Navigating Real-World Evidence (RWE) Guidelines For Optimal Commercial Advantage

By Dr. Neel Patel, Associate Consultant - HEOR, APAC and Rajanikanth Manupati, Associate Consultant - HEOR, APAC, EVERSANA

Developing a new drug therapy is a significant financial and operational challenge, with timelines for discovery through regulatory approval lasting 10-15 years and only 50% of patients adhering to their prescription in the real world. Novel therapeutics also face a high failure rate. Under 10% of medicines make it to Phase I trials and 80% of clinical trials fail to meet enrollment timelines and requirements.

However, digitalized health data, powerful AI technology, and scalable computational power are enabling Real World Evidence (RWE) to offer a pathway for research and market access. RWE unlocks a robust, less costly and more inclusive approach to better healthcare through research and a sustainable life science market. It already plays a key role in the development, authorization and post-authorization supervision of medicines.

Discover how leveraging a RWE approach can help to understand disease progression, monitor patient safety, and assess clinical and cost-effectiveness.