Before new treatments can reach the clinic, they must be tested in clinical trials to see if they are safe and effective. Trials that do not enroll enough participants present barriers to advancing care to the clinic because they offer no scientific insight, waste money and time, and inflate the costs of new treatments.

Improving clinical trial efficiency – ensuring strong patient recruitment while minimizing cost and waste – is a top priority for the Clinical and Translational Science Awards (CTSA) Consortium, which serves as a laboratory for testing new ways to accelerating the translation of care into the clinic.

In a recent article in the Journal of Clinical and Translational Science (JCTS), a team from the Medical University of South Carolina (MUSC), academic home of the South Carolina Institute for Clinical and Translational Research (SCTR), describes an integrated tool that helps them track clinical trial enrollment and cost-effectiveness across the MUSC healthcare system. The tool integrates a commercial clinical trial management system (CTMS), with the Research Integrated Systems Network (RINS) created by MUSC, which tracks study-level data on otherwise siled systems. The integration allows study teams, administrators, and evaluators to ensure that trials are the best fit for the business and track their study progress.

“We needed a platform where we could track all of our studies that were recruiting patients, all of the patients that were enrolled in research, and whether they were also clinical patients at MUSC.” –Royce Sampson

Royce Samson

“We needed a platform where we could track all of our studies that were recruiting patients, all of the patients that were enrolled in research, and whether they were also clinical patients at MUSC. Also, introducing a clinical trial management system into RINS will allow us to really look at finances, especially for industry trials,” said Royce Samson, lead author of the JCTS article. Sampson is the director of Office of Clinical Research (OCR) and Director of Operations and Associate Director of SCTR.

RINS was created by SCTR and the Biomedical Informatics Center (BMIC) to capture protocol-level data across systems. None of the existing systems captured patient associations, so a CTMS was identified to fill this gap. The integration of a CTMS provided the missing piece of the puzzle, according to Jillian Harvey, Ph.D.., lead author of the JCTS article. Harvey is the director of assessment at the SCTR and an associate professor in the College of Health Professions.

“In the past, we’ve had difficulty accessing the data needed to track clinical trial metrics,” Harvey said. “CTMS/RINS allows us to get our hands on tracking and reporting our results and being effective with our data and evaluation.”

“In the past, we had difficulty accessing the data needed to track clinical trial metrics. CTMS/RINS allows us to get our hands on tracking and reporting our results and being effective with our data and evaluation. — Jillian Harvey, Ph.D.

Jillian Harvey, Ph.D., of the College of Health Professions and the Institute for Clinical and Translational Research of South Carolina
Jillian Harvey, Ph.D.

Previously, tracking clinical trial metrics too often meant manually extracting and calculating data. The teams transmitted all the data sets they had. Leila Forney, DNP, associate director at OCR, recalls the arduous work of gathering the data for a CTSA grant renewal, which took nine months. Now the process is much easier.

“Having an electronic platform for clinical trial data really helps you think about the metrics you’re seeing and figure out where you can make improvements,” Forney said. “It also helps us ensure that the data is accurate.”

The CTMS implementation was led by Steve Shapiro.

The newly integrated tool also helps MUSC researchers choose the right trials and size them right – setting a realistic enrollment goal – for the institution.

“CTMS/RINS helps us take an even more informed approach to the trials we select, where we place them, where the greatest needs are and where the gaps are,” said Signe Denmark, Associate Director of the ROC. “Overall, we’re getting better at knowing what our clinical trial portfolio looks like and how we’re managing it.

With the company’s recent expansion into other South Carolina counties as part of MUSC Health’s Regional Health Network (RHN), financial and patient accrual data available through CTMS/RINS can help clinical research managers to select not only the right trials, but also the right location for those trials.

“We are exploring how we can provide more research opportunities to these rural communities,” Sampson said. “Residents of Florence, Marion, Lancaster and Chester counties live hundreds of miles from the nearest academic medical center or cancer treatment center, where clinical trials are usually offered. The CTMS/RINS integration could help us select the appropriate assays to bring to them. It’s going to be innovation.

Sign Denmark from the Office of Clinical Research and Wenjun He from the Center for Biomedical Informatics reviewing clinical trial data on a computer
Signe Denmark and Wenjun He, Ph.D.

The integration also standardizes data collection across survey teams and incentivizes them to keep updating their data.

“With a system like a clinical trial management system, when study teams start using it as their primary source to track their study, they are responsible for updating their information. So it’s also more transparent,” said Wenjun He, Ph.D., assistant research professor at BMIC.

MUSC can report these performance measures to trial sponsors, giving the institution’s study teams a competitive edge.

“CTMS/RINS helps us take an even more informed approach to the trials we select, where we place them, where the needs are greatest and where the gaps are. — Sign Denmark

The first users of CTMS/RINS were OCR, which used it to initiate and track COVID-19 clinical trials, and the Office of Clinical Trials at Hollings Cancer Center (HCC).

“The Hollings Cancer Center began using the new Clinical Trials Management System in fall 2020 to store all study-level and patient-level data,” said Tricia Bentz, administrative director of the Office of Clinical Trials at HCC. . “The CTMS/RINS integration has improved the data quality of study details within institutional systems and has generated new efficiencies and work tools for management and staff. The integrated data structure is a promising basis for real-time reporting and support for data-driven strategic planning. »

Since March, all new study teams are required to register their studies in the new CTMS. This process will be ongoing and supported by OCR staff. Ongoing improvements will be made to MUSC’s CTMS/RINS integration. Plans are already underway to take it to the next level and create dashboards to provide transparent and easily accessible data to support study teams, Sampson explained.

The CTMS/RINS integration will not only benefit MUSC clinical trials, but could also provide a model for nationwide CTSAs, although it would need to be tailored to each institution’s particular data ecosystem.

“It’s core to our mission to make the process from discovery to people impact faster and more efficient, with better results,” said Harvey. “It just fits into the mission of CTSA as an area we need to look at.”

Reference

Sampson, R., Shapiro, S., He, W., Denmark, S., Kirchoff, K., Hutson, K., . . . Harvey, J. (2022). An integrated approach to improving clinical trial efficiency: linking a clinical trial management system to the integrated research systems network. Journal of Clinical and Translational Sciences,6(1), E63. do I:10.1017/cts.2022.382