Case Study: 1,000 Voices: Rapidly Assembling a Patient Cohort to Redefine Anticoagulant Development
The Challenge
For new anticoagulants targeting atrial fibrillation, regulatory decisions
were made without a clear understanding of what patients actually value.
Traditional endpoints ignored meaningful quality-of-life tradeoffs, limiting
real-world adoption and regulatory momentum.
The PreMatch360 Solution
PreMatch360 built a nationwide cohort of over 1,000 patients with atrial fibrillation to inform trial design and regulatory strategy. Leveraging both
site-based and direct-to-patient approaches, we engaged participants quickly and at scale. The project:
- Captured preference data on clinical and quality-of-life outcomes
- Developed a framework to estimate benefit based on patient values
- Integrated with clinical trial analyses and regulatory documentation
- Developed preference-based benefit-risk model
Why It Matters
PreMatch360 delivered more than a cohort. It delivered clarity. By rapidly enrolling patients and quantifying what matters most to them, sponsors gained a competitive edge in designing trials that resonate with both regulators and the real world.
Impact
1,000+ participants enrolled using hybrid recruitment strategies
High-quality preference data, at scale
Direct influence on trial endpoint selection and weighting
New methodologies adopted for regulatory and market access use
Published in high-impact journal (1)