The Yale University Open Data Access (YODA) Project is announcing the first-ever broad availability of clinical trial data for medical devices and diagnostics by a company. This historic expansion of data sharing is made possible through collaboration with Johnson & Johnson.
In this groundbreaking move, results from the clinical trails of the Medical Devices and Diagnostics businesses of Johnson & Johnson will be made available to researchers through an agreement with the Yale YODA Project. This establishes a fully independent intermediary to manage requests and promote data use, just as it has done with its pharmaceutical clinical trial data.
The YODA Project will continue to act as a bridge between investigators and Johnson & Johnson's pharmaceutical and device and diagnostics businesses. Under the arrangement, the YODA Project will approve or deny requests from investigators for de-identified patient data associated with the pharmaceutical, medical device, and diagnostic clinical trials conducted by Johnson & Johnson companies. This expanded scope that now includes device and diagnostic studies is another step forward in the continuing evolution of open science in clinical medicine.
"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 Dr. 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."
Dr. Joseph Ross, associate professor of medicine and member of the YODA Project, added, "Data sharing maximizes knowledge generation from clinical research studies, enabling multiple investigators to use the data for additional research projects. Through sharing of clinical trial data for medical devices, we can now learn more about these important medical treatments."
Dr. Joanne Waldstreicher, chief medial officer of Johnson & Johnson said, "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 trial data with researchers in a way that we believe advances medical science and public health."
Requests for data may be directly submitted to the YODA Project through its website.
Explore further: Safety review of bone growth product ushers in new era of data sharing