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79 changes: 79 additions & 0 deletions docs/contributing.md
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# Contributing The Decentralized FDA (dFDA)

## For Non-Technical Users:

1. **Editing Documentation via GitHub's Online Editor**:
- Navigate to the file you want to edit in your forked repository on GitHub.
- Click on the pencil icon (Edit this file) in the top right corner of the file view.
- Make your changes in the editor.
- At the bottom of the page, describe your changes and click **Commit changes**.

2. **Using GitHub Issues and Discussions**:
- Navigate to the **Issues** or **Discussions** tab in the main [dFDA repository](https://github.com/decentralized-fda/decentralized-fda).
- You can create a new issue/discussion or contribute to an existing one.

## For Developers and Technical Users:

1. **Code Contributions**:
- After cloning your fork, create a new branch for your contribution.
- Make your changes in this branch.
- Once you're done, push the branch to your fork and submit a pull request.

2. **Pull Requests**:
- Make sure your code follows the project's coding standards.
- Write a clear description in your pull request explaining your changes.
- Link any relevant issues in the pull request description.

## Review Process

1. **Community Voting**:
- The community reviews pull requests.
- Everyone is encouraged to vote with a thumbs up (👍) or thumbs down (👎) on pull requests.
- Pull requests with more thumbs-up votes will be considered favorably.

2. **Automated Merging**:
- A GitHub Action is set up to automatically merge pull requests that have a positive thumbs-up count after 24 hours.
- Make sure to address any feedback or changes requested by the community.

## Final Steps

After your pull request is merged, your contributions will be part of the Decentralized FDA project. We encourage you to keep participating, share your experience with others, and help us grow this initiative.

# Other Ways to Contribute

If you already have organizations or project aligned with the goals of the Decentralized FDA (dFDA), you can contribute in several valuable ways. Here are some suggestions:

### 1. Partnership and Collaboration
- **Integrate Existing Projects**: If your project or organization has tools, datasets, or services that align with the dFDA's objectives, consider integrating them into the dFDA ecosystem.
- **Joint Ventures**: Engage in collaborative projects that leverage the strengths of both your organization and the dFDA.
- **Data Sharing Agreements**: If you're a data silo owner, consider forming partnerships to share non-sensitive or anonymized data, respecting privacy and regulatory constraints.

### 2. Data Contribution and Management
- **Contribute Data**: Share relevant data, especially if it can fill gaps in the dFDA's current dataset. This could include clinical data, research findings, or real-world health data.
- **Data Standardization**: Help in developing or adopting standards for data formatting and sharing to ensure compatibility and interoperability.
- **Data Governance**: Assist in establishing guidelines and policies for data management, privacy, and security.

### 3. Technical and Knowledge Contributions
- **Develop Interoperable Solutions**: If your organization has expertise in creating healthcare software, consider developing applications or tools that are compatible with the dFDA's framework.
- **Expertise Sharing**: Offer your expertise in areas like medical research, data analysis, AI, blockchain, etc., to improve the dFDA's strategies and methodologies.
- **Documentation and Training**: Contribute to educational materials, guides, or training programs to help users understand and engage with the dFDA platform and its components.

### 4. Advocacy and Community Engagement
- **Promote the Vision**: Use your organization's platform to advocate for the dFDA's goals and encourage others to participate.
- **Host Events and Workshops**: Organize events, webinars, or workshops to educate about the dFDA's mission and how others can contribute.
- **Community Building**: Help in building a community of like-minded organizations and individuals to foster a collaborative environment.

### 5. Financial and Resource Support
- **Sponsorship and Funding**: Provide financial support, either through direct funding or by helping to secure grants and other forms of financial assistance.
- **Resource Allocation**: Offer resources like server space, software licenses, or access to professional networks that can assist the dFDA project.

### 6. Policy and Regulatory Guidance
- **Regulatory Expertise**: Offer guidance on navigating the complex regulatory landscapes related to healthcare data and interventions.
- **Policy Development**: Assist in developing policies and best practices that promote open collaboration while ensuring compliance with legal and ethical standards.

### 7. Public and Institutional Liaison
- **Liaise with Public Health Bodies**: Act as a bridge between the dFDA and public health institutions, regulatory bodies, and NGOs.
- **Stakeholder Engagement**: Engage with various stakeholders, including patients, healthcare providers, and policymakers, to ensure the dFDA's solutions meet diverse needs.

Collaboration, knowledge sharing, and strategic partnerships will be key to this effort.

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# ✏️ Contributing to Documentation

A **Pull Request** (PR) is a method used on GitHub to suggest changes to a repository (a place where code is stored). It's like saying, "I've made some changes; please review them and add them to the main project if they're good."

When you submit a PR, you're asking the repository maintainers to review your changes and merge them into the main codebase if they agree with your modifications.

## Why Submit a Pull Request?

- **Contribute to a Project**: If you find a typo, a bug, or see an opportunity for improvement, a pull request lets you contribute your changes.
- **Collaborate with Others**: PRs allow you to discuss your changes with project maintainers and collaborate to refine your contribution.

## How to Submit a Pull Request

### Step 1: Find the File You Want to Edit
- Navigate to the repository where you want to make a change.
- Find the file you want to edit. It could be a code file, a README, or any other document in the repository.

### Step 2: Edit the File
- Click on the file in the repository.
- To edit the file, click the pencil icon (🖉) in the top right corner of the file view.
- Make your changes in the online editor.

### Step 3: Propose Your Changes
- After making changes, scroll down to the bottom of the page.
- Enter a title and description for your changes in the provided fields. Be as clear as possible about what you changed and why.
- Click **Propose file change**.

### Step 4: Create the Pull Request
- After proposing your file change, you'll be taken to a new page titled "Comparing changes".
- Review your changes to ensure they are correct.
- Click the green **Create pull request** button.
- Add any additional comments about your changes, then click **Create pull request** again.

### Step 5: Wait for Review
- Once you've submitted the PR, the project maintainers will review it.
- You might receive comments or questions about your changes.
- If the maintainers approve your changes, they will merge them into the project. If not, they may ask for further modifications or explain why the changes can't be merged.
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# CureDAO Monorepo

The goal of this monorepo is to acheive maximum interoperability and minimum duplication of effort between the various projects in the digital health ecosystem.
The goal of this monorepo is to achieve maximum interoperability and minimum duplication of effort between the various projects in the digital health ecosystem.

## Why a monorepo?

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---
title: 💊 The Decentralized FDA 🌎
description: A global federation to help the FDA and global regulatory agencies quantify the effects of millions of factors like foods, drugs, and supplements affect human health.
description: A global federation to help regulatory agencies by quantifying the effects of millions of factors like foods, drugs, and supplements affect human health and happiness.
---

# 💊 The Decentralized FDA 🌎

A global federation to help the FDA and global regulatory agencies quantify the effects of millions of factors like foods, drugs, and supplements affect human health.

🤝 **Join Us**: Whether you're a developer, researcher, health professional, regulatory, or simply passionate about health innovation, your contribution can make a monumental difference!

<details>
<summary>🚧 WORK IN PROGRESS</summary>
[👉 Tell Us About Your Project!](#)

# 🛟 Help Wanted!

Contributions are eternally appreciated!
Code or documentation improvements are eternally appreciated!

It's our goal to avoid any duplication of effort. So please include existing projects that would be interested in fulfilling any part of this global framework.
</details>
<br>

**[👉 Click Here to Contribute](contributing.md)**

# 😕 Why are we doing this?

The current system of clinical research, diagnosis, and treatment is miserably failing the billions of people are suffering from chronic diseases.

<details>
<summary>👉 Click to learn more about why it sucks... </summary>

It takes over [10 years and 2.6 billion dollars](https://www.semanticscholar.org/paper/Innovation-in-the-pharmaceutical-industry%3A-New-of-DiMasiGrabowski/3275f31c072ac11c6ca7a5260bd535720f07df41) to bring a drug to market (including failed attempts).
It costs [$41k](https://www.clinicalleader.com/doc/getting-a-handle-on-clinical-trial-costs-0001) per subject in Phase III clinical trials.

The high costs lead to:

⚛️ **1. No Data on Unpatentable Molecules**

We still know next to nothing about the long-term effects of 99.9% of the 4 pounds of over [7,000](https://www.dailymail.co.uk/health/article-8757191/Are-additives-food-making-ill.html) different synthetic or natural compounds. This is because there's only sufficient incentive to research patentable molecules.

![chemicals-in-our-diet.svg](images/chemicals-in-our-diet.svg)

🤑 **2. Lack of Incentive to Discover Every Application of Off-Patent Treatments**

Thousands of drugs were found to work for other diseases after the patent expired. Unfortunately, there isn't financial incentive to do any more research on them at this point.

📆 **3. No Long-Term Outcome Data**

It's not financially feasible to collect a participant's data for years or decades. Thus, we don't know if the long-term effects of a drug are worse than the initial benefits.

🤐 **4. Negative Results Aren't Published**

Pharmaceutical companies tend to only report "positive" results. That leads to other companies wasting money repeating research on the same dead ends.

🎯 **5. Trials Exclude a Vast Majority of The Population**

One investigation found that only [14.5%](https://www.ncbi.nlm.nih.gov/pubmed/14628985) of patients with major depressive disorder fulfilled eligibility requirements for enrollment in an antidepressant trial. Furthermore, most patient sample sizes are very small and sometimes include only 20 people.


🤏 **6. We Only Know 0.000000002% of What is Left to be Researched**

We've only studied [0.000000002%](https://www.centerwatch.com/articles/12702-new-mit-study-puts-clinical-research-success-rate-at-14-percent) of the [166 billion](https://www.nature.com/articles/549445a) potential medicinal molecules.

![studied-molecules-chart-no-background.svg](images/studied-molecules-chart-no-background.svg)
</details>
👉 [Click to learn more about why it sucks...](stuff-that-sucks.md)

# 🧪 Our Hypothesis

Expand Down Expand Up @@ -104,79 +69,62 @@ We don't want to reinvent the wheel in any way, so if there's an existing projec

![dfda-gateway-api-node-silo.png](components/data-silo-gateway-api-nodes/dfda-gateway-api-node-silo.png)

dFDA Gateway API Nodes make it easy for data silos, such as hospitals and digital health apps, to let people export and save their data locally in their [PersonalFDA Nodes](#2-personalfda-nodes).
[dFDA Gateway API Nodes](components/data-silo-gateway-api-nodes) should make it easy for data silos, such as hospitals and digital health apps, to let people export and save their data locally in their [PersonalFDA Nodes](#2-personalfda-nodes).

**👉 [Learn More About Gateway APIs](components/data-silo-gateway-api-nodes/data-silo-api-gateways.md)**

## 2. PersonalFDA Nodes

PersonalFDA Nodes are applications that can run on your phone or computer. They import, store, and analyze your data to identify how various factors affect your health. They can also be used to share anonymous analytical results with the [Clinipedia dFDA Wiki](#3-clinipediathe-wikipedia-of-clinical-research) in a secure and privacy-preserving manner.
[PersonalFDA Nodes](components/personal-fda-nodes/personal-fda-nodes.md) are applications that can run on your phone or computer. They import, store, and analyze your data to identify how various factors affect your health. They can also be used to share anonymous analytical results with the [Clinipedia dFDA Wiki](#3-clinipediathe-wikipedia-of-clinical-research) in a secure and privacy-preserving manner.

[PersonalFDA Nodes](components/personal-fda-nodes/personal-fda-nodes.md) are composed of two components, a [Digital Twin Safe](components/personal-fda-nodes/digital-twin-safe/digital-twin-safe.md) and a [personal AI agent](components/personal-fda-nodes/data-analysis/optimiton-ai-agent/optomitron-ai-agent.md) applies causal inference algorithms to estimate how various factors affect your health.

### 2.1. Digital Twin Safes

PersonalFDA Nodes are composed of two components, a Digital Twin Safe and an AI agent called Optimitron (or some better name) that uses causal inference to estimate how various factors affect your health.
![digital-twin-safe-no-text.png](components/personal-fda-nodes/digital-twin-safe/digital-twin-safe-no-text.png)

### 2.1. Digital Twin Safe

![digital-twin-safe-cover.png](components/personal-fda-nodes/digital-twin-safe/digital-twin-safe-cover.png)

A local application for self-sovereign import and storage of personal data.

**👉[Learn More or Contribute to Digital Twin Safe](components/personal-fda-nodes/digital-twin-safe/digital-twin-safe.md)**

### 2.2. Optimitron AI Agent
### 2.2. Personal AI Agents

Optimitron is an AI agent that lives in your PersonalFDA node that uses causal inference to estimate how various factors affect your health.
[Personal AI agents](components/personal-fda-nodes/data-analysis/optimiton-ai-agent/optomitron-ai-agent.md) that live in your [PersonalFDA nodes](components/personal-fda-nodes/personal-fda-nodes.md) and use [causal inference](components/personal-fda-nodes/data-analysis/optimiton-ai-agent/optomitron-ai-agent.md) to estimate how various factors affect your health.

![data-import-and-analysis.gif](images/data-import-and-analysis.gif)
[![data-import-and-analysis.gif](images/data-import-and-analysis.gif)](components/personal-fda-nodes/data-analysis/optimiton-ai-agent/optomitron-ai-agent.md)

**👉[Learn More About Optimitron](components/personal-fda-nodes/data-analysis/optimiton-ai-agent/optomitron-ai-agent.md)**


## 3. Clinipedia—The Wikipedia of Clinical Research

![clinipedia_globe_circle.png](components/clinipedia/clinipedia_globe_circle.png)
[![clinipedia_globe_circle.png](components/clinipedia/clinipedia_globe_circle.png)](components/clinipedia/clinipedia.md)

The Clinipedia wiki should be a global knowledge repository containing the aggregate of all available data on the effects of every food, drug, supplement, and medical intervention on human health.
The [Clinipedia wiki](components/clinipedia/clinipedia.md) should be a global knowledge repository containing the aggregate of all available data on the effects of every food, drug, supplement, and medical intervention on human health.

![outcome-labels.png](components/personal-fda-nodes/data-analysis/outcome-labels/outcome-labels.png)
**[👉 Learn More or Contribute to the Clinipedia](components/clinipedia/clinipedia.md)**

### Tentative Requirements
- Editing Authorization and Conflict Resolution Mechanisms
- AI Agent Generated Meta-Analyses Combining All Existing Research on Each Intervention/Outcome Pair
- Directory of Data Silos and Instructions for Individuals to Export Their Data to their Digital Twin Safes
- Inter-Jurisdictional Comparative Policy Analysis of the Outcomes of Regulatory Decisions
- Outcome Labels List the Degree to Which the Product is Likely to Improve or Worsen Specific Health Outcomes or Symptoms
- Certification of Intervention Manufacturers/Sources
- Intervention Effectiveness Ranking for Specific Outcomes or Conditions
- Decentralized Clinical Trial Coordination and Protocols
### 3.1 Outcome Labels

**[👉 Learn More or Contribute to the Clinipedia](components/clinipedia/clinipedia.md)**
A key component of Clinipedia are [**Outcome Labels**](components/personal-fda-nodes/data-analysis/outcome-labels/outcome-labels.md) that list the degree to which the product is likely to improve or worsen specific health outcomes or symptoms.

![outcome-labels.png](components/personal-fda-nodes/data-analysis/outcome-labels/outcome-labels.png)

**👉 [Learn More About Outcome Labels](components/personal-fda-nodes/data-analysis/outcome-labels/outcome-labels.md)**

# AI Collective Intelligence Platform
# Human-AI Collective Intelligence Platform

A collective intelligence coordination platform is needed for facilitating cooperation, communication, and collaborative actions among contributors.

## Desired Features
**[👉 Learn More or Contribute to the dFDA Collaboration Framework](components/human-ai-collective-intelligence-platform/dfda-collaboration-framework.md)**

1. Communication Channels
2. Resource Sharing Mechanisms
3. Decentralized Collaborative Workspaces
4. Partnership Agreements
5. Project Management
6. Knowledge Repository
7. Legal and Regulatory Guidance
8. Impact Tracking
9. Reputation Scoring
# Roadmap

**[👉 Learn More or Contribute to the dFDA Collaboration Framework](components/human-ai-collective-intelligence-platform/dfda-collaboration-framework.md)**
We'd love your help and input in determining an optimal roadmap for this project.

# To-Do List
**[👉 Click Here for a Detailed Roadmap](roadmap.md)**

1. Establish Foundation
2. Build Board of Directors
3. Establish Collaborations and Partnerships
4. Data Silo Gateway API Nodes
5. PersonalFDA Nodes
6. Clinipedia dFDA Wiki

**[👉 Click Here for a Detailed Roadmap and Milestones](roadmap.md)**

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