With the ultimate goal of fostering transparency and improving the health of patients, the Yale University Open Data Access (YODA) Project has entered an agreement with SI-BONE, Inc. that will enable researchers across the world to gain access to the company’s key clinical studies of the iFuse Implant System®, a minimally invasive surgical device used to treat certain disorders of the sacroiliac joint.
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. This partnership establishes an independent process that promotes open science and has a goal of leveraging prior research investments to produce new knowledge.
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 Dr. Harlan Krumholz, 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 Dr. Joseph S. Ross, 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.”
Dr. Daniel Cher, 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.”
This partnership is part of the larger YODA Project mission to promote scientific inquiry and lower barriers to data access. Access to these data will allow validation of clinical results, exploration of new hypotheses, and will promote the highest standards for clinical trial transparency and open science for medical device research.