Yale Open Data Access (YODA) – J&J Collaboration with Yale
*Jeffrey Gardner, Janssen R&D 

Keywords: sharing clinical trial data

The responsible sharing of clinical trial data with researchers external to the sponsor company requires a balance between maintaining patient privacy and researcher access to data. Janssen has partnered with the Yale Open Data Access project to help balance these two elements. There are three basic components to responsible data sharing. Request Intake: The first is the collection of the researcher’s request which includes identification of clinical trials and proposed analysis plans. The YODA project website allows researchers globally to request access to Janssen clinical trial data. Request Evaluation: Each request received is reviewed for completeness and evaluated for merit with respect to advancing public health knowledge. The independent evaluation is performed by the YODA project which has access to a steering committee for guidance. Janssen is blinded to the identity of the requester until the request is approved/declined and posted on the YODA project website. Requests to support commercialization or litigation are outside of the scope of the YODA project. Request Fulfillment: The sharing of patient level data (PLD) is provided in the form of a safe harbor certified analysis platform. Researchers are granted access to requested trial data and have a variety of analysis tools available to perform their research. PLD and analysis output remain within the platform until the researcher is ready to publish their results.