stuff #53
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… reference - Introduced a detailed technical specification document for the dFDA core platform, outlining technologies, architecture, and implementation details. - Created a reference document listing existing decentralized clinical trial platforms and vendors, highlighting their features and potential alignment with dFDA goals. - Both documents aim to provide foundational knowledge for engineers and stakeholders involved in the dFDA initiative.
- Updated the cost-benefit analysis document to provide a Rough Order of Magnitude (ROM) estimate for building and operating the dFDA core platform, including detailed assumptions and a breakdown of costs. - Enhanced the platform technical specification to reflect completed elaboration, including refined technology stack choices, security measures, and performance requirements. - Both documents aim to provide clearer guidance for stakeholders and technical teams involved in the dFDA initiative.
…tegy - Revised the funding section to provide a more accurate range for the total upfront costs of the dFDA initiative, now estimated between ~$50M and over $2.2 billion, depending on execution success. - Clarified the need for dedicated congressional appropriations for full-scale operation, emphasizing the financial challenges associated with the initiative. - This update aims to enhance understanding of the financial implications for stakeholders involved in the dFDA initiative.
…mplementation - Introduced a new document listing specific U.S. federal laws that could be modified or repealed to facilitate the dFDA initiative, focusing on reducing costs and time for new medical interventions. - Each law includes areas for review and potential modifications to align with the goals of decentralized clinical trials. - This addition aims to provide a clear legislative framework for stakeholders advocating for regulatory reform in support of the dFDA concept.
- Added detailed proposals for modifying existing regulations to streamline the certification and oversight of dFDA platforms, including pathways for third-party roles and international harmonization. - Introduced specific modifications aimed at simplifying informed consent processes, reducing GCP burdens, and maximizing the use of real-world evidence in regulatory decisions. - These enhancements aim to facilitate the adoption of decentralized clinical trials and improve regulatory efficiency in support of the dFDA initiative.
…ation - Introduced multiple new documents detailing specific regulatory modifications aimed at enhancing the dFDA initiative, including streamlined pathways for platform certification, informed consent adaptations, and integration of real-world evidence in regulatory processes. - Recommendations include leveraging platform capabilities for safety monitoring, data management, and compliance, as well as advocating for harmonization of international standards. - These additions aim to facilitate the adoption of decentralized clinical trials and improve regulatory efficiency, aligning with the overarching goals of the dFDA initiative.
Add regs modification documentation and Revise cost-benefit analysis and platform technical specification
…implementation - Introduced a new markdown metadata standard for consistency across documentation, ensuring all files include essential metadata fields. - Added multiple regulatory recommendations aimed at modernizing FDA regulations to facilitate decentralized clinical trials, including adaptations for informed consent, postmarket safety reporting, and pediatric protections. - Recommendations emphasize leveraging platform capabilities for data management, safety monitoring, and compliance, aligning with the goals of the dFDA initiative.
- Introduced multiple markdown documents detailing specific regulatory recommendations aimed at enhancing the dFDA initiative, including frameworks for integrating various processes such as informed consent modernization, remote facility inspections, and product liability clarifications. - Each document includes essential metadata for consistency and improved accessibility, aligning with the goals of the dFDA initiative to streamline regulatory processes and facilitate decentralized clinical trials. - These additions emphasize leveraging platform capabilities to enhance compliance, safety, and efficiency in the regulatory landscape.
…ment - Updated the dfda-cost-benefit-analysis.md file to ensure consistent formatting of monetary values and improve clarity throughout the document. - Adjusted various sections to maintain uniformity in the presentation of cost estimates, enhancing readability and comprehension for stakeholders. - These changes aim to provide a clearer understanding of the financial implications associated with the dFDA initiative.
- Introduced a new markdown document detailing the systemic issues preventing patient access to Alzheimer's clinical trials, highlighting the disconnect between available treatments and trial participation. - The document outlines key barriers such as geographic limitations, strict eligibility criteria, and bureaucratic inefficiencies, supported by quantitative data on patient access. - Emphasizes the need for a decentralized approach to clinical trials to improve patient enrollment and expedite treatment availability, aligning with the dFDA initiative's goals.
fixed latex equations
…entation - Updated the recovery-trial.md file to enhance the formatting of hyperlinks for cost per patient and other key statistics, ensuring a more cohesive presentation of information. - Clarified cost efficiency comparisons by providing authoritative sources for cost estimates, emphasizing the trial's dramatic cost-effectiveness relative to traditional clinical trials. - These changes aim to improve readability and support the dFDA initiative's goal of transparent and accessible clinical trial data.
fix: Improve hyperlink formatting and clarity in recovery trial
…ments and remove outdated sections
…e and efficiency benchmarks
docs: enhance referral rewards system documentation
1 percent treaty
…ing unnecessary fields and ensuring consistent formatting. Key files modified include 'cost-of-disease.md', 'cost-of-war.md', 'decentralized-institutes-of-health.md', and others, enhancing clarity and organization.
…ing related topics. Key updates include adding references to the 'cost of disease' and 'cost of war' in 'cost-of-disease.md', 'cost-of-war.md', and other related documents, improving navigation and context for readers.
…l progress, and necessity of reallocation markdown files. Key updates include linking to the '1% Treaty' and improving navigation for related topics, ensuring a cohesive understanding of the content.
…arkdown. Key updates include linking savings, ROI, life-years generated, health intervention status, and cost of inaction to relevant sections for improved navigation and context.
Enhance inter-document references in the DFDA cost-benefit analysis markdown. Key updates include linking savings, ROI, life-years generated, health intervention status, and cost of inaction to relevant sections for improved navigation and context.
…tHub profile and project links
…revent rendering issues
docs: add Markdown dollar sign escaping rule to prevent LaTeX render
…or improved readability
…nhanced citations and formatting for better readability
…md for clarity and accuracy
… improved sourcing, including revised citations and new sourcing standards
…fining cost estimates and outlining broader initiative expenses
…s and add new open-ecosystem-and-bounty-model.md to outline strategy for sustainable development
…aths and chemical additives
docs: simplify UpdateElementStyle function calls in diagrams
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Reviewer's GuideThis PR refines language and data descriptions in home.md for clarity, adds supporting blockquote citations for key claims, and introduces a related CSV asset file. File-Level Changes
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Summary by Sourcery
Refine home.md copy for clarity, update key statistics and citations, and add a supporting CSV asset.
Documentation:
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