- Johnson & Johnson (J&J) has announced that it will share data from its drug, device and diagnostic trials.
- For many years, open-access advocates have demanded greater access to the clinical trial data that drug companies generate as part of their research; however, much of that data has remained unavailable.
- The Institute of Medicine (IOM) has also released a report stating that investigators should be required to establish a data-sharing plan when the trial is initiated and that all clinical trial data should be available no later than 18 months after the last patient visit. The report also states that data underlying a trial analysis should be available six months after publication.
For years, researchers have been clamoring for access to clinical trial generated during pharmaceutical clinical trials, but that data has been viewed as proprietary. In a blog post from Forbes, Larry Husten examined viewpoints from several advocates to understand how the perspective on clinical data sharing is changing. Overall, advocates consider clinical trial data "a shared community resource" rather than private property. Moreover, the patients in the clinical trials are providing a service by taking on risk and they deserve to have the results of their efforts shared with the scientific world.
While the IOM report is not binding and does not dictate policy, it will undoubtedly influence the zeitgeist, especially as large companies like J&J set an example by opening up their data vaults to the world.