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 Enrolls 15K Patients Using Electronic Health Records
ADAPTABLE, a trial designed to use pragmatic approaches to answer critical questions, reached its enrollment goal of 15,000 patients. This enrollment was completed partially through identifying patients via their electronic health records.
The Future of Pragmatic Clinical Trials
Robert Mentz, MD, discusses features of pragmatic heart failure trial TRANSFORM-HF with a representative from the trial's sponsor, as well as considerations for how pragmatic clinical trials will be conducted as they continue to gain importance.
Pragmatic Approaches to Address Current Public Health Crises
The DCRI received more than $19 million in funding from the NIH for research projects related to preventing or treating opioid addiction. One of the projects is a coordinating center to support pragmatic studies working on this challenge.
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.