The American journal of gastroenterology · 2025
Enrollment in Metabolic Dysfunction-Associated Steatohepatitis Clinical Trials: A Pooled Analysis of Screen Failure Rates.
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Souza Matheus, Al-Sharif Lubna, Diaz Ivanna, Khalil Samira Mohamad
Аннотация
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% confidence interval 50.14-62.23) in 44,949 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.
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% confidence interval 50.14-62.23) in 44,949 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.