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Courtesy of SI-BONE, Inc., Yale University and Yale University Open Data Access (YODA)

Yale, SI-BONE Commence Data Transparency Project

Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, May 19th, 2016

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Open sesame! It may seem like magic, but it’s a reality now. The Yale University Open Data Access (YODA) Project has entered an agreement with SI-BONE, Inc. that will enable researchers worldwide to gain access to the company’s key clinical studies of the iFuse Implant System.

As indicated in the May 12, 2016 news release, “SI-BONE will share data from their SIFI (Sacroiliac Joint Fusion With iFuse Implant System) study, and plans to share data from two additional trials within the next six months.”

“The YODA Project, which is part of the Yale-New Haven Hospital Center for Outcomes Research and Evaluation (CORE), will continue in its established role as a trusted intermediary and will perform an independent scientific review of requests for data access by non-study investigators. The YODA Project will have complete decision-making authority over the release of the data, which allows all requests for clinical data to be fairly judged and decided upon by an independent academic partner.”

“This is a remarkable action by SI-BONE that should accelerate the movement of the clinical research enterprise toward more cooperative learning and sharing, ” said Harlan Krumholz, M.D., S.M., professor of medicine and leader of the YODA Project. “By establishing this fair and independent process to release data, SI-BONE has embraced a position of leadership in this emerging era of open science.”

“Our mission at the YODA Project is to advocate for the responsible sharing of clinical research data in an effort to foster transparency and improve the health of patients, ” said Joseph S. Ross, M.D., M.H.S., co-director of the YODA Project and associate professor of medicine and public health at Yale University. “The YODA Project applauds SI-BONE’s forward thinking and commitment to open science. This partnership reflects the best practices recently recommended by the National Academy of Medicine for the responsible sharing of clinical trial data. We hope SI-BONE’s action will encourage other entities engaged in clinical research, including industry and academia, to share clinical research data in an effort to inform the public and ultimately raise the quality of evidence used to make decisions for health and healthcare.”

Daniel Cher, M.D., vice president of clinical affairs at SI-BONE, said, “We believe that the individual outcomes data underlying clinical research studies in both the commercial and academic worlds should be available for secondary analysis and confirmation. Data-sharing ensures transparency and allows more detailed analysis of relevant clinical outcomes.”

Dr. Ross told OTW, “We are very excited about this initiative with SI-Bone. They reached out to us with an interest in making their clinical trial data available to external investigators and we are pleased to serve as an intermediary between the company and data requestors. We believe this effort is in the best interests of science and will lead to a better, more in-depth understanding of the iFuse product, which will in turn improve outcomes for patients.”

“In a year, we will know if we’ve been successful if the data have been used, not simply shared. Sharing is the first step. But to advance our understanding and generate new knowledge, external investigators will need to make use of the data to pursue secondary research questions and test new hypotheses.”

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