Enrollment in Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials: A Pooled Analysis of Screen Failure Rates.

IF 8 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

American Journal of Gastroenterology Pub Date : 2025-05-05 DOI:10.14309/ajg.0000000000003520

Matheus Souza, Lubna Al-Sharif, Ivanna Diaz, Samira Mohamad Khalil

{"title":"Enrollment in Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials: A Pooled Analysis of Screen Failure Rates.","authors":"Matheus Souza, Lubna Al-Sharif, Ivanna Diaz, Samira Mohamad Khalil","doi":"10.14309/ajg.0000000000003520","DOIUrl":null,"url":null,"abstract":"Introduction: Screen failure is a major challenge in the enrollment of metabolic dysfunction-associated steatohepatitis (MASH) randomized controlled trials (RCTs) but its impact has not been systematically assessed.Methods: We searched PubMed and the Cochrane Library databases for phase ≥2 RCTs of MASH pharmacotherapies in adults using histological inclusion criteria. Screen failure rates (SFRs) were pooled using a generalized linear mixed model.Results: Of 67 included RCTs, 58 reported enrollment data. The pooled SFR was 56.28% (95% CI 50.14 to 62.23) in 44949 individuals. The most common reason for screen failure was ineligibility. SFR was higher in more recent trials, globally conducted trials, and trials funded by pharmaceutical companies. Meta-regressions showed an increase in SFR over time and with more trial sites.Discussion: Evidence-based strategies to reduce the high SFR in MASH clinical trials are urgently needed.","PeriodicalId":7608,"journal":{"name":"American Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":8.0000,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.14309/ajg.0000000000003520","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: Screen failure is a major challenge in the enrollment of metabolic dysfunction-associated steatohepatitis (MASH) randomized controlled trials (RCTs) but its impact has not been systematically assessed.

Methods: We searched PubMed and the Cochrane Library databases for phase ≥2 RCTs of MASH pharmacotherapies in adults using histological inclusion criteria. Screen failure rates (SFRs) were pooled using a generalized linear mixed model.

Results: Of 67 included RCTs, 58 reported enrollment data. The pooled SFR was 56.28% (95% CI 50.14 to 62.23) in 44949 individuals. The most common reason for screen failure was ineligibility. SFR was higher in more recent trials, globally conducted trials, and trials funded by pharmaceutical companies. Meta-regressions showed an increase in SFR over time and with more trial sites.

Discussion: Evidence-based strategies to reduce the high SFR in MASH clinical trials are urgently needed.

查看原文本刊更多论文

代谢功能障碍相关脂肪性肝炎临床试验的登记：筛选失败率的汇总分析

筛选失败是代谢功能障碍相关脂肪性肝炎（MASH）随机对照试验（rct）入组的主要挑战，但其影响尚未得到系统评估。方法：我们使用组织学纳入标准检索PubMed和Cochrane图书馆数据库中成人MASH药物治疗的≥2期随机对照试验。筛选失效率（SFRs）采用广义线性混合模型进行汇总。结果：67个纳入的随机对照试验中，58个报告了入组数据。44949人的总SFR为56.28% （95% CI 50.14 ~ 62.23）。筛查失败最常见的原因是不合格。在最近的试验、全球开展的试验和由制药公司资助的试验中，SFR更高。meta回归显示SFR随时间和试验地点的增加而增加。讨论：迫切需要循证策略来降低MASH临床试验中的高SFR。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

American Journal of Gastroenterology 医学-胃肠肝病学

CiteScore

11.40

自引率

5.10%

发文量

458

审稿时长

12 months

期刊介绍： Published on behalf of the American College of Gastroenterology (ACG), The American Journal of Gastroenterology (AJG) stands as the foremost clinical journal in the fields of gastroenterology and hepatology. AJG offers practical and professional support to clinicians addressing the most prevalent gastroenterological disorders in patients.