Health care giant Johnson & Johnson (J&J) is the first device-maker to agree to broadly share clinical trial data for its medical devices and diagnostics with a medical school.
J&J struck a deal with the Yale University Open Data Access (YODA) Project to make results from its clinical trials of its Medical Devices and Diagnostics business available to researchers. The YODA Project, launched in 2011, operates a third-party independent reviewer of requests from investigators and physicians who want access to data from clinical trials. This establishes a fully independent intermediary to manage requests and promote data use.
J&J already provides clinical trial data to the YODA Project for its pharmaceutical products. An expanded scope of medical devices and diagnostics is another step forward in the expansion of data sharing in the continuing evolution of open science in clinical medicine.
The announcement came on the same day that the Institute of Medicine (IOM) called on sponsors of clinical trials to share study data with outside researchers within 6 months after journal publication and all data no later than 18 months after the last patient visit in the trial. The IOM released a 249-page report, which sets out several steps that clinical trial sponsors are encouraged to take to widen access to data.
“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,” said Harlan Krumholz, professor of medicine and leader of the YODA Project. “We hope this action serves as a catalyst to others to join the momentum on open science.”
Previously, device maker Medtronic allowed Yale to evaluate data on a controversial spinal treatment, known as Infuse, however J&J is the first company to make its medical diagnostics and devices data available in a systemic way. Researchers used available clinical data for Medtronic’s Infusion through the YODA Project and found that the produced offered little or no benefit compared with alternatives.
For years industry denied sharing its research externally in fear that the move would expose trade secrets and claiming that it would violate patient privacy. But the shift towards open science in clinical medicine continues.
Some have expressed their disappointment that J&J’s agreement does not include most products that are already on the market because it only applies to products that have been approved since start of last year. Additionally, since the US Food and Drug Administration (FDA) does not require all medical devices to go through clinical trials prior to approval, the available data for these devices will be limited.
“Sharing data from clinical trials leads to greater insights in medicine. This agreement with the YODA Project underscores Johnson & Johnson’s commitment to responsibly share clinical data with researchers in a way that we believe advances medical science and public health,” said Dr. Joanne Waldstreicher, chief medical officer of Johnson & Johnson.
In an effort to provide access to data, the European Medicines Agency (EMA) implemented a new policy to publish clinical data submitted as part of marketing applications for drugs.
Source: Yale University