The company is working with Yale School of Medicine’s Open Data Access (YODA) Project, handing over raw, anonymized data from its pharmaceutical trials to investigators and researchers vetted by YODA’s independent reviewers. J&J will provide data from trials of medical devices, pharmaceuticals and consumer products from its entire family of companies, including studies that have never been published.
"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," J&J chief medical officer Dr. Joanne Waldstreicher said in prepared remarks. "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."
The YODA team will work with J&J on the research requests, but final decisions will be left to YODA, which will act as an independent body collaborating with the healthcare giant. The project has also spawned its own website, where researchers can request data.
"We already have well established policies for registration and disclosure of clinical trial results in external registries as well as publication of results in peer reviewed journals, and we have historically worked with external researchers to address other types of data requests," according to Dr. Bill Hait, global head of research & development for Janssen, the pharmaceutical family of J&J companies. "We are delighted that through agreement with YODA, we will now be able to share data from our clinical trials in the form of Clinical Study Reports (CSRs) and participant level data in a systematic and objective way that advances medicine and scientific knowledge while protecting patient privacy and confidentiality."
Privacy concerns have long dogged clinical trial transparency efforts, but a series of recent scandals and recalls have made openness a high priority. Publicly available registries for clinical data have become routine in recent years, largely due to a 2007 FDA amendment that mandated publication on ClinicalTrials.gov, but there are loopholes that have allowed some groups to keep their data and results private, according to a 2012 editorial published in the New England Journal of Medicine.
Author Dr. Jeffrey Drazen voiced support for the Trial and Experimental Studies Transparency (TEST) Act, sponsored by Rep. Edward Markey (D-Mass.), which would have expanded reporting requirements for clinical trials. That bill was referred to the Subcommittee on Health in May 2013, and no Roll Call votes have been scheduled so far.
"We can make progress in medicine only if people are willing to put themselves at risk to test new diagnostic and therapeutic approaches," Dr. Drazen said in his editorial. "To recognize and reward these participants, and in keeping with the Declaration of Helsinki, clinical trials should be conducted in the open, with full public knowledge of the question asked, the intervention tested, and the results obtained."
J&J’s open-data move has won accolades from around the healthcare industry, with one Forbes article calling it a "stunning win for open science," but some aren’t ready to lavish praise just yet. The proof will be in the pudding, Sage Bionetworks CEO Stephen Friend, former a Merck executive, told Xconomy.
"I don’t think not possible to express enthusiasm, beyond a general sense, for something without 1st understanding the criteria by which people are going to say ‘I’ll agree, or not agree’ to make something public,’" Friend told the news source.