Innovation in the interest of public health happens faster when researchers in both the public and private sectors share information and work together. We’ve seen this happening to the greatest extent during the current Ebola epidemic. Imagine if this were the new culture and the new standard in science. If done responsibly so that we could also maintain a healthy R&D ecosystem, sharing data from clinical studies can help advance the science that is the foundation of all medical care.
Our primary responsibility, as one of the most broadly based healthcare companies in the world, is to the doctors and nurses, patients and consumers, mothers, fathers and children who use our products. That means taking a patient and consumer-centered approach to advancing medical science through all of our products that touch people in different ways. It also means we have the opportunity to set the standard and be leaders and role models in advancing best practices that will ultimately advance science and medicine.
When we announced early last year that we would partner with the Yale School of Medicine Open Data Access Project (YODA) to serve as an independent reviewer for every request for clinical data from our pharmaceutical studies, we broke new ground in data transparency. While other companies selected external experts for their own external review panel, we were the first to work with a completely independent academic group which took full responsibility to review data requests and made the final decision on access to our data. At the time, we announced our intent to work initially with pharmaceutical clinical studies, and then extend the collaboration even further in the future to include requests for data from our clinical studies of medical devices.
Today, we made good on that promise and continued to set the bar for clinical data transparency even higher. To date, no other device company has agreed to move forward with sharing all of its future clinical trial data. We hope that our approach will serve as a role model that ushers in a new era for responsible data sharing across the device industry as well as academia.
Our news comes in conjunction with an Institute of Medicine (IOM) report on clinical data sharing that was issued today. The report makes important and bold recommendations for how the broad healthcare R&D ecosystem – industry, academia, foundations and others who fund and conduct clinical trials – should approach data sharing. Notably, one of the key recommendations is that after publication of the results of a clinical trial, journals should require that the authors commit to sharing the analytic data set supporting the results, tables and figures no later than six months after publication. This would represent an important step change in the culture of science to one that is more open and transparent, stimulating new hypotheses, getting the most out of studies already conducted and raising the bar on the overall scientific quality of trials. We recognize that there will be challenges along the way but believe that this new culture will ultimately enhance the R&D ecosystem and benefit overall public health.
I am pleased to have served on the IOM committee that developed the recommendations in the report, and participated in the committee’s NIH, FDA, industry, foundations and public briefings over the past few days.
By setting and implementing new responsible data sharing standards and commitments and working together across public and private stakeholders, we are taking a leadership role in advancing science and medicine and making a difference for consumers and patients, one person at a time.