September 19, 2017 – The NIH Collaboratory is celebrating five successful years of innovation in pragmatic clinical trials.
The Common Fund at the National Institutes of Health (NIH), which supports innovative endeavors with the potential for extraordinary impact, instituted the NIH Health Care Systems Research Collaboratory five years ago in 2012, with its coordinating center based at the DCRI. The goal of the program is to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. At a time when reducing the cost of clinical trials and generating real-word knowledge is becoming progressively crucial, the NIH Collaboratory is leading the way in expanding the national capacity for pragmatic clinical research.
“The NIH Collaboratory embodies what makes clinical research exciting and simply fun,” said Adrian Hernandez, MD, one of three principal investigators of the NIH Collaboratory coordinating center at the DCRI. “We’ve learned together how to address challenges and then seeing how those solutions go forward to change how clinical trials should be done as opposed to how they are currently done.”
Providing national leadership and technical expertise in all aspects of research with healthcare systems, the DCRI has worked with the NIH and other coordinating centers at the Center for Medical Technology Policy, Harvard Pilgrim Health Care Institute, Group Health Research Institute, and Johns Hopkins Berman Institute of Bioethics over the last five years to produce, document, and disseminate standards for healthcare systems research. Together they have created an infrastructure to facilitate multi-center studies and the responsible use of electronic health data. They have also been able to establish a structure supporting research with healthcare systems as partners.
“The hallmark of the NIH Collaboratory over the last five years has been the spirit of collaboration and curiosity from all the investigators,” said DCRI’s Kevin Weinfurt, PhD, co-principal investigator (pictured left). “One of the most prominent accomplishments of the Collaboratory during this time is successfully planning 10 very complex pragmatic clinical trial Demonstration Projects spanning 12 NIH institutes and centers, 9 of which proceeded to full implementation.”
The NIH Collaboratory’s pragmatic clinical trial Demonstration Projects gather real-world evidence to answer clinical questions of major public health importance and engage healthcare delivery systems in research partnerships. Seven Core Working Groups of experts, each focused on a specific topic, support all of the Demonstration Projects and initiatives across the program, helping the research teams navigate issues of research embedded in clinical care, as well as collect knowledge gained throughout the process.
“All of us in the NIH Collaboratory have learned a tremendous amount about how to successfully embed pragmatic clinical trials in health care delivery systems,” said DCRI’s Lesley Curtis, PhD, co-principal investigator (pictured right). “What’s most exciting is the universal commitment to sharing successes, surprises, and missteps so that we build the evidence base about embedded research while the trials answer important questions.”
Knowledge sharing has been a key component of the NIH Collaboratory over the past half a decade. Weekly Grand Rounds, delivered in the form of webinars, have been highly successful and provide a forum for sharing the latest advances in pragmatic research. Attended by a large audience of researchers and others in the clinical research community, including representatives from NIH and the U.S. Food and Drug Administration, the Grand Rounds also serve as a platform to discuss how to successfully conduct pragmatic clinical trials within the current ethical and regulatory framework for research.
“Another noteworthy accomplishment of the Collaboratory in the last five years is the creation of the continuously evolving Living Textbook, which is an easily available online repository of the
lessons learned from the Collaboratory,” said Weinfurt. “To support the wider conduct of pragmatic trials, the investigators put in a lot of effort to update the Living Textbook as experiences were accumulated.”
Together with the DCRI, the program built a Knowledge Repository, a publicly available archive of resources related to the conduct of pragmatic trials. In the same spirit, it also created the NIH Collaboratory Distributed Research Network, which facilitates multi-site research collaborations to allow researchers to query electronic health records of over 90 million individuals in a way that protects participant privacy. According to the investigators, this paves the way for standards in data sharing, data quality, and reuse of electronic health record data.
“It takes a village,” said Tammy Reece, Project Leader of the NIH Collaboratory at the DCRI. According to Reece, the success is in the numbers: with more than 500 resources achieved in the Knowledge Repository, more than 200 Grand Rounds held since inception along with over 70 conference presentations or symposia, more than 60 total publications, and more than 320 citations in peer-reviewed journals, and these numbers are still growing.
According to the investigators, the numbers from the last five years add up to success but there is still much to achieve for both the DCRI and the NIH Collaboratory.
“In the future, we would like to see the Collaboratory learn a bit more about how to implement pragmatic trials in less than optimal settings with a goal to empower all health systems to be able to conduct trials on a variety of different platforms,” said Weinfurt. “Empowering health systems is an important and unique feature of the Collaboratory as a network.”