Johnson & Johnson To Share Clinical Trial Data With Yale School Of Medicine
By Ed Miseta, Chief Editor, Clinical Leader
In a move that is sure to be seen as a major win for advancing science and medicine, Johnson & Johnson has announced that Janssen Research and Development, LLC, has reached an agreement with the Yale School of Medicine’s Open Data Access (YODA) Project to share data from its clinical trials. According to the terms of the agreement, YODA, as an independent body, will review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, a subsidiary of J&J. In its role, YODA will also make final decisions on data sharing. According to the company’s press release, this will mark the first time any company has collaborated in this manner with an independent third party regarding requests for clinical data.
The release quotes Joanne Waldstreicher, MD, Chief Medical Officer of Johnson & Johnson as saying: “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. 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.”
Although YODA members may reach out to researchers at Janssen with questions, the agreement makes clear that the final decision on data sharing will be made by YODA. To assist in making these decisions, the YODA team will appoint an external panel of independent (non-Janssen) experts to assist in the decision-making process.
Paul Stoffels, MD, Chief Scientific Officer of Johnson & Johnson & Worldwide Chairman, Pharmaceuticals adds: “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. 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.”
In addition to the agreement with YODA, J&J is also attempting to assist researchers hoping to gain access to Janssen’s clinical trial data. The company has launched a web-based effort to facilitate that transfer. By going to www.clinicaltrialstudytransparency.com, researchers can make a request for clinical trial data from Janssen.
“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.”