Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available
According to MedicalXpress, expansive data from a company’s medical device clinical trials will soon be made broadly available to medical device researchers for the first time. The Yale University Open Data Access (“YODA”) Project will make data from certain Johnson & Johnson (“J&J”) businesses available to outside researchers. YODA will act as an independent gatekeeper to access the data.
Previously, only pharmaceutical data from J&J was available through the YODA program. Under the extended program that now includes data related to medical devices and diagnostics, clinical trial results from the Medical Devices and Diagnostics divisions of J&J will be made available. As with the J&J pharmaceutical data requests, YODA will review the requests for device/diagnostic patient data, which has been sanitized of patient identifying information. However, the agreement only covers products approved since early 2014 and thus excludes many products currently on the market. One device for which data will be available is J&J’s Thermocool Smarttouch catheter, a device used to treat atrial fibrillation that received approval in 2014 .
YODA launched in 2011. According to the YODA website, the Project
“advocates for the responsible sharing of clinical research data” and “is committed to open science and data transparency, and supports research attempting to produce concrete benefits to patients, the medical community, and society as a whole.”
Medical device giant Medtronic, Inc. has also partnered with YODA, albeit currently only with regard to Medtronic’s recombinant human bone morphogenetic protein-2 (rhBMP-2) data. Medtronic has previously shared medical device clinical trial data with the YODA Project for a single product, a bone formation product called “Infuse.” Given J&J’s expansion of its available data, other industry leaders, such as Medtronic, may well follow suit and make available additional data.
More information about the YODA project is available here, including a listing of available clinical trial data and how to make a request. An FAQ on the YODA project is also available here.
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