Innovative approaches are fueling a new era of real-world study design. Keep up to date with strategic planning best practices and patient-centric, modern study design with our comprehensive white paper, Modern Approaches and Considerations for Designing Real-World Studies.
The Evolution of Real-World Evidence (RWE)
The U.S. FDA’s Advancing Real-World Evidence Program highlights the critical need for generating RWE that meets regulatory requirements (1). As a sponsor, your ability to demonstrate product value depends on strategic planning and patient-centric design that drives stakeholder acceptance.
Three Pillars of Modern RWE Design
Discover an in-depth view of modern RWE study designs and strategies:
Decentralized Study Elements
See how incorporating decentralized tactics dramatically expands the addressable patient population beyond geographic limits.
Integrated Registries Enriched with Real-World Data
Learn why combining multiple registries is a powerful approach, especially in rare disease research.
Data Analysis Plans for RWE Studies
Understand the critical need for developing statistical analysis plans.
Draw on Vast Expertise to Accelerate Your Program
UBC’s Executive Director, Evidence Development Study Solutions, Judy Lytle provides industry-leading expertise on modernized RWE study designs, strategies, and analysis plans in this white paper.
Gain her insights on designing evidence generation strategies, powered by rigorous science and meticulously designed to reliably demonstrate product value to stakeholders.
These insights help guide sponsors through:
- Modernized RWE study designs, strategies, and analysis plans.
- The importance of engaging regulatory agencies early in the process.
- Ensuring studies are planned a priori to satisfy the needs of internal cross-functional partners and external stakeholders, helping to bring therapies to patients sooner.
- The crucial steps for addressing the statistical analysis plan in RWE studies, including defining research questions and addressing confounding, bias, and sensitivity analysis.
Unlock Stakeholder Value and Regulatory Success
Get UBC’s guide to modern RWE study design, covering strategic planning, data integration, and regulatory-grade analytics.
References
- P1. U.S. FDA. “Advancing Real-World Evidence Program.” https://www.fda.gov/drugs/development-resources/advancing-realworld-evidence-program. Accessed 05/24/2023.
