A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face.
The 14 articles bring together leaders, researchers, biostatisticians, and bioethicists—including members of the NIH Pragmatic Trials Collaboratory — who are rethinking key aspects of the development, conduct, and oversight of clinical trials.
The articles include recommendations and real-world experience on how clinical trials can be done better while maintaining high-quality results using digital technology, direct-to-participant methods, and electronic health records.
The special issue is co-edited by Adrian F. Hernandez, MD, MHS, a co-principal investigator for the NIH Pragmatic Trials Collaboratory and vice dean and executive director of the Duke Clinical Research Institute, and Tammy Reece, MS, PMP, CCRA, the program’s project director and a senior project leader in DCRI’s Government Trials and Networks group.
Following an introduction written by Hernandez, the remaining 13 articles focus on topics including simplification by design, digital technologies and clinical trials, iterative approaches to the use of electronic health records data for large pragmatic studies, ethics and regulatory considerations, and lifestyle and behavioral modification trials.
This body of work offers pragmatic approaches to overcoming the many reasons clinical trials are underperforming, such as high financial costs, long duration, administrative complexity, low recruitment and retention of participants, and difficulty translating knowledge to actual medical care.
“The articles in this issue recognize advances in evidence generation while sharing the challenges and gaps that still need to be addressed,” Hernandez said. “Ultimately, the clinical research ecosystem must improve, not only to keep pace with the advances in science, but to improve public health in meaningful ways.”
“The NIH Pragmatic Trials Collaboratory has been working to re-engineer clinical trials for a decade, yet there is still progress to be made,” Reece said. “Sharing knowledge and innovations across disciplines is critical to continue the momentum of transformation toward a learning health system.”