|Johnson & Johnson's headquarters in New Brunswick, NJ--Courtesy of J&J|
Johnson & Johnson ($JNJ) is the latest Big Pharma company that has vowed to open its clinical trial data vaults to the public. Going a step further than previous efforts, it's enlisting the help of Yale University to manage data requests.
Under an agreement with the Yale School of Medicine, the school's Open Data Access (YODA) Project will serve as an independent body to oversee requests from investigators and physicians looking to access anonymized clinical trial data from J&J's Janssen. YODA, not J&J, will review each request and make final decisions on data sharing. Members of the YODA team will select and appoint an independent external panel of non-Janssen experts to help in some cases to assess requests.
GlaxoSmithKline ($GSK), Roche ($RHHBY), Pfizer ($PFE) all have begun rolling out trial data in some capacity. But J&J's decision is an unprecedented move in the push toward open-access clinical trials data because it's the first industry-academic model of its kind.
J&J's move comes on the heels of Sanofi's ($SNY) declaration earlier this month to join the open-access movement. Sanofi said it will provide data, documents and reports on studies used to back up U.S. and European applications on drugs approved after the first day of 2014.
It's likely no coincidence that J&J and Sanofi's announcements come just after the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America's Jan. 1 adoption of joint principles on data sharing. The EMA has delayed its final policy on transparency until March.
"Sharing anonymized data from clinical trials is critical to advance public health because it furthers our understanding of diseases, expands the base of knowledge needed to develop new treatments, and generates new insights and more complete evidence to enable better healthcare decisions for patients--all while protecting patient privacy and confidentiality," said Dr. Joanne Waldstreicher, J&J's chief medical officer, in a statement. "We are pleased to collaborate with YODA to ensure that each and every request for access to our pharmaceutical clinical data is reviewed objectively and independently. This represents a new standard for responsible, independent clinical data sharing."
With the announcement also comes a new web tool launched by Janssen to make it easier for researchers to request access to trial data.
In a company statement, J&J and Janssen expressed support for PhRMA-EFPIA's principles of greater clinical trial data transparency and sharing, including registration and disclosure of clinical trial results in external registries, publication of results in peer-reviewed journals, and sharing of Clinical Study Reports.
- read the J&J announcement