J&J hands Yale the keys to its clinical trial data vault

Over the past year, GlaxoSmithKline ($GSK), Pfizer ($PFE) and Roche ($RHHBY) have each taken steps to open up their clinical trial data, but each has faced criticism for leaving loopholes in their policies. Johnson & Johnson ($JNJ) has now gone one step further by taking itself out of data-sharing decisions completely.

Instead of approaching J&J to request access to data, researchers will go through Yale University. J&J is simply handing over decision-making authority to Yale and allowing the university to share data from as far back as its records go. "They are sharing their entire trove of clinical trial data assets and they have given us complete authority and jurisdiction over all decisions regarding data access," Harlan Krumholz, head of the Yale Open Data Access Project (YODA), told The Wall Street Journal. "That's a remarkable action."

By giving Yale the keys to its data vaults, J&J has sidestepped one of the common criticisms of earlier transparency initiatives. Roche's policy was called "pathetic" by British charity Sense About Science, in part because data-access requests are handled by a panel appointed and overseen by the Swiss drugmaker. GSK also appoints a panel of independent experts to handle requests but has spoken of its desire to see data from multiple drugmakers collated in one system under the oversight of a third party. J&J's agreement with Yale could provide the basis for such a system.

Observers still have some concerns though. Stephen Friend, CEO of open-science project Sage Bionetworks, told Xconomy the value of the project will depend on the criteria used to judge requests to access data. While Yale will make the decision, if it is working from restrictive criteria, data will remain locked away. Technical shortcomings could also hold back the project, with Ben Goldacre, leader of the AllTrials transparency campaign, questioning how far back digital records go. If all the data from 5 years ago is on paper or floppy disks it will be of limited use to researchers.

Nonetheless, J&J is still adopting a policy that is too radical for some of its peers. The vision of a single, independent biopharma data warehouse appears a long way from being realized. "I have talked to other companies about this approach. There's a lot of resistance or reluctance," Yale's Krumholz said.

- read the WSJ article (sub. req.)
- here's Xconomy's piece
- check out Bloomberg's take
- and J&J's press release

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