Sharing data from clinical trials with other researchers can lead to greater insights in science and medicine and advance medical care. Consequently, Johnson & Johnson expanded a collaboration with the Yale University School of Medicine’s Open Data Access (YODA) Project in January 2015 to make available clinical trials on its new medical devices. Last year, Johnson & Johnson set new industry standard by being the first company to share clinical trial data for pharmaceutical products through an independent third-party, giving the YODA Project independent authority to decide what clinical trials data from its pharmaceutical companies would be shared with which researchers.
“Our agreements with the YODA Project underscore our commitment to responsibly share clinical trial data with researchers in a way that we believe advances medical science and public health,” said Joanne Waldstreicher, M.D., Chief Medical Officer, Johnson & Johnson.
For example, through the YODA Project, Guru Sonpavde, M.D., University of Alabama, Birmingham School of Medicine, requested clinical trial data for ZYTIGA® (abiraterone acetate) to help him develop a new way to assess treatment success in metastatic castration-resistant prostate cancer (MCR-PC).
Dr. Sonpavde explains: Changes in PSA (prostate-specific antigen, a biological indicator of prostate growth, sometimes due to cancer) and bone scan findings are currently used as intermediate endpoints to evaluate new treatments for this form of prostate cancer in phase II trials. The result of that analysis often determines launching phase III trials. But PSA and bone scans may not always be sufficient for determining the value of a new treatment, so progress toward new treatments may slow.
“Better imaging technology is allowing the frequent detection of objectively measurable tumors using response evaluation criteria in solid tumors (RECIST),” he says. “If response by RECIST can be demonstrated to be strongly associated with and used as a surrogate for overall survival improvement, new agents can be evaluated using this objective endpoint.” Using these new endpoints, treatments for prostate cancer could possibly be developed more quickly and brought to patients even faster.
Dr. Sonpavde sought data from ZYTIGA® clinical trials to help him test this strategy using robust data sets.
Building upon the first agreement announced in January 2014, the YODA Project serves as a fully independent academic group at Yale University School of Medicine that manages requests from medical researchers for access to clinical trial data from the Johnson & Johnson pharmaceuticals and medical devices businesses. Under the agreement, the YODA Project makes final decisions about what data will be provided to the requesting scientist.
In October 2014, the YODA Project launched a new online website to assist researchers requesting access to clinical trial data from Johnson & Johnson companies. As of February 2015, the first eight requests for pharmaceutical clinical trial data from the Janssen Pharmaceutical Companies of Johnson & Johnson, had been approved through the YODA Project and provided to the investigators. Details about the research requests, including the specific research questions, can be found online.
“The YODA Project process was convenient and greatly facilitated access to the phase III trial dataset requested,” says Dr. Sonpavde. “We hope the YODA Project can continue its efforts in this direction by expanding the list of available trials.”
“I am gratified that the YODA Project is achieving the goal we have worked toward – getting clinical trials data into the hands of independent scientists to conduct additional analyses,” Dr. Waldstreicher said. “By responsibly sharing clinical data, Johnson & Johnson expects to speed the scientific discoveries that can advance medical care and improve public health.”