What Are the Key Areas of Focus for Regulatory Reforms?
Several key areas are the focus of regulatory reforms in cancer treatment:
1. Streamlining Approval Processes: Simplifying and accelerating the approval process for new cancer drugs through mechanisms like the Breakthrough Therapy Designation and Fast Track status. 2. Adaptive Clinical Trials: Encouraging the use of adaptive clinical trial designs that allow for modifications based on interim results, thus speeding up the development process. 3. Real-World Evidence: Integrating real-world evidence (RWE) from patient experiences and outcomes to supplement clinical trial data. 4. Patient-Centered Approaches: Incorporating patient perspectives and outcomes in the evaluation process. 5. Enhanced Collaboration: Promoting collaboration between regulatory bodies, research institutions, and industry stakeholders.
