Johnson & Johnson subsidiary Janssen Research and Development has entered into a novel agreement with Yale School of Medicine's Open Data Access (YODA) Project to extend its commitment to sharing clinical trials data to enhance public health and advance science and medicine.
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 J&J, 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, M.D., chief medical officer for 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."
YODA will 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 will select and appoint an independent external panel of non-Janssen experts to help assess requests in some cases.
J&J also is committed to the sharing of data from clinical trials of the medical device and consumer products of the J&J 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, M.D., chief scientific officer, J&J & 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 also has launched a new web-based mechanism to assist researchers in requesting access to data from the company's clinical trials.
The J&J companies 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 trial data transparency. Additionally, J&J and Janssen support the overall PhRMA-EFPIA principles of greater clinical trial data transparency and sharing, including registration and disclosure of 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, M.D., Ph.D., global head, Janssen R&D.
"We are delighted that through agreement with YODA,” he said, “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."