In an effort to improve timely access for patients to new medicines in areas of high unmet need, the European Medicines Agency (EMA) has implemented an innovative adaptive pathways approach. Adaptive pathways is a scientific concept for medicine development and data generation, which allows for early and progressive patient access to a medicine using the existing European Union regulatory framework.
Adaptive pathways are based on the principles of iterative development throughout the life-cycle of a medicine where clinical trial data is supplemented by real-world evidence. A key principle is early patient and health technology board engagement. Adaptive pathways seeks to achieve an appropriate trade-off between unmet need and a wider than traditional degree of uncertainty around risks and benefits. This approach expedites access to new medicines whilst at the same time ensuring that the evidence gap is progressively filled.
Join Quintiles experts Dr. Stella Blackburn, VP, Risk Management, Real-World & Late Phase Research & Janice Haigh, Principal, Advisory Services as they discuss: