Appendix X โ ๐ dFDA ROI: 463:1 Trial Efficiency
The 463:1 Return
The dFDA Infrastructure costs $40 million per year to run. It saves the world $50 billion per year in clinical trial costs. Thatโs a 463:1 return on investment.
Hereโs how.
The Math: From $41,000 to $500 Per Patient
Traditional Phase III trials cost $40,000-120,000 per patient. Mountains of paperwork. Armies of monitors. Years of delays.
The Oxford RECOVERY trial proved we can do the same thing for $500 per patient. They tested COVID treatments on 40,000+ patients by:
- Using existing hospital staff
- Collecting data electronically
- Focusing on what actually matters: does the patient live or die?
The dFDA takes this model global. 80-160x cost reduction. Same quality data. Better real-world applicability.
Where the $50 Billion Comes From
Global clinical trial spending: $100 billion per year (and growing).
Conservative estimate: dFDA captures 50% efficiency gains across the market.
- 50% of $100B = $50B saved annually
Optimistic scenarios show up to 95% cost reduction (like RECOVERY achieved), potentially saving $95B annually.
What $50 Billion Buys You
With the money saved every year, we could:
- Fund 10,000 new trials (at $5M each using efficient methods)
- Test treatments for 7,000 rare diseases currently ignored
- Cut drug development time from 17 years to 3-5 years
- Make medicines affordable by eliminating $2.2B development costs
Daily Opportunity Cost
Every day we donโt implement this:
- $137 million wasted on inefficient trials
- 2,301 QALYs lost to delayed treatments
- Countless patients denied access to potentially life-saving trials
The Platform Cost Breakdown
Annual Operating Costs: ~$40M
- Cloud infrastructure: $15M
- Engineering team (20 FTEs): $4-6M
- Compliance & security: $1M
- Global integration: $10M
- Ecosystem development: $10M
Upfront Build Cost: ~$40M (one-time)
- 2.5 years development
- 75 engineers
- Global infrastructure setup
ROI Scenarios
| Scenario | Annual Cost | Annual Savings | ROI Ratio | 10-Year NPV |
|---|---|---|---|---|
| Best Case | $11M | $95B | 2,577:1 | $495B |
| Base Case | $40M | $50B | 463:1 | $249B |
| Conservative | $60M | $30B | 250:1 | $190B |
| Worst Case | $270M | $30B | 66:1 | $50B |
Even in the absolute worst case, we get 66x returns.
Why This Isnโt Happening Already
Simple: The people getting rich from the current system arenโt the ones paying for it.
- CROs make billions from inefficiency
- Regulators protect their bureaucratic empires
- Pharma passes costs to patients anyway
- Patients have no power to change the system
Until now. The dFDA changes the game by aligning incentives: everyone profits from efficiency.
The Bottom Line
$40 million to save $50 billion. 463:1 ROI. 80x cost reduction per patient. 10,000x more trials possible.
This isnโt a moonshot. The RECOVERY trial already proved it works. We just need to scale it globally.
Every day we wait costs $137 million and 2,301 lives.
For detailed economic analysis and interactive charts, see dFDA ROI Analysis Charts
Sources: Original analysis from dfda-cost-benefit-analysis.md, RECOVERY trial data, Fortune Business Insights clinical trials market report 2024