The 2026 MS Trial Playbook
The 2024 Revised McDonald Criteria have changed the definition of
the MS patient. ICH-E6(R3) has changed how you monitor them.
Download the operational guide to harmonizing both.
The problem
The “Perfect Storm” for MS Clinical Trials
As we enter 2025, Clinical Operations leaders are facing two simultaneous shifts that fundamentally alter trial design:
- The Diagnostic Shift: The 2024 McDonald Criteria (including Optic Nerve and kFLC) allow for earlier diagnosis. While this speeds up recruitment, it introduces “healthier” patients with lower event rates—putting your statistical power at risk.
- The Regulatory Shift: ICH-E6(R3) mandates a move from retrospective data checking to “Quality by Design.” In this new era, complex biomarkers like the Central Vein Sign (CVS) are no longer just eligibility criteria; they are Critical to Quality (CtQ) factors requiring robust governance.
If your upcoming protocol relies on 2017 diagnostic standards or 1996 monitoring habits, you are already behind.
The solution
What’s Inside the Playbook?
We’ve distilled these complex guidelines into a practical operational manual.
- Side-by-Side Analysis: 2017 vs. 2024 Criteria—what changed and how it impacts your site feasibility.
- The “Optic Nerve” Gate: Why sites without VEP/OCT capabilities will become recruitment bottlenecks.
- kFLC Implementation: How to transition from slow Western Blots to rapid, automated kappa free light chains.
- R3 Data Governance: A blueprint for defining CtQ factors for neuro-imaging and biomarkers.
PLUS: The 10-Point Protocol Audit Checklist
A self-assessment tool to grade your current protocol’s readiness for 2025.
Reading the guidelines is one thing. Operationalizing them across 50+ sites is another.
If you are currently planning a study for late 2025 or 2026, the specific site capabilities for Optic Nerve Assessment (VEP/OCT) will be a major feasibility hurdle.
Our Medical Team is currently offering brief, 30-minute strategy sessions to review site feasibility strategies under the new criteria.
Interested in CAR-T? Read our previous white paper on “Breaking Through the CNS Barrier”. >> Download
