The Yale University Open Data Access (YODA) Project has announced the first-ever broad availability of clinical trial data for consumer products by a company. This expansion of data sharing is made possible through a collaboration with Johnson & Johnson.
Results from the clinical trials of the consumer businesses of Johnson & Johnson Consumer Companies will now be made available to researchers through an agreement with the YODA Project, establishing a fully independent intermediary to manage requests and promote data use, just as the company has done with its pharmaceutical and medical devices and diagnostic clinical trial data.
This expanded scope that now includes consumer studies is yet another step forward in the continuing evolution of open science in clinical medicine, say the YODA leaders. This partnership is part of the larger YODA mission to promote scientific inquiry and lower barriers to data access.
The YODA Project, which has partnered with three industry organizations to make clinical trial data available, will continue to act as an independent, unbiased bridge between investigators and clinical data from Johnson & Johnson’s pharmaceutical, medical devices, and consumer businesses. Under the arrangement, the YODA Project will approve or deny requests from investigators for de-identified patient-level data associated with the pharmaceutical, medical devices, and consumer clinical trials conducted by Johnson & Johnson companies.
“This represents another example of Johnson & Johnson’s leadership in open science and data sharing; no major company has a more progressive policy,” said Dr. Harlan Krumholz, director of the YODA Project and the Harold H. Hines, Jr. Professor of Medicine (cardiology) at the Yale School of Medicine.
The YODA Project is rooted in the view that patients, providers, and industry will be better informed when academic investigators are able to facilitate the independent assessment and dissemination of data relevant to the benefits and harms of industry products, and that these assessments will allow physicians and patients to base their decisions on the most comprehensive and contemporary evidence available.
Requests for clinical trial data from any YODA Project partners may be directly submitted to the YODA Project through its website. The YODA Project advocates for the responsible sharing of clinical research data, 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.