A global approval system for oncology therapies could reduce the number of global cancer-related deaths by 10 percent to 20 percent, according to an Oct. 18 article in Harvard Business Review.
The article authors state the lack of an international system is slowing the approval process for treatments around the world, sometimes by years, resulting in unnecessary death.
The FDA has begun installing an international regulatory infrastructure known as Project Orbis, but the framework needs further internationalization. This system requires all participating nations follow the same criteria in clinical trials, and countries would review applications concurrently. Treatments would be approved faster and be available to patients globally upon approval, according to the article.
The authors recommend the following steps to accelerate adoption of this system:
- Strengthen regulatory bodies.
- Preliminarily define requirements for ethnicity-specific trials.
- Standardize manufacturing inspections.
- Plan for approval in secondary markets.
- Reform insurance coverage for life-prolonging treatments.
Read the full article here.