YODA Project — Yale Open Data Access

Overview

The Yale University Open Data Access (YODA) Project is an independent academic initiative housed at Yale School of Medicine that facilitates responsible sharing of individual participant-level clinical trial data. Founded in 2013, YODA operates as a trusted third-party intermediary between industry data holders and external researchers, taking full jurisdiction over data access decisions and removing conflicts of interest from the data sharing process. As of 2024, 499 trials are available, predominantly pharmaceutical and medical device trials from partners including Johnson and Johnson and SI-BONE, with approximately 385 access requests processed at a roughly 95% approval rate. All requests and decisions are publicly posted for transparency.

Model and Scope

YODA’s distinguishing feature is independent jurisdiction: data partners contractually transfer full decision-making authority to YODA, so the project rather than the data owner grants or denies access. Approved researchers access data alongside protocols, analysis plans, and clinical study reports in a secure enclave. Conflict of interest disclosure is required and a Data Use Agreement is signed prior to access.

Policy Influence

YODA provided proof of concept that large-scale clinical trial data sharing is feasible at scale without disrupting pharmaceutical operations, influencing industry attitudes toward data sharing. Its model informed the NIH Data Sharing Policy strengthening enacted in 2023, which requires all NIH-funded investigators to share data.

Connections

• relatedTo: VIVLI (complementary clinical trial data sharing platform)
• relatedTo: TransCelerate (pharmaceutical industry data sharing initiative with aligned goals for clinical trial data access)

Resources

• https://yoda.yale.edu
• https://yoda.yale.edu/about/policies-procedures/
• https://doi.org/10.1038/sdata2018268 (five-year overview, Scientific Data)