Yale program now processing requests for Johnson & Johnson pharmaceutical clinical trial data
The Yale University Open Data Access (YODA) Project is now receiving and processing requests for pharmaceutical clinical trial research data provided by Janssen, the Pharmaceutical Companies of Johnson & Johnson. Requests can be directly submitted to the YODA Project through its new website.
As part of a January 2014 agreement between the YODA Project and Janssen, the YODA Project will act as a bridge between investigators and Janssen, with full jurisdiction to approve or deny requests from investigators for the de-identified data associated with the clinical trials executed by Janssen. This establishes a process in which all requests for clinical data submitted to Janssen are fairly judged and decided upon by the YODA Project, acting as an independent academic partner.
“What is important here is that Janssen has granted the YODA Project authority over the decisions regarding how to release the data and who to release them to,” said Dr. Harlan Krumholz, director of the YODA Project and the Harold H. Hines, Jr. Professor of Medicine (cardiology) at Yale School of Medicine. “Our goal is to promote the constructive use of these data for scientific purposes — and we will not consider it a success unless there has been important new knowledge generated as a result.”
Final policies and procedures to guide external investigators in their request for the data — which demonstrate the YODA Project’s guiding principles of data transparency and public health benefit — are available on the YODA Project website. In addition, requests for clinical trial data for recombinant human bone morphogenetic protein-2 (rhBMP-2; Infuse), made available by Medtronic, Inc., will also continue to be available online.
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