Panel Discussion: Given Recent Failures, How Can We Tailor ALS Clinical Trials to Successfully Meet Regulatory Expectations
2:10 pm - Wednesday 3rd June 2026
- Leveraging innovative trial designs, such as adaptive, Bayesian, and platform models (e.g., MAGNET), alongside advanced outcome measures including PROs and digital endpoints to enhance trial success
- Defining clear, patient-relevant endpoints and integrating biomarkers to more effectively demonstrate clinical efficacy
- Navigating and aligning divergent regulatory expectations across agencies (e.g., FDA, EMA) to optimise trial design and approval pathways
- Identifying and mitigating late-stage risks by addressing common Phase 3 failure points and strengthening earlier-stage trial design, including adaptive Phase 2b approaches
