The Role of Real-World Evidence in Accelerating Drug Development

Nicolas Wolikow, Co-Founder and CEO at Cure51, on Ethical Principles in TechBio

In today’s tech-driven landscape, few sectors are transforming as rapidly as Life Sciences. One of the most game-changing shifts is the growing reliance on real-world evidence (RWE) to accelerate clinical trials and drug development. This evolution has the potential to bring innovative treatments to market faster, improve patient outcomes, and reduce healthcare costs.

From Traditional Trials to Real-World Data

For decades, randomized controlled trials (RCTs) have been the industry gold standard. While effective, they are expensive, slow, and often exclude diverse populations. Enter real-world data (RWD)—collected from electronic health records, insurance claims, registries, and even wearables. When analyzed rigorously, this becomes RWE: a powerful tool that provides insight into how treatments perform in everyday clinical practice.

RWE enables a more granular understanding of drug performance across diverse populations, enhancing relevance and applicability.

Accelerating Clinical Development

RWE is redefining how trials are designed and executed. It helps identify suitable patient populations, boost recruitment, and optimize trial efficiency—especially valuable in rare diseases where traditional recruitment is tough. Adaptive trials and synthetic control arms, particularly in oncology, are already leveraging RWE to reduce reliance on placebos and speed up timelines.

Regulatory Shifts

Regulatory bodies like the FDA and EMA are embracing RWE. The 21st Century Cures Act and programs like EMA’s Adaptive Pathways are examples of how RWE is supporting new drug indications and conditional approvals, especially in areas like oncology, rare diseases, and gene therapies.

Challenges Ahead

Despite the promise, challenges remain. Data quality, standardization, and the observational nature of RWE raise concerns about bias and reliability. Regulatory frameworks are evolving, but clear standards and methodologies are still needed.

At Cure51, we believe RWE is not just complementary to clinical research—it’s a new frontier. If harnessed effectively, it can reshape drug development and bring hope to more patients, faster. As we say: Hope is for Everyone.