NEW HAVEN, Conn. — Pharmaceutical giant Johnson & Johnson has announced that it will be the first medical device manufacturer to share its clinical data for device and diagnostics as part of the Yale University Open Data Access Project (YODA).
While the company already shares such information with regards to its pharmaceutical products, it will now share with YODA clinical trial data on all of its devices. While a competing device manufacturer has shared such data with the YODA project for a single medical device, J&J plans to share the clinical data for all of its devices and diagnostics.
Purpose of Clinical Trial Data
Clinical trial data is used by companies to evaluate the effectiveness and safety of a product. Up until recently, such information was guarded and considered proprietary information by the companies.
However, push back from the public and the larger medical community has resulted in a shift in thinking – especially in light of recalls and health complications caused by FDA-approved medical devices and drugs.
The European Medicines Agency now requires the publication of clinical data as part of its application process for new drugs, as of January 1, 2015.
The policy change reflects the larger regulatory community’s desire to improve transparency. J&J’s announcement occurred on the same day as the release of the Institute of Medicine’s report recommending major changes in the industry’s sharing of medical studies and adverse events.
By allowing for this information to be accessible to others, it will hopefully lead to greater product safety and accountability. The YODA Project is trying to aid in this effort by collecting all of the previously unavailable data, and not only increasing the availability of information, but increasing its use as well. By collecting clinical data, researchers at YODA can act as a third-party reviewer of information for physicians, investigators, and the public.
Why is this important? This may potentially mean that researchers and doctors can spot trends in defective medical devices, and identify safety concerns and other possible health complications across multiple manufacturers’ product lines.
In the meantime, however, safety will remain a concern with medical products. Patients harmed by dangerous medical products need experienced attorneys who can fight to win them just compensation.
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