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PUBLIC RELEASE DATE:
30-Jan-2014

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Contact: Karen N. Peart
karen.peart@yale.edu
203-432-1326
Yale University

Yale program's agreement with Johnson & Johnson allows broad access to clinical trial data

In a move that promotes open science, the Yale University Open Data Access (YODA) Project has entered an agreement with Johnson & Johnson that will enable scientists around the world to gain access to the company's clinical trial data assets.

This partnership establishes an independent process that promotes data sharing and leverages prior research investments to produce new knowledge. The program will start with the release of pharmaceutical trial data, followed by subsequent availability of data from clinical trials of medical devices and consumer products.

The Yale University Open Data Access (YODA) Project within the Yale-New Haven Hospital Center for Outcomes Research and Evaluation (CORE) will perform an independent scientific review of investigator requests. Johnson & Johnson will participate in developing the principles of scientific review. The company has ceded to YODA all decision-making authority over the release of the data. This establishes a process in which all requests for clinical data submitted to the company are fairly judged and decided upon by an independent academic partner.

"This is a remarkable action by Johnson & Johnson that should accelerate the movement of the clinical research enterprise toward more cooperative learning and sharing," said Harlan Krumholz, M.D., director of the YODA Project and the Harold H. Hines, Jr. Professor of Medicine (cardiology) at Yale School of Medicine. "By establishing this fair and independent process to release data, Johnson & Johnson has taken a leadership position in this emerging era of open science."

Researchers will be able to submit proposals to use data from studies of products that are being sold. The data will be free of charge and do not have information that can identify individuals. Submitted proposals will be posted publicly and registered at clinicaltrials.gov. The investigators will assume the responsibility of reporting their results.

This partnership is part of the larger YODA mission to promote scientific inquiry and lower barriers to data access. The YODA Project is rooted in the view that patients, providers, and industry will be better informed when academic investigators are able to facilitate the independent assessment and dissemination of data relevant to the benefits and harms of industry products. These assessments will allow physicians and patients to base their decisions on the most comprehensive and contemporary evidence available.

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