Zhaohui Su, VP, Strategic Consulting at Veristat, shared a post on LinkedIn:
“Randomized clinical trials (RCT) and real-world evidence (RWE) are converging into a unified strategy.
Organizations that effectively integrate real-world data (RWD) across silos and functions will gain a significant advantage in speed, cost, and ultimately, patient impact.
A recent article by Hana D., Victoria Zhang, Mary Jo Lamberti, and Craig Morgan highlights the rapid evolution of this landscape:
- RWD is now embedded across the development lifecycle. From early epidemiology and target identification to trial design, feasibility, and commercialization, teams increasingly rely on RWD to inform their decisions.
- Trial design is becoming more data-driven. Sponsors are utilizing RWD to refine eligibility criteria, optimize sample sizes, select endpoints, and even enable external control arms (ECA) and hybrid trial designs, particularly in rare disease and pediatric settings.
- Efficiency gains are tangible. Access to existing data accelerates recruitment, reduces patient burden, and shortens timelines, facilitating faster market entry for therapies.
- Challenges still need to be addressed. Data quality, fragmentation, and linkage issues remain significant barriers, along with the need for internal alignment and demonstrating return on investment.
- AI will be a major unlock. As AI and machine learning advance, and longitudinal datasets improve, we can expect stronger integration of RWD into trial execution, regulatory strategy, and precision medicine.
RWD is no longer supporting evidence. It is becoming core infrastructure for modern clinical development.
I am interested in how others are integrating RWD and RWE into their trial design and decision-making strategies. Please leave comments or reach out to Veristat to continue the conversation.”
Title: The Use of Real-World Data and Evidence in Clinical Trials
Authors: Hana Do, Victoria Zhang, Mary Jo Lamberti, Craig Morgan
Other articles featuring Zhaohui Su on OncoDaily.