeriodicalId":18793,"journal":{"name":"Nature Reviews Gastroenterology &Hepatology","volume":"21 9","pages":"601-602"},"PeriodicalIF":45.9,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141618351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A bloody disgrace — time to change patient safety culture","authors":"Stuart Cantrill","doi":"10.1038/s41575-024-00957-6","DOIUrl":"10.1038/s41575-024-00957-6","url":null,"abstract":"After decades of institutional deceit, deflection, defensiveness and delay, publication of the final report of the Infected Blood Inquiry lays bare the failings of the British state and its National Health Service. Now, it is time for justice, accountability and a change in patient safety culture.","PeriodicalId":18793,"journal":{"name":"Nature Reviews Gastroenterology &Hepatology","volume":"21 8","pages":"530-530"},"PeriodicalIF":45.9,"publicationDate":"2024-07-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141556765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Haitao Liu, Siheng Sean You, Zhigang Gao, Ning Hu, Yunlong Zhao
{"title":"Next generation of gastrointestinal electrophysiology devices","authors":"Haitao Liu, Siheng Sean You, Zhigang Gao, Ning Hu, Yunlong Zhao","doi":"10.1038/s41575-024-00952-x","DOIUrl":"10.1038/s41575-024-00952-x","url":null,"abstract":"This Comment reviews the evolution from early electrophysiological studies to advanced diagnostic tools, highlighting the challenges and innovations shaping the future of gastrointestinal diagnostics.","PeriodicalId":18793,"journal":{"name":"Nature Reviews Gastroenterology &Hepatology","volume":"21 7","pages":"457-458"},"PeriodicalIF":45.9,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141319913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Intermittent fasting for NASH and HCC in mice","authors":"Jordan Hindson","doi":"10.1038/s41575-024-00953-w","DOIUrl":"10.1038/s41575-024-00953-w","url":null,"abstract":"","PeriodicalId":18793,"journal":{"name":"Nature Reviews Gastroenterology &Hepatology","volume":"21 7","pages":"461-461"},"PeriodicalIF":45.9,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141319850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}