Benefits of Reducing Clinical Trial Costs

The proposed decentralized FDA (dFDA) system aims to dramatically reduce the cost of clinical trials from $100 million to under $200,000 per new treatment. This 500-fold reduction in costs could have far-reaching implications for global health, scientific progress, and economic benefits. Let’s break down the potential impacts:

1. Increased Number of Treatments Developed

Current Scenario:

• Assuming a global annual investment of $100 billion in clinical trials
• Number of new treatments per year = $100 billion / $100 million = 1,000 treatments

With dFDA:

• Same $100 billion investment
• Number of new treatments per year = $100 billion / $200,000 = 500,000 treatments

Potential Impact: 499,000 additional treatments could be developed annually.

2. Accelerated Research for Rare Diseases

• Presently, about 95% of rare diseases lack FDA-approved treatments
• There are approximately 7,000 known rare diseases affecting 400 million people worldwide

Potential Impact: If just 1% of the additional treatments (4,990) focused on rare diseases, we could develop many new treatments. These new treatments could address 71% of all rare diseases within a single year. This would dramatically improve the lives of hundreds of millions of people.

3. Increased Focus on Neglected Tropical Diseases (NTDs)

• NTDs affect over 1 billion people globally
• Current annual research funding for NTDs is about $3 billion

Potential Impact: The current $3 billion could fund 15,000 clinical trials instead of just 30. This could potentially lead to treatments for all 20 WHO-recognized NTDs. It would improve the lives of over 1 billion people in developing countries.

4. Advancement in Personalized Medicine

• Reduced costs could allow for more targeted trials for specific genetic profiles
• Assuming 1% of new trials (5,000) focus on personalized treatments

Potential Impact: This could lead to thousands of new targeted therapies. These therapies could dramatically improve treatment efficacy. They could also reduce side effects for millions of patients.

5. Economic Benefits

Reduced Healthcare Costs:

• Assuming new treatments reduce healthcare costs by an average of $1,000 per patient per year
• If 10% of the global population (780 million people) benefit from new treatments

Potential Impact: Annual global healthcare savings of $780 billion

Economic Productivity Gains:

• Assuming improved health increases productivity by $2,000 per treated person per year
• For 780 million people benefiting from new treatments

Potential Impact: Annual global productivity gain of $1.56 trillion

6. Faster Response to Global Health Crises

• Ability to rapidly test multiple treatments for new diseases or pandemics
• If 1,000 trials could be launched within a month of a new outbreak

Potential Impact: Potentially saving millions of lives and trillions in economic losses by rapidly identifying effective treatments

7. Advancements in Preventive Medicine

• Increased ability to test preventive treatments and interventions
• If 5% of new trials (25,000) focus on prevention

Potential Impact: Could lead to breakthroughs in preventing major diseases like Alzheimer’s, diabetes, or various cancers, potentially adding billions of healthy years to global life expectancy

8. Reduced Animal Testing

• Lower costs could accelerate the development of alternatives to animal testing
• Assuming a 50% reduction in animal testing due to new methodologies

Potential Impact: Saving millions of animal lives annually while potentially improving the accuracy and speed of preclinical research

9. Democratization of Medical Research

• Lower costs could allow smaller institutions, developing countries, and even citizen scientists to conduct trials
• If 20% of new trials (100,000) come from previously underrepresented sources

Potential Impact: A more diverse approach to global health problems, potentially leading to breakthroughs in overlooked areas and reducing global health disparities

Conclusion

The potential benefits of reducing clinical trial costs from $100 million to $200,000 are staggering. We could see:

• A 500-fold increase in new treatments developed annually
• Treatments for the majority of rare diseases within a year
• Significant advancements in neglected tropical diseases, personalized medicine, and preventive care
• Global economic benefits potentially exceeding $2 trillion annually
• Faster responses to health crises, saving millions of lives
• A more democratic, diverse approach to medical research