This document provides the detailed technical implementation plan for the decentralized FDA (dFDA) platform. It is a component of the higher-level strategic plan detailed in the Canonical Roadmap, which covers the political and financial strategy for funding the DIH and, subsequently, this technical build.
Below is an absurdly comprehensive, highly-detailed, hierarchical to-do list for launching a global decentralized trial system with AI coordination, robust patient rights (trial participation, importation), and universal data-sharing standards. The goal is to move as quickly and cheaply as possible, though some tasks inevitably require large investments. Time and cost estimates are approximate and can vary widely based on execution, political climate, and scope. Recommended organizations and experts are illustrative suggestions based on known capabilities.
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Ship Minimal Governance + Automation
1.1. Stand up Contracts and Oracles
- Tasks: Deploy minimal treasury, QF, bounties, subsidies; evidence/identity/safety oracle MVPs.
- Time: 4–8 weeks
- Cost: $50k–150k (audit + infra)
- Personnel: 3–5 smart contract + 1–2 data engineers
1.2. Autogenerate Mission Metrics
- Tasks: Encode KPIs; compute OKRs from events/data; publish public dashboards.
- Time: 2–3 weeks
- Cost: $5k–10k
- Personnel: 1 data eng, 1 product
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Secure Initial Funding Commitments
2.1. Pitch to Philanthropists / Foundations
- Tasks: Prepare pitch decks, ROI arguments, and philanthropic impact statements.
- Time: 2–3 months
- Cost: $20k–50k (travel, materials)
- Potential Funders:
- Gates Foundation, Chan Zuckerberg Initiative, Open Philanthropy, Wellcome Trust
2.2. Engage High-Net-Worth Individuals
- Tasks: Host focused briefings with performance dashboards and live contract demos.
- Time: 1–2 months (overlap)
- Cost: $10k–30k
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Tech & AI Architecture Blueprint
3.1. Evaluate Existing Decentralized Trial Components
- Tasks: Compare open-source modules and DCT APIs; prefer bounty integration over vendor lock-in.
- Time: 1–2 months
- Cost: $20k–40k
3.2. Draft AI Agent Specs
- Tasks: Design trial design/monitoring/fraud/triage agents with audit logs and safety hooks.
- Time: 2–3 months
- Cost: $50k–100k
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Launch Bounty-Driven Pilot
1.1. Open Bounties Instead of RFPs
- Tasks: Publish specs and acceptance tests; pay on merge/deploy.
- Time: 2–4 weeks
- Cost: $100k–300k for milestone bounties
- Potential Contributors: Existing DCT platforms and open-source teams
1.2. Build/Customize Platform for Pilot
- Tasks: Integrate eConsent, real-time data capture, and safety pause; instrument evidence oracle outputs.
- Time: 4–6 months
- Cost: $2M–5M
- Personnel: 20–40 engineers and data scientists
1.3. Run Real-World Pilot Trials
- Tasks: Recruit patients, gather outcomes, ensure safety via automated incident scoring.
- Time: 6–12 months (overlaps)
- Cost: $2M–5M
- Sites: Remote-first; partner clinics as needed
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AI Coordination Agent MVP
2.1. Assemble AI Dev Team
- Tasks: Recruit 10–20 data scientists, NLP specialists, compliance experts.
- Time: 2–3 months
- Cost: $2M–4M/yr in salaries + $1M–2M for computing resources
- Possible Partners: Microsoft, OpenAI, or a specialized AI startup
2.2. Train Initial Model
- Tasks: Collect datasets on clinical trial protocols, regulations, legislative processes.
- Time: 3–5 months
- Cost: $2M–5M for data acquisition, computational overhead
2.3. Prototype Global Policy Negotiation
- Tasks: Test AI agent's ability to draft policy proposals, identify shared interests among stakeholders, propose compromise language.
- Time: 2–4 months
- Cost: $1M–2M for pilot testing, feedback loops with actual stakeholders
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Interstate Compact Feasibility & Drafting
3.1. Lobby Key States
- Tasks: Work with 2–3 receptive states (e.g., CA, TX, NY) to draft Cure Zone language.
- Time: 3–6 months
- Cost: $500k–1M in targeted lobbying, legal drafting
3.2. Form State-Level Coalition
- Tasks: Convene local patient advocacy groups, healthcare associations, and legislators.
- Time: Overlaps with lobbying (3–6 months)
- Cost: $100k–200k for events, workshops
- Organizations: NCSL, local chapters of American Medical Association
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Public Awareness and Signature Collection
- Description: Execute a multi-channel strategy to gather signatures from 1% of the global population.
- Tasks: National public awareness initiatives, social media, influencer endorsements emphasizing patient empowerment.
- Success Metrics:
- 80 million+ signatures collected.
- Sustained media presence.
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Lobbying Effort
- Description: Engage professional firms and build grassroots support to advocate for the 1% Treaty with key governments, starting with the U.S.
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AI Agent Integration with Policy-Making
3.1. Beta-Test AI with Regulators
- Tasks: Deploy AI agent in limited scenarios with FDA, EMA, TGA for streamlined rulemaking.
- Time: 4–6 months
- Cost: $2M–5M
- Personnel: AI specialists, government liaisons
3.2. Global Coordination
- Tasks: Extend AI agent to negotiate cross-border data-sharing and reciprocal approvals with EMA, TGA, PMDA.
- Time: 6–12 months
- Cost: $10M–20M (travel, legal harmonization, pilot cooperation)
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Expansion of Pilot Trials & Infrastructure
4.1. Scaling the Decentralized Platform
- Tasks: Integrate additional disease areas (cardiology, neurology), ramp up patient recruitment.
- Time: Ongoing throughout Phase 2
- Cost: $50M–100M
- Partners: Hospitals, academic research centers worldwide
4.2. Validate Economic & Clinical Impact
- Tasks: Gather cost-effectiveness data, health outcomes, patient satisfaction metrics to bolster legislative arguments.
- Time: 6–12 months of data analysis
- Cost: $5M–10M
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Major Prize Launch ($200–300M)
1.1. Design Prize Criteria
- Tasks: Reward solutions enabling frictionless cross-border trials, data privacy compliance, robust patient rights integration.
- Time: 2–3 months to finalize criteria
- Cost: $500k–1M for administration
- Organizations: XPRIZE Foundation (could administer the competition), philanthropic consortia
1.2. Marketing & Global Outreach
- Tasks: Launch global media campaign, partner with WHO, large charities.
- Time: 6–12 months
- Cost: $20M–30M (events, marketing, staff)
1.3. Evaluation & Award
- Tasks: Independent judging panel from academic, regulatory, and patient communities.
- Time: 12–24 months to see final solutions tested
- Cost: $200–300M prize pool (only awarded upon success)
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AI Agent as Global Negotiator
2.1. Full Deployment
- Tasks: Make AI agent accessible to all governments, patient groups, and trial sponsors for real-time policy negotiation.
- Time: 12–24 months (overlapping with prize competition)
- Cost: $30M–50M for scaling infrastructure, language expansions, 24/7 support
2.2. Institutionalize Governance
- Tasks: Form an international oversight body to ensure AI ethics, safety, and fairness.
- Time: 6–12 months
- Cost: $5M–10M
- Suggested Entities: WHO, a newly formed nonprofit (Global Cure Governance Council)
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Finalizing Federal & Interstate Compact Integration
3.1. Ratify Federal Legislation
- Tasks: Ensure final passage of a bill mandating decentralized trials, broadening Right to Try, establishing import pathways.
- Time: Could align with end of the 5th year if momentum is strong
- Cost: Incorporated into earlier lobbying budgets
3.2. State Adoption
- Tasks: Remaining states join the Cure Zone compact or default to federal law.
- Time: 12–18 months post-federal law
- Cost: $10M–20M in additional outreach (if needed)
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Global Governance & Reciprocal Approvals
1.1. Harmonize with EMA, TGA, PMDA
- Tasks: Continued AI-led negotiations to unify approval processes.
- Time: Ongoing for years 5–10
- Cost: $5M–15M annually
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Maintenance & Continuous Improvement
2.1. Platform & AI Upgrades
- Tasks: Regular software updates, new features (telehealth improvements, advanced analytics), cybersecurity.
- Cost: $10M–20M/year
2.2. Ethics & Equity Initiatives
- Tasks: Ensure global access for low-income regions, address bias in AI.
- Cost: $5M–15M/year
- Partners: WHO, philanthropic organizations (Gates Foundation, PATH, UNICEF)
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Ongoing Data Collection & Outcome Measurement
3.1. Epidemiological & Cost-Savings Reports
- Tasks: Publish annual updates on patient outcomes, cost reductions, new cures discovered.
- Cost: $1M–2M/year (analysis, report publication)
3.2. Public Engagement
- Tasks: Annual summits, open data portals for patients and researchers.
- Cost: $2M–5M/year
¶ ESTIMATED GRAND TOTAL (5–8 Years)
- Phase 0: ~$250k–350k
- Phase 1: ~$20M–40M (pilot platform + AI MVP + preliminary lobbying)
- Phase 2: ~$100M–200M (scaling platform, stronger lobbying, partial AI integration)
- Phase 3: ~$250M–400M+ (prize pool, global AI rollout, final legislative push)
- Phase 4: $10M–40M/year ongoing for governance, updates, expansions
Overall: ~$400M–$700M+ through Year 5 (not including the Prize awards if we treat them as a separate fund). Long-term sustainability might add $20M–$60M annually.
- Philanthropy & Funding:
- Gates Foundation, Chan Zuckerberg Initiative, Open Philanthropy, Wellcome Trust
- Policy & Lobbying:
- Major lobbying firms (Brownstein Hyatt, Akin Gump)
- Nonprofits (Patients Rising, Global Genes, American Cancer Society)
- AI Development & Research:
- OpenAI, Anthropic, Microsoft Research, Google DeepMind
- Decentralized Trial Platforms:
- Science 37, Medable, Curebase, THREAD
- Legal & Regulatory Experts:
- Hogan Lovells, Covington & Burling, Sidley Austin (Healthcare practices)
- Former FDA Commissioners (e.g., Scott Gottlieb as consultant)
- Global Policy Bodies:
- WHO, EMA, TGA, PMDA, National Conference of State Legislatures (NCSL)
This absurdly comprehensive breakdown shows the massive coordination required—technically, politically, and financially—to build a truly global decentralized trial system with guaranteed patient rights. While the numbers and timelines are large, strategic partnerships, focused advocacy, a well-managed AI agent, and an eventual prize competition could unify stakeholders and fast-track a future where everyone has immediate access to life-saving treatments.