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

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.