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_quarto-dfda-impact.yml
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project:
type: website
output-dir: _site/dfda-impact
execute-dir: project
resources:
- knowledge/data/
- assets/
- _redirects
- robots.txt
- llms.txt
render:
# Paper is copied to index.qmd by render script
- index.qmd
- knowledge/appendix/parameters-and-calculations.qmd
- knowledge/appendix/economist-feedback-dfda.qmd
# Custom fields for render-quarto.py
dih-render:
emoji: "💊"
index-source: knowledge/appendix/dfda-impact-paper.qmd
fallback-404-redirect-domain: https://manual.WarOnDisease.org # Redirects here if path doesn't exist on this site
pdf-output-file: dfda-impact-paper.pdf
netlify-site-id: "a314a33e-3155-4067-8624-706266899419"
netlify-cname: "impact-dfda-earth.netlify.app"
show-confidence-intervals: true # Show 95% CI ranges for calculated values in academic papers
concept-terms:
- term: "Ubiquitous Pragmatic Trial Impact Analysis"
manual-target: knowledge/solution/dfda.qmd
aliases:
- "dFDA Impact Analysis"
# Image generation prompts (used by scripts/images/generate-project-branding-images.ts)
favicon-prompt: "A pill or capsule with an upward impact arrow."
profiles:
default:
dotenv:
allowEmptyValues: true
author:
- name: Mike P. Sinn
email: m@warondisease.org
orcid: 0009-0006-0212-1094
affiliations:
- name: "Institute for Accelerated Medicine"
url: https://acceleratedmedicine.org
website:
title: "Ubiquitous Pragmatic Trial Impact Analysis: How to Prevent a Year of Death and Suffering for 84 Cents"
description: 'Only 15 diseases/year get their first treatment each year. With 6.65 thousand diseases lacking effective treatments, the backlog would take 443 years to clear. Integrating pragmatic trials into standard healthcare increases trial capacity 12.3x, cutting that timeline from 443 years to 36 years. The average untreated disease gets a treatment 212 years earlier, saving 10.7 billion deaths at $0.842 per year of healthy life saved.'
site-url: https://manual.warondisease.org/knowledge/appendix/dfda-impact-paper.html
favicon: assets/icons/dfda-favicon.png
page-navigation: true
page-footer:
left: "© 2025 [Institute for Accelerated Medicine](https://acceleratedmedicine.org) | [CC BY-NC 4.0](https://creativecommons.org/licenses/by-nc/4.0/)"
center: "[PDF](https://manual.warondisease.org/knowledge/appendix/dfda-impact-paper.pdf) | [All Papers](https://manual.warondisease.org/knowledge/papers.html)"
right: "[VOTE](https://WarOnDisease.org)"
navbar:
right:
- text: "dFDA Spec"
href: https://dfda-spec.warondisease.org
- text: "Prototype"
href: https://dfda.earth
- text: "Economist Review"
href: knowledge/appendix/economist-feedback-dfda.qmd
- text: "Calculations"
href: knowledge/appendix/parameters-and-calculations.qmd
- text: "VOTE"
href: https://WarOnDisease.org
execute:
fig-path: "knowledge/figures/"
cache: false
freeze: auto # Only re-run cells when content changes
daemon: 300
daemon-restart: false
env:
PYTHONPATH: "."
metadata:
importance: 98
creator: "Mike P. Sinn"
orcid: "0009-0006-0212-1094"
primary-author: "Mike P. Sinn"
byline: "Mike P. Sinn"
human-author: "Mike P. Sinn"
author-email: "mike@warondisease.org"
author-url: "https://mikesinn.com"
author-website: "https://mikesinn.com"
contact: "mike@warondisease.org"
language: "en-US"
subject: "Health Economics, Cost-Benefit Analysis, ROI, Clinical Trials, Drug Development"
category: "Academic Paper, Health Economics, Policy Analysis"
coi-statement: "The author declares no competing interests, unless you count a vested interest in not dying, which the author shares with approximately 8 billion co-conspirators."
data-availability: "All data and code used in this analysis are publicly available at https://github.com/wishonia/earth-optimization-protocol"
ethics-statement: "This research did not involve human subjects. The 6,650 diseases with zero FDA-approved treatments were not consulted, as they were busy not being treated."
funding: "This research received no funding. The author would like to note that the cost of producing the entire paper was roughly 84 cents per hour of work, which is coincidentally also the cost per DALY it proposes to achieve."
github-profile: "https://github.com/mikepsinn"
linkedin: "https://www.linkedin.com/in/mikesinn"
orcid-url: "https://orcid.org/0009-0006-0212-1094"
google-scholar: "https://scholar.google.com/citations?user=RjDd_qcAAAAJ"
keywords:
- dfda
- cost-benefit-analysis
- roi
- return-on-investment
- clinical-trials
- drug-development
- health-economics
- pragmatic-trials
- recovery-trial
- real-world-evidence
- regulatory-efficiency
- decentralized-fda
version: "0.9"
edition: "Working Draft"
copyright: "© 2025 The Institute for Accelerated Medicine"
copyright-year: "2025"
license: "CC BY-NC 4.0"
license-url: "https://creativecommons.org/licenses/by-nc/4.0/"
rights: "Creative Commons Attribution-NonCommercial 4.0 International License"
publisher: "Institute for Accelerated Medicine"
publisher-url: "https://acceleratedmedicine.org"
publisher-name: "Mike P. Sinn"
publisher-email: "mike@warondisease.org"
repo-url: "https://github.com/wishonia/earth-optimization-protocol"
issue-url: "https://github.com/wishonia/earth-optimization-protocol/issues"
source-url: "https://github.com/wishonia/earth-optimization-protocol"
geographic-coverage: "Global"
audience: "Policy Makers, Health Economists, Regulatory Scientists, Investors, Healthcare Administrators"
format: "Working Paper"
type: "Academic"
genre: "Health Economics, Policy Analysis, Cost-Benefit Analysis"
medium: "Digital"
twitter-site: "https://x.com/warondisease"
twitter-creator: "https://x.com/warondisease"
og-site-name: "The Health and Economic Impact of a Global System for Pragmatic Clinical Trials"
# Identifiers
# Zenodo Concept DOI (stable across all versions - use for citations and new versions)
doi: "10.5281/zenodo.18243914"
# Open Graph metadata (enables per-page custom OG images)
open-graph: true
image: "https://manual.warondisease.org/assets/og/dfda-impact-og-1200x630.jpg"
# Publication tracking
publishing:
own-site:
url: "https://manual.warondisease.org/knowledge/appendix/dfda-impact-paper.html"
status: deployed
preprints:
- platform: zenodo
status: auto-uploaded
url: "https://zenodo.org/record/18522032"
doi: "10.5281/zenodo.18243914"
- platform: medrxiv
status: pending
url: ""
- platform: ssrn
status: pending
url: ""
journals:
- name: "Value in Health"
tier: 2
status: target
url: ""
- name: "Health Affairs"
tier: 1
status: target
url: ""
- name: "PharmacoEconomics"
tier: 2
status: target
url: ""
# Remove "Appendix" prefix
language:
crossref-apx-prefix: ""
section-title-appendices: ""
# Bibliography: Single source of truth for all citations
bibliography: references.bib
csl: nature-annotated.csl # Renders 'abstract' field (quotes) in bibliography
jupyter: dih-project-kernel
format:
html:
lightbox: auto
theme:
- cosmo
mermaid:
theme: neutral
echo: false
number-sections: true
toc: true
toc-depth: 3
css:
- styles.css
- economics-overrides.css
include-before-body:
- file: assets/html/page-loader.html
include-after-body:
- file: assets/html/site-enhancements-loader.html
include-in-footer:
- file: assets/html/generated-footer.html
include-in-header:
- text: |
<!-- Icons (project-specific) -->
<link rel="icon" type="image/png" sizes="32x32" href="/assets/icons/dfda-favicon-32x32.png">
<link rel="icon" type="image/png" sizes="16x16" href="/assets/icons/dfda-favicon-16x16.png">
<link rel="apple-touch-icon" sizes="180x180" href="/assets/icons/dfda-apple-touch-icon.png">
<link rel="icon" type="image/png" sizes="192x192" href="/assets/icons/dfda-android-chrome-192x192.png">
<link rel="icon" type="image/png" sizes="512x512" href="/assets/icons/dfda-android-chrome-512x512.png">
- file: assets/html/google-analytics.html
- file: assets/html/hypothesis.html
- file: assets/html/fonts-preload.html
citation-hover: true
code-fold: true
link-citations: true
smooth-scroll: true
code-tools: false
filters: [assets/filters/live-version-note.lua]
pdf:
output-file: "dfda-impact-paper.pdf"
documentclass: article
institute: "Institute for Accelerated Medicine"
echo: false
toc: true
toc-depth: 3
number-sections: true
colorlinks: true
link-citations: true
date: ""
include-in-header:
- callout-bw.tex
- institute-header.tex
- text: |
\paperurl{https://manual.warondisease.org/knowledge/appendix/dfda-impact-paper.html}
geometry:
- top=1in
- bottom=1in
- left=1in
- right=1in
fontsize: 11pt
filters: [assets/filters/live-version-note.lua]