How Will Europe Use RWE in Regulatory Decisions and HTAs?

Aetion’s Senior Director of European Business Development Pierre Engel discusses trends in Europe’s use of real world evidence (RWE). He notes that RWE is treated differently by regulatory bodies and health technology assessments (HTAs), with some countries blocking the use of RWE collected elsewhere. He notes that an increasing emphasis has been placed on hiring data scientists to better understand and incorporate RWE into clinical trials. Dr. Engel is optimistic that the use of RWE will continue to grow, leading to more efficient drug development and better outcomes.

According to Dr. Engel, “RWE can support approvals for new indications for drugs already on the market, and this role will grow more robust over time. RWE will also continue to highlight potential safety issues in approved drugs, and may complement clinical trials to strengthen evidence packages. The EMA [European Medicines Agency]—like the FDA—is increasingly open to innovative study designs in the field of safety, such as building external comparator arms for RCTs.” Read more here.

(Source: Pierre Engel, Aetion, 4/15/21)