Janssen, the Pharmaceutical Companies of Johnson & Johnson
The Yale University Open Data Access (YODA) Project is now embracing its next challenge and has entered an agreement with Janssen Pharmaceuticals that will enable scientists across the world to gain access to the company’s clinical trial data assets. The goal is to balance data availability with an intention to promote strong scientific research and serve the public good. This effort will accelerate the movement of the clinical research enterprise toward more cooperative learning and sharing.
The YODA Project performs independent scientific reviews of investigator requests for Janssen’s clinical trial data, including both Clinical Study Reports and participant-level data. There are several potential notable aspects of this new collaboration. First, Janssen has conferred on the YODA Project the authority to make decisions about the release of their clinical trial data. This truly establishes an independent process in which requests are fairly judged and decisions are made by an independent academic partner. Another notable aspect of the agreement is the scope. Janssen is beginning this initiative by making clinical trial data for pharmaceutical products available, with the goal of expanding the effort in the future to include medical devices and consumer products. Finally, this initiative reviews requests for all products currently available on the market, not only products developed in 2014 and beyond. This is a remarkable step forward in the continuing evolution of open science in clinical medicine.
Current Project Status
Over the past 6 months, the YODA Project has been working to establish the Policy and Procedures to Guide External Investigator Access to Clinical Trial Data, with input from stakeholders. These documents have been finalized after a period of public comment and are now posted on the YODA Project website. The YODA Project seeks to continually improve these policies and, accordingly, may modify them in the future. The YODA Project is currently working to build a data request website through which applications for data will be processed.
The YODA Project anticipates beginning to process requests for Janssen’s clinical trial data in late Summer 2014.