Forecasting Trial Milestones: A Predictive Analysis for Early Termination of the SOUL Study

• DOI: 10.1007/s13300-024-01635-1
• Publication Date: 2024-08-08T09:02:11Z
• Authors: Binayak Sinha; Samit Ghosal
• Keywords: Soul

Semaglutide, a glucagon-like peptide 1 receptor agonist (GLP1RA), is available in both parenteral and oral preparations. Studies of injectable preparations have convincingly demonstrated its beneficial effect on major adverse cardiac events (MACE). This predictive analysis was undertaken to forecast early termination the SOUL trial (oral semaglutide) as well primary events. multicenter, double-blind, placebo-controlled randomized controlled (RCT) evaluating reduction MACE associated with semaglutide versus placebo patients type 2 diabetes (T2D) cardiovascular (CV) disease. A sample 9642 participants will be followed for 5 years months. random-effects model meta-analysis, pooling hazard ratios from previous RCTs, conducted using R software inform model. The background CV event rates arms RCTs were matched pre-adjudicated assumptions create truncated duration, MACE, individual components intervention estimated. predicted difference between two groups estimated chi-squared test. pooled 10,013 revealed significant number MACEs (HR 0.79, 95% CI 0.69–0.91). Predictive indicated that 1225 would achieved by 3.78 years, suggesting premature termination. mathematical based meta-analysis predicts study terminated early, showing benefits terms compared placebo. If corroborates findings this model, it may not only form basis calculation power but also define duration such studies, reducing costs easing process designing outcome trials (CVOTs). INPLASY202460061.