CardioExchange Archive

In a major victory for advocates of open access to data from clinical trials, Johnson & Johnson today announced that it will make all of its clinical trial data available to outside researchers. The company said that the Yale University Open Data Access (YODA) Project will serve as an independent third party “to review requests from investigators and physicians seeking access to anonymized clinical trials data.”

The company said that this program “is the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data.” Last year Glaxo SmithKline and Pfizer announced that they would share clinical trial data, but the full extent of their commitment is still unclear and they have not arranged for an independent third party to review requests for data. Through its arrangement with YODA, J&J appears to have made a more substantial commitment to sharing its data. Other pharmaceutical and device companies will now undoubtedly face increased pressure to share their data as well.

“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, leader of the YODA Project and CardioExchange Editor-in-Chief, in a Yale press release. “By establishing this fair and independent process to release data, Johnson & Johnson has taken a leadership position in this emerging era of open science.”

“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 Joanne Waldstreicher, J&J’s Chief Medical Officer. YODA, she said, will “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.”

In its announcement J&J said it would first make data available from Janssen, its pharmaceutical unit. But the company said it was “also committed to sharing data from clinical trials of its medical device and consumer products.”

In addition to Yale’s YODA, the AllTrials.Net project in the U.K. has been a major force in advocating for open data from clinical trials.