Medical Device Clinical Trial Data from Johnson & Johnson To Be Made Available

| Printer friendly version

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.




Leave a Reply

By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.