YODA - sporedata/researchdesigneR GitHub Wiki

• The Yale Open Data Access (YODA) Project is an initiative designed to promote transparency and accessibility in clinical research by providing access to clinical trial data. Established in 2011, the YODA Project is a pioneer in creating a platform for independent reviews and data sharing, setting a standard for responsible conduct in clinical research. The project aims to facilitate the sharing of clinical trial data between academic, government, and industry partners to enhance transparency, accelerate the use and dissemination of clinical trial data, and facilitate the sharing of clinical research data to promote scientific discovery, improve public health.

• The YODA Project employs a structured approach to data sharing, offering raw, de-identified clinical trial datasets and protocols at no cost for approved requests. This standardization promotes transparency and encourages broader use of clinical trial data. The YODA Project's policies ensure that data use proposals are publicly available, promoting an open science environment.

• Researchers must adhere to stringent compliance requirements, including IRB approval and a conflict of interest disclosure. All data use proposals that undergo thorough review by clinical investigators and blinded reviews by data partners. The YODA Project also provides standardized Data Use Agreements (DUAs) to streamline the approval process.

• Quality assurance is a key focus, with protocols ensuring that data are reliable and appropriately prepared for research use. Researchers are prohibited from redistributing or publicly posting the data outside the YODA platform.

The YODA Project facilitates access to a wide array of clinical trial data, supporting various research activities, including:

• Safety Evaluations: Investigating adverse events and long-term safety of medical products.
• Clinical Outcomes Research: Analyzing the effectiveness of treatments and interventions.
• Comparative Effectiveness Research: Comparing the effectiveness of different treatments.

• Selective Data Sharing: Promotes transparency by requiring the publication of all approved data use proposals.
• Costs of Data Procurement: The YODA Project provides data at no cost to approved researchers.
• Incentives for Data Sharing: Encourages data sharing by engaging a broad array of stakeholders and promoting the responsible conduct of research.

• Standardized Datasets: Provides raw, de-identified clinical trial data in a standardized format.
• Stakeholder Engagement: Involves a multi-stakeholder advisory group to develop policies and procedures.
• Transparency Initiatives: Publishes all data use proposals and abstracts of results on the YODA website.

The YODA Project includes diverse data variables, such as:

• Clinical Data: Baseline characteristics, treatment details, outcomes, etc.
• Adverse Events: Data on any adverse events reported during the clinical trials.
• Laboratory Results: Blood tests, imaging results, etc.
• Demographic Information: Age, gender, ethnicity, etc.

• Data Preparation: Does not accommodate custom data requests, such as imaging data.
• Data Integration: Challenges due to variability in data formats and standards.
• Privacy Concerns: Ensures strict adherence to privacy regulations like GDPR and CCPA.
• Access Restrictions: Requires compliance with regulatory standards and IRB approval.

• Advancing Science: By providing access to a rich repository of clinical trial data, the YODA Project enables researchers to conduct secondary analyses, validate original study findings, and explore new research questions.
• Improving Public Health: The data shared through the project can inform public health decisions, contribute to the development of new treatments, and improve clinical practices.
• Fostering Collaboration: The project fosters collaboration between academic researchers, industry, and public health organizations, promoting a more collaborative and open scientific community.

• Data Privacy and Security: Ensuring the privacy and security of shared data is a critical concern. The YODA Project employs stringent measures to protect sensitive information and comply with data protection regulations.
• Intellectual Property and Commercial Interests: Balancing the interests of data holders, who may have concerns about intellectual property and commercial implications, with the goal of promoting open data access can be challenging.

The YODA Project represents a significant effort to enhance the transparency and accessibility of clinical research data, ultimately contributing to the advancement of medical knowledge and the improvement of patient care.

• YODA Project Overview
• Straight talk with...Harlan Krumholz
• Yale University Open Data Access Project (YODA)
• The Yale Open Data Access (YODA) Project - Sharing Health Data
• Overview and experience of the YODA Project with clinical trial data sharing after 5 years
• Relapse in clinically stable adult patients with schizophrenia or schizoaffective disorder: evidence-based criteria derived by equipercentile linking and diagnostic test accuracy meta-analysis

Academic institutions and research entities can access YODA datasets by following institutional protocols and agreements, including obtaining IRB approval and accepting YODA's terms of use.

Researchers must submit an online application, including a research proposal, conflict of interest disclosure, and completion of a training video on the Data Use Agreement (DUA). Access to data is contingent upon signing a DUA, with specific terms designed to ensure responsible data use.

• YODA Project Application Process
• Data Use Agreement Training

[1] Grossmann C, Chua PS, Ahmed M, Greene SM. Sharing Health Data: The Why, the Will, and the Way Forward. 2023.

[2] Grossmann C, Chua PS, Ahmed M, Greene SM. CASE STUDY: The Yale Open Data Access (YODA) Project - Sharing Health Data. National Academies Press (US). 2022.