By Jijo James, M.D., M.P.H., Chief Medical Officer, Johnson & Johnson, Consumer
Jijo James, M.D., M.P.H., Chief Medical Officer, Johnson & Johnson, Consumer
Data are powerful when leveraged effectively. This is especially true of the healthcare industry where data can be used to help people live longer, happier and healthier lives. Like most industries embracing advances in technologies and becoming ever more interconnected, generating vast amounts of data has become a byproduct of what we do. Across the healthcare industry we are witnessing a rise in data volume due to increasing adoption of electronic health records as the common method of practice. Patients’ information needs to be continuously updated, tracked, shared and queried to ensure proper care is administered. This also holds true for clinical data collected during research & development. It’s almost too much to fathom. However, these data shouldn’t just be locked away for only a few to review, analyze and use.
Support for data transparency must continue to grow in the healthcare industry. By sharing data, we can ensure that researchers around the globe have more information about the safety and effectiveness of products–from pharmaceutical medicines, to consumer products, to medical devices. For those of us who live and breathe data every day as part of our work, it is no mystery that having access to more information makes us more effective and can advance science.
I’m fortunate to work with a talented team of colleagues who understand that sharing clinical trial data ensures that we keep patients and consumers at the heart of all we do. Clinical trial participants, sometimes ill and looking for help, have given their time–and their bodies–to advance medical research and to help others. By unlocking the power of data generated by clinical trials and sharing it, anonymized, and responsibly with researchers around the world, we can advance the state of healthcare. That’s powerful!
Over the last several years, the pharmaceutical business of Johnson & Johnson and other prominent pharmaceutical companies have made public commitments around sharing clinical trial data. Through a partnership with the Yale University Open Data Access (YODA) Project, one of several pioneering data-sharing models already in use throughout the industry, clinical trial results of Johnson & Johnson companies are shared with those interested in conducting additional research using data from clinical trials of approved products.
"Regulators, academic researchers, patients and consumers–all critical participants in the healthcare ecosystem–are looking to leverage data to glean insights and advance public health"
At the heart of the YODA Project is the view that patients, providers, and the industry will be better served if evaluation of the research requests was conducted through an independent body. A process was created as part of the agreement in which requests from external researchers for clinical trial data would be managed through the YODA Project team. They are responsible for determining if a request meets the appropriate scientific standards. Data are shared through a secure platform and once a request is approved, a data use agreement is signed and access is granted.
I’m particularly proud that earlier this year the Johnson & Johnson Consumer companies followed our Pharmaceutical and Medical Device companies to become the first consumer company to make clinical trial data available to researchers through the YODA Project. We felt it was important for the millions of consumers who use our products every day to know we are committed to rigorous scientific assessments to support the safety and efficacy of our products from across all segments of our business–pharmaceutical, medical device and consumer. The philosophy behind making these data available is equity in science. Consumer healthcare products should receive the benefit of the same rigor and assessment as more complex pharmaceuticals and medical devices.
A Call for Stronger Commitments
While the pharmaceutical industry has made great strides in advancing science and promoting evidence-based practices, the future of broader healthcare data sharing remains uncertain. Regulators, academic researchers, patients and consumers–all critical participants in the healthcare ecosystem–are looking to leverage data to glean insights and advance public health. The ecosystem would benefit from greater harmonization in how these data are being made available, and to what extent.
However, the real power in data sharing will be achieved when all stakeholders openly participate. My hope is that like some of the bigger pharmaceutical companies, other large medical device and consumer companies can be “big for good” by using their resources to advance science. By participating in transparent data sharing and creating a thoughtful evidence- and science-based approach, we will be aiding the entire ecosystem.
I strongly encourage those in the life sciences industry, pharmaceutical, medical device and consumer alike, to make a commitment to be transparent with their clinical trial data for the good of society. When this is accomplished patients and consumers will benefit. Together, we can unlock the power of data. This is not easy, but when has that ever stopped us?