Thanks to a $24.5 million grant from the National Institutes of Health National Center for Advancing Translational Sciences (NCATS), Johns Hopkins Medicine today announced plans to continue with a trial innovation center (TIC) that will promote improvements in the efficiency and quality of National Institutes of Health-funded clinical trials across multiple disease areas. The innovations developed by this program will help accomplish NCATS’ vision of a future with more treatments for all people more quickly in pursuit of efficient translation of science into patient care.
“We are excited to have NCATS support to continue our work to improve investigator-initiated clinical trials by providing new methods, designs and operational tools that make it easier to complete clinical trials,” says Daniel Hanley Jr., M.D., division director of the BIOS Clinical Trials Coordinating Center (BIOS CTCC), TIC leader and a professor of neurology, neurosurgery, nursing, and anesthesiology and critical care medicine.
Some researchers say there is an opportunity to shorten the timeline of some trials. To help achieve this, the TIC team will work to improve participant engagement, intervention adherence and measurement of trial endpoints. They will also measure benefits using explicit efficiency- and quality-focused metrics. Their efforts will demonstrate that better trial performance can include faster startup, quicker completion, greater protocol compliance and more precise endpoints.
The BIOS CTCC team of experienced trial scientists, project managers, statisticians and trial operations staff will continue their work with a TIC at Vanderbilt University, as well as the Recruitment Innovation Center at Vanderbilt. They will also work with external Clinical and Translational Science Award (CTSA) collaborators from five research-intensive universities (Northwestern, University of Chicago, University of Kentucky, West Virginia University and University of North Carolina Chapel Hill).
In its first seven years, the TIC team developed and demonstrated new methods for multicenter trials. These innovations include an accelerated startup program, gamification in clinical trial operations and AI-enhanced patient screening.
The accelerated trial startup program has increased research site productivity and reduced costs by streamlining the trial startup process from 365 days to 90 days or fewer. The program, which has been used in TIC-run trials, pairs sites with an experienced navigator, who helps guide each site through the extensive training, documentation and other preparations required for clinical trial excellence.
Additionally, gamifying clinical trial operations adds a new dimension to research studies. Sites participate in a game designed to enhance engagement and overcome communications pitfalls and burnout. Gaming aims to improve metrics like patient screens, enrollments and data entry while creating friendly competition to encourage optimal performance.
BIOS CTCC is also implementing cloud-based artificial intelligence resources to process medical scans of patients with brain bleeds in real time. This tool removes trial-related human file handling and enhances the precision and speed of patient screening to yield critical improvements for research into a condition where every minute counts.
Plans for the next TIC chapter include launching a trial operation training academy, enhancing and refining the implementation of TIC Data Coordinating Center and Clinical Coordinating Center operational processes to further improve the efficiency and quality of multisite randomized clinical trial planning and subsequent execution, and continuing as an innovation testing laboratory.
“We hope this award will help grow the number of trials that are performed nationally, and that the quality of those trials’ results will lead to nationwide dissemination of the trial planning and operational processes that we have developed and will continue to develop over the next five years,” says Hanley.
The TIC has benefited from close collaboration between BIOS CTCC and the Institute for Clinical and Translational Research. Hanley serves as a deputy director and leader for Johns Hopkins multisite clinical trials program.
“Clinical trials remain the gold standard for determining if a new drug or device leads to better outcomes,” says Daniel Ford, M.D., M.P.H., senior associate dean and director of the Institute for Clinical and Translational Research. “With this award, Johns Hopkins can continue to lead in helping research teams accomplish clinical trials with faster speed, efficient use of funding and more authentic patient engagement. In addition, we will train a cohort of young investigators to give them the skills needed to take on the challenge of large clinical trials.”
Hanley will continue to work with Karen Lane, operational deputy director and TIC faculty research lead. Lane’s academic focus is the art and business of clinical trial science.
“Clinical trial science spans a broad range of multicenter trial activities, including design, implementation and dissemination,” says Lane. “It also includes innovation — tools and ideas that engage research teams and enhance the informativeness and quality of clinical trials. We look forward to this next phase and sharing these tools and ideas across our network of innovation centers and CTSAs around the country.”