Welcome!

News Feed Item

Johnson & Johnson Announces Clinical Trial Data Sharing Agreement With Yale School of Medicine

NEW BRUNSWICK, N.J., Jan. 30, 2014 /PRNewswire/ -- Johnson & Johnson today announced that its subsidiary, Janssen Research and Development, LLC, has entered into a novel agreement with Yale School of Medicine's Open Data Access (YODA) Project that will extend its commitment to sharing clinical trials data to enhance public health and advance science and medicine.  Under the agreement, YODA will serve as an independent body to review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, the pharmaceutical companies of Johnson & Johnson, and make final decisions on data sharing. This is the first time any company has collaborated with a completely independent third party to review and make decisions regarding every request for clinical data.

"Sharing anonymized data from clinical trials is critical to advance public health because it furthers our understanding of diseases, expands the base of knowledge needed to develop new treatments, and generates new insights and more complete evidence to enable better healthcare decisions for patients - all while protecting patient privacy and confidentiality," said Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson. "We are pleased to collaborate with YODA to ensure that each and every request for access to our pharmaceutical clinical data is reviewed objectively and independently.  This represents a new standard for responsible, independent clinical data sharing."

Under the agreement, YODA will independently review and make final decisions regarding all requests for the company's clinical trial data including clinical study reports (CSRs) and de-identified patient-level data.  While YODA members may reach out to Janssen researchers with questions, the final decision on data sharing will be made by YODA. Members of the YODA team at Yale School of Medicine will select and appoint an independent external panel of non-Janssen experts to help in some cases to assess requests.

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Predictive analytics tools monitor, report, and troubleshoot in order to make proactive decisions about the health, performance, and utilization of storage. Most enterprises combine cloud and on-premise storage, resulting in blended environments of physical, virtual, cloud, and other platforms, which justifies more sophisticated storage analytics. In his session at 18th Cloud Expo, Peter McCallum, Vice President of Datacenter Solutions at FalconStor, discussed using predictive analytics to mon...
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Join Impiger for their featured webinar: ‘Cloud Computing: A Roadmap to Modern Software Delivery’ on November 10, 2016, at 12:00 pm CST. Very few companies have not experienced some impact to their IT delivery due to the evolution of cloud computing. This webinar is not about deciding whether you should entertain moving some or all of your IT to the cloud, but rather, a detailed look under the hood to help IT professionals understand how cloud adoption has evolved and what trends will impact th...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
We are always online. We access our data, our finances, work, and various services on the Internet. But we live in a congested world of information in which the roads were built two decades ago. The quest for better, faster Internet routing has been around for a decade, but nobody solved this problem. We’ve seen band-aid approaches like CDNs that attack a niche's slice of static content part of the Internet, but that’s it. It does not address the dynamic services-based Internet of today. It does...
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.