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Yale to enable J&J to share its device, diagnostics clinical data with external researchers

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Improved access by researchers to corporate clinical trial data, much like open-source software, is expected to help facilitate a conversation between academia and the business world that could both facilitate translational research and help to validate corporate research. Yale University and Johnson & Johnson ($JNJ) have announced the first such deal to enable external investigator access to medical device and diagnostics clinical data from J&J.

The medical conglomerate will allow investigators access to its clinical trial data in those businesses, as well as for pharmaceuticals, via the Yale University Open Data Access (YODA) Project, which will sit as an independent intermediary that manages investigator requests and facilitates access to the data. The deal includes access to data across the company, including all relevant J&J business.

The deal is an expansion upon a previous data sharing deal from last year that was combined just to the drug business of J&J.

"Sharing data from clinical trials leads to greater insights in medicine," Dr. Joanne Waldstreicher, chief medical officer of Johnson & Johnson said in a statement. "This agreement with the YODA Project underscores Johnson & Johnson's commitment to responsibly share clinical trial data with researchers in a way that we believe advances medical science and public health."

The news coincides with the release of a report on clinical data sharing from the nonprofit Institute of Medicine, which is the health-focused arm of the National Academy of Sciences. It aims to offer guidance on how corporations can share their clinical data, which was created with the cooperation of 23 public and private companies. The IOM report offers best-practices for fairly sharing clinical data without exposing personal details about the trial participants.

The Yale-J&J deal allows YODA to approve or deny requests from investigators for de-identified patient data associated from clinical trials conducted by J&J companies. Requests to access the data can be made by researchers through the YODA site. The expectation is that that the arrangement could provide a model that could help spur more data sharing by companies.

"This action will benefit society and represents a major step forward in the effort to promote data sharing, as Johnson & Johnson's leadership in this area now extends from sharing its drug data to sharing its device and diagnostics data," Dr. Harlan Krumholz, professor of medicine and leader of the YODA Project, said in a statement. "We hope this action serves as a catalyst to others to join the momentum on open science."

- here is the release from Yale University
- and the Institute of Medicine report
- as well as coverage from The New York Times and Bloomberg

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