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Janssen, the pharmaceutical companies of J&J, has enlisted Yale University through the Yale University Open Data Access (YODA) Project to extend its commitment to sharing clinical trials data to enhance public health and advance science and medicine.
Under the agreement, YODA will act as an independent body to review and make final decisions regarding all investigator requests for clinical trial data for its treatments, including clinical study reports (CSRs) and de-identified patient-level data.
J&J also announced a new website at www.clinicaltrialstudytransparency.com to assist researchers in request for data.
Other pharmaceutical companies, including GlaxoSmithKline (GSK), Pfizer, Roche and Sanofi have recently granted access to their clinical trial data, but the J&J initiative is the first industry-academic model of its kind.
In a statement, Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson, said:
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.
Researchers will be able to submit proposals to use data from studies of J&J products. The data will be free of charge and will not have information that can identify individuals. Submitted proposals will be posted publicly and registered at clinicaltrials.gov. The investigators will be responsible for reporting their results.