Pragmatic Clinical Trials
With their low costs and increased efficiency, pragmatic clinical trials have the potential to completely shift the clinical research paradigm.
Medical care should be guided by strong evidence. A high-quality randomized controlled trial is one of the best possible sources for such evidence, but these trials are often expensive, inefficient, and slow to provide results. And without good ways to efficiently analyze and communicate this evidence and identify best practices, the result is often widespread variation in medical practice—and ultimately, in the quality of care that patients receive.
We need bigger, better, and more efficient trials. A type of study design known as a pragmatic clinical trial leverages new technologies and methods to gather needed evidence from larger, more representative groups of patients, and at a small fraction of the cost of ordinary clinical trials. By developing and applying pragmatic methodologies, we can be catalysts for change in a clinical research system in need of transformation.
Adrian Hernandez, MD, MHSDirector, Health Services Research Group
"What if instead of spending $30 million to answer a single question, we could spend $3 million and answer 10?"
The ADAPTABLE study is leading the way in demonstrating how clinical trials can use electronic health records to efficiently collect patient data for research. It’s one way the DCRI is changing the standards for clinical trial design.
Electronic health records can be leveraged for every stage of a pragmatic clinical trial.
A Pragmatic Approach
Matthew Roe, MD, MHS discusses the unique and innovative elements of the ADAPTABLE study.
Supported by the Common Fund at the National Institutes of Health (NIH), the NIH Health Care Systems Research Collaboratory aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.
The Collaboratory also supports the design and rapid execution of pragmatic clinical trial demonstration projects that address questions of major public-health importance and engage healthcare-delivery systems in research partnerships. These projects help to establish best practices and provide proof of concept for innovative designs in pragmatic clinical research.
Data, tools, and resources produced by the Collaboratory are made available to the greater research community to promote partnerships with healthcare systems and propel a transformation in how clinical research is conducted. Dissemination efforts include the Collaboratory’s Knowledge Repository, Living Textbook, and weekly Grand Rounds webinar series.
Director, Global Outcomes Commercial Megatrials
Lisa Berdan has been involved in cardiovascular (CV) megatrials for over 20 years and has successfully developed an industry-recognized operational business unit including over 70 clinical operations professionals who are dedicated to these large international programs in acute coronary syndromes, atrial fibrillation, chronic coronary artery disease, diabetes, and peripheral arterial disease. These trials typically have at least 5,000 patients enrolled in multiple countries and include ASCEND HF, EXSCEL, IMPROVE IT, ROCKET AF, TECOS, TRACER, TRILOGY, Roche dal-O2 and AZ-PAD.
Berdan is responsible for leading the strategy, growth, and expansion of this significant area of business as well as overseeing the operational implementation of all commercial (industry-funded) CV megatrials. She represents the DCRI and participates in organization-wide initiatives including 1) expanding collaboration with our global ARO partners, 2) collaborating with leadership to develop site-focused clinical research training programs and expanding global site relationships and networks, and 3) advising and collaborating with Brazilian Clinical Research Institute. She also provides senior mentoring, advice, and support to the DCRI Business Development and Clinical Operations groups.