The clinical trial data transparency movement was propelled forward by two major developments this week. On the same day, influential national academy the Institute of Medicine (IOM) called for more systematic sharing of trial results and Johnson & Johnson ($JNJ) agreed to extend its transparency initiative to include medical devices and diagnostics.
J&J has again turned to the Yale University Open Data Access (YODA) project to facilitate its data-sharing plan. YODA and J&J teamed up one year ago to share data from clinical trials of drugs--a deal that was widely heralded as one of the most progressive in the industry--and are now extending their collaboration to include medical devices and diagnostics. J&J is effectively handling the keys to its data vault to YODA, which will decide whether to accept or reject researchers' requests for access.
The arrangement sees J&J relinquish a greater degree of control over its data than many of its peers have been willing to do, but some still have questions and concerns about the level of openness. How receptive YODA is to requests will partly depend on the criteria on which it bases its decisions. "The devil is always in the details on this stuff," National Center for Health Research President Diana Zuckerman told The New York Times. The exclusion of devices approved before 2014 is also a concern.
J&J has said it will consider requests for data from older devices, but these are outside of the terms of the current YODA agreement. Even with these caveats, the extension of YODA to include device data marks another big step forward for the transparency agenda. The movement gained a high-profile backer this week when the IOM--one of the National Academies--published a report on the sharing of clinical trial data.
The IOM concluded that the benefits of sharing outweigh the risks, but also noted technical barriers to realizing these gains. A lack of platforms to store and manage trial data--as well as problems finding, searching and linking these resources--topped the list of challenges identified by IOM.
- read the IOM summary (PDF)
- here's the NYT article
- check out NEJM 's piece
- and the YODA release