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, MHSVice Dean for Clinical Research,
Duke University School of Medicine
DCRI Faculty Associate Director
Professor of Medicine, Cardiology
"What if instead of spending $30 million to answer a single question, we could spend $3 million and answer 10?"
ADAPTABLE and the Future of Clinical Research
Former FDA Commissioner and DCRI founder Robert Califf, MD, describes how ADAPTABLE serves as a model of evidence generation to answer critical, pragmatic questions quickly.
Good Clinical Practice Guidance and Pragmatic Clinical Trials
DCRI authors weigh in on how to resolve the tension inherent in the central tenets of Good Clinical Practice guidelines and pragmatic clinical trials.
The Future of the NIH Collaboratory
Kevin Weinfurt, PhD, Lesley Curtis, PhD, and Adrian Hernandez, MD, MHS, discuss the next phase of the NIH Collaboratory program, including what they are most excited about.
Collaboration: The NIH Collaboratory
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. 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.
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.
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 also provides senior mentoring, advice, and support to the DCRI Business Development and Clinical Operations groups.