Johnson & Johnson, one of the world's largest medical-device manufacturers, will start sharing clinical trial data for its devices and diagnostics, making it the first devicemaker to broadly share such data with a medical school.
The New Brunswick, N.J.-based healthcare company already shares clinical trial data for its pharmaceutical products with the Yale University Open Data Access (YODA) Project and will now begin providing access to the same data for its devices and diagnostics. The YODA Project, which launched in 2011, operates as a third-party independent reviewer of requests from investigators and physicians who want access to clinical trial data.
“Through sharing of clinical trial data for medical devices, we can now learn more about these important medical treatments,” Dr. Joseph Ross, associate professor of medicine and member of the YODA Project, said in a statement.
The announcement was made Wednesday, the same day that the Institute of Medicine issued a report recommending major changes in how the results of medical studies are shared, including analyzable data sets and timetables for communicating adverse event summaries.
In recent years the medical community has become much more critical about the proprietary nature of clinical trial data, which can be used to further evaluate the effectiveness and safety of medical products after they have been approved by the Food and Drug Administration. Manufacturers traditionally do not provide access to clinical trial data for their products but changes are underway by both regulators and industry to improve sharing of clinical trial data.
Johnson & Johnson's device and diagnostics business has generated about 37% of the company's total revenue so far this year. The company sells a wide range of medical devices, including orthopedic implants, common surgical supplies such as sutures and staplers, and diabetes products.
But in recent years Johnson & Johnson has faced questions about its safety reputation as well as the loss of billions of dollars due to recalls and lawsuits filed by patients who had been treated with company devices such as its metal-on-metal hip implant system, power morcellators and vaginal mesh devices.
Medtronic, another large medical-device manufacturer, was the first devicemaker to share clinical trial data about a medical device with the YODA Project. That 2011 effort was limited to clinical trial data for one product, a bone formation product called Infuse. Using clinical data made available through the YODA Project, researchers in 2013 found that Infuse offered little or no benefit compared with alternatives.
The way that drugs and medical devices gain approval from the Food and Drug Administration differ, and devices tend to come to market with “much less robust evidence at the time of approval,” said Dr. Harlan Krumholz, a Yale cardiologist.
“These devices, however, are playing a growing role in medical care and it is increasingly important that we have a thorough understanding of the evidence that does exist,” he added.
The medical community in recent years has become much more critical about the proprietary nature of clinical trial data. Manufacturers traditionally do not provide access to clinical trial data for their products but changes are underway by both regulators and industry to address sharing of clinical trial data.
A new policy implemented by the European Medicines Agency to publish clinical data submitted as part of marketing applications for drugs went into effect Jan. 1. GlaxoSmithKline launched a similar effort that allows researchers to request patient data collected in clinical trials for its products. Ten other drug manufacturers are also providing access to the website.
The Yoda project has received four requests for Medtronic's data on Infuse and eight requests for Johnson & Johnson's clinical trial data for its pharmaceutical products so far, a Yale spokeswoman said in an e-mail.
Follow Jaimy Lee on Twitter: @MHjlee
