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In addition to Janssen's sharing of data from pharmaceutical product clinical trials through the agreement with YODA, Johnson & Johnson is also committed to the sharing of data from clinical trials of the medical device and consumer products of the Johnson & Johnson family of companies.
"Responsible sharing of clinical trial data advances science and medicine and is part of Johnson & Johnson's commitment to the doctors, nurses, patients, mothers, and fathers and all others who use our products," said Paul Stoffels , MD, Chief Scientific Officer, Johnson & Johnson & Worldwide Chairman, Pharmaceuticals. "Our agreement with YODA exemplifies the Johnson & Johnson family of companies' commitment to science, medicine and public health by creating a standardized independent, transparent and reproducible process for sharing our clinical trial data."
Janssen has also launched a new web-based mechanism to assist researchers in requesting access to data from the company's clinical trials. External researchers can make a request for clinical trial data on products from Janssen, the pharmaceutical companies of Johnson & Johnson, using the following link: www.clinicaltrialstudytransparency.com .
The companies of Johnson & Johnson continue to maintain their longstanding policies for registration and publication of clinical trial data, irrespective of the outcome of the studies, and to support the overall principles of greater clinical trial data transparency. Additionally, Johnson & Johnson and Janssen support the overall PhRMA-EFPIA principles of greater clinical trial data transparency and sharing, including registration and disclosure of clinical trial results in external registries, publication of results in peer reviewed journals, and sharing of Clinical Study Reports.
"We already have well established policies for registration and disclosure of clinical trial results in external registries as well as publication of results in peer reviewed journals, and we have historically worked with external researchers to address other types of data requests," said Bill Hait , MD, PhD, Global Head, Janssen R&D.
"We are delighted that through agreement with YODA, we will now be able to share data from our clinical trials in the form of Clinical Study Reports (CSRs) and participant level data in a systematic and objective way that advances medicine and scientific knowledge while protecting patient privacy and confidentiality," Dr. Hait added.
More information about the YODA Project can be found at http://medicine.yale.edu/core/projects/yodap/index.aspx .
About Janssen Research & Development, LLC At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development is part of the Janssen Pharmaceutical Companies. Please visit www.janssenrnd.com for more information.
About Johnson & Johnson Caring for the world, one person at a time…inspires and unites the people of Johnson & Johnson. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 128,000 employees at more than 275 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Contact: Seema Kumar Johnson & Johnson Office: 908-218-6460 Office: 732-524-2646 Mobile: 908-405-1144 [email protected]
SOURCE Johnson & Johnson