By Deborah Borfitz 

July 14, 2022 | Until recently, clinical study teams at the Medical University of South Carolina (MUSC) had no single system for registering participants in their trials and keeping track of upcoming study visits, critical time windows around the collection of samples and administration of investigational products, and what to invoice when on industry-sponsored projects—or even which balls were in their court to keep the research process moving forward. Without an enterprise-wide platform, its Office of Clinical Research (OCR) also had no practical way to know how many patients coming to MUSC for specialized clinical care were participating in research, let alone if those studies were meeting their target enrollment, according to OCR Director Royce Sampson, noting that many other institutions face similar challenges. 

All that is changing at MUSC with implementation of a clinical trials management system (CTMS), fully integrated with the university’s Research Integrated Network of Systems (RINS), in mandatory use since March 2022 for all new trials undertaken across campus. It is but the latest accomplishment in MUSC’s extended journey toward integrating the two dozen systems currently supporting the research enterprise for the state’s premier biomedical research institution, says Sampson, who is also chief operations officer and associate director of the South Carolina Clinical & Translational Research (SCTR) Institute, a Clinical and Translational Science Award (CTSA) program hub at MUSC funded by the National Institutes of Health. 

MUSC has been working on optimizing RINS since its creation in 2016 as a virtual data warehouse linking study-level data across disparate systems relevant to clinical research. It has been such a mammoth undertaking that only now is a project underway to create a functional and useful study activation dashboard for study teams, Sampson says. 

An article that recently published in the Journal of Clinical and Translational Science (DOI: 10.1017/cts.2022.382) describes the CTMS/RINS integration and its potential to improve clinical trial efficiency, compliance, and cost-effectiveness. Low-accruing clinical trials have been particularly problematic in that they are both unlikely to reach the statistical power to be clinically relevant and end up costing their host institutions money, she notes. 

Prior to CTMS integration, RINS was uniting systems designed for operational purposes by specific offices, continues Sampson. Among these are research services transaction management (SPARCRequest), electronic health record (Epic), electronic institutional review board (eIRB), financials (SmartStream and ClinCard), sponsored awards, and faculty management. 

But RINS was of no help in tracking participant enrollment for all trials at MUSC and did not provide a comprehensive picture of the financial impact of industry-sponsored research without an integrated CTMS. “If we don’t have the metrics, we can’t identify where the pain points are and where we need to focus our resources and efforts,” she says.  

The Backstory 

The CTMS/RINS integration will be vital to the management of industry-sponsored trials where information on regulatory and recruitment milestones is in high demand, Sampson says. The long, hard road to this point began with receipt of a CTSA grant back in 2009 when SCTR joined peer institutions around the country seeking ways to collaboratively remove the challenges and barriers to clinical and translational research. 

Through the years, SCTR has developed systems to improve its tracking capabilities and, in some cases (e.g., SPARCRequest) those systems have been adopted by other CTSA hubs, she says. But the major enabler came from MUSC’s investment in RINS to un-silo data, under the leadership of Leslie Lenert, M.D., director of the Biomedical Informatics Center and assistant provost for data science and informatics.  

At the starting line, even the data field for something as basic as “date of contract” wasn’t matching up system to system, Sampson recalls. It took a team representing the various stakeholders to come up with a data dictionary for what information belongs where as well as how to pull and clean data from the different systems and agree on the source of truth—for instance, the eIRB for the identity of a study’s principal investigator (PI). 

“The [latest] CTMS piece was critical because we did not have a location for study teams to track their patients, patient visits, and work that they’ve done on studies in a way where the data was retrievable,” says Sampson. To get a read on recruitment trends required a database where all studies were tracked and interfaced with multiple other inhouse systems. 

OnCore (Advarra), a CTMS system widely used by cancer centers, was chosen for adoption, she reports. Outside of MUSC’s large, NCI-Designated Cancer Center (Hollings Cancer Center, HCC), only a couple of other groups were using any sort of CTMS. 

Phased Rollout 

The CTMS/RINS integration went live September 2020, right in the middle of the pandemic, and the HCC was the first to be onboarded. “It has a really strong clinical trials office and had a previous CTMS [Velos] that hadn’t really been upgraded in many years,” says Sampson.  

HCC conducts many clinical trials and, in addition to all new studies, all active ones and some archived ones were uploaded to OnCore, she says. Center staff have been “very satisfied” with the system’s reporting capabilities and “continue to mature their use over time.” 

Even before the CTMS became mandatory in March, some study teams outside HCC were opting to voluntarily enroll for training, she says. Once folks familiarized themselves with OnCore for their new studies, they wanted to also add in their active trials. 

The focus has been on supporting recruitment goals as well as tracking and invoicing for industry-sponsored trials, says Sampson. “Doing full recovery on the money earned is invaluable because research needs to be sustainable.” 

The OCR has assembled the infrastructure so protocol-level information in SPARCRequest gets pushed into OnCore and the study calendars can be shared between the two systems, she explains. Those calendars also get pushed from SPARCRequest to Epic to further lighten the administrative burdens on study coordinators and research administration staff. Without these integrations, study calendars would have to be built separately in each system, which could take up to three weeks per study to build.  

The OCR’s budgeting and invoicing team works “hand in glove” with study teams to ensure tracking is set up to match payment triggers as stipulated in industry contracts, says Sampson. This fall, a new integration with MUSC’s financial system will allow reconciliation of work performed and invoiced in the CTMS with payments received from sponsors, providing additional transparency and efficiency in research financial management.    

For the OCR, one long-term advantage of an integrated CTMS/RINS is that no data will be lost if it ever changes platforms, she says. The culture change has largely already occurred, with study teams training on the new CTMS. The ultimate goal is to find ways to reduce the administrative burden on study coordinators whose workloads have been growing exponentially over the past few decades. 

The intent here is to interface as many of the 24 internal systems as possible so data can be pulled between them and to leverage RINS to reduce the need for study teams to repeatedly enter the same information in multiple systems, says Sampson. The OCR sets up each study in the CTMS and trains study teams to register their patients and track their visits and invoiceable items to lessen the workload and training required of study coordinators.   

Maximizing Resources 

Within the first year of the OnCore implementation, 324 protocols were funneled through the integrated CTMS/RINS platform, and more than 2,600 participants were enrolled, as reported in the published paper. Enrollment targets were more often met and often exceeded. Running totals on invoices, reimbursements, and remaining balances for 75 industry-sponsored trials were also being more routinely tracked. 

One early success came from use of the platform by the OCR’s budgeting and invoicing team for a pair of COVID-19 vaccine trials that randomized 724 participants over a seven-month period. The financial viability of these resource-intensive trials was ensured by tracking recruitment-conditional invoices and their reimbursement, which totaled $6.1 million, Sampson says. 

Being an early adopter of the newly upgraded RINS, the HCC Clinical Trials Office (CTO) has hard evidence of return on the institutional investment, especially in terms of operations and recruitment, says Tricia Bentz, HCC CTO administrative director. The CTO leveraged OnCore task lists functionality to standardize trial start-up operations and reduce delays in study activation. When measuring the number of calendar days from scientific review committee submission to activation, a common benchmark among NCI Designated Cancer Centers, the CTO currently activates treatment trials 22% faster than before implementation of the task lists. 

The study information captured in OnCore was also vital to the creation of a new mobile device application that allows health professionals easy access to real-time cancer treatment trial information, Bentz adds. “Having clinicians know about our trial options at the time of patient treatment planning is an essential component to improving clinical trial recruitment.”  

Regardless of the kind of clinical research that is being done, says Sampson, the intent of the integrated CTMS/RINS is to help study teams maximize resources. In some cases (e.g., rare disease trials), patients may be inherently hard to find, or extra effort may be required to improve awareness and access as well as ease participation burdens. In other cases, the MUSC Health System may not have the right patient population based on the condition being targeted or the study’s inclusion/exclusion criteria, so the institution should be taking a pass on the opportunity altogether.  

The decision-making process needs to consider how many other overlapping studies are trying to recruit the same sorts of patients, she adds, as well as how interested investigators are in conducting a particular trial. A feasibility analysis, aided by TriNetX technology and Epic’s SlicerDicer tool, can determine if the requisite patient population for a study is being served by the MUSC Health System. 

For studies deemed to be a good fit, attention then shifts to staying on pace with targeted enrollment benchmarks, says Sampson. Historically, the only way of learning how many patients in the clinical enterprise were participating in research at MUSC and how many of those studies were meeting their enrollment goals required contacting individual study teams and asking for that information. Often, the data was documented on paper or an Excel spreadsheet.  

Go-Forward Plans 

The OCR is providing access to the CTMS/RINS platform in MUSC’s outlying rural divisions where clinical trials are now being conducted thanks to a Duke endowment grant supporting the research expansion, Sampson says. The first of these trials started in the Florence division during the early months of the COVID-19 pandemic, she says. 

Since the MUSC Health System falls within the 11-state “Stroke Belt” region with higher stroke mortality, cardiovascular trials are of particular interest. But the OCR will help MUSC PIs, wherever they may be, identify appropriate research opportunities and engage providers who already have a trusted relationship with an enrollable population.   

One of SCTR’s latest RINS projects is the creation of the study activation dashboard, which will help study teams track what has and needs to be done as well as alert them when something is required of them—e.g., a lab manual or updated consent form—to keep the momentum going, says Sampson. The idea grew out of consulting work by the University of South Carolina Darla Moore School of Business, Center for Operations & Supply Chain, as part of a recent capstone project.   

“Document management is another area that we really have to fix,” she adds. “Currently, study teams must upload protocols in an awards system, an IRB system, and a coverage analysis system (to determine if study procedures can be billed to third party payers like Medicare), which can result in three different versions of the protocol being reviewed and delaying study start up. This is another area that the CTMS can help us with.”   

The addition of a CTMS and associated services to support its adoption would not have happened without institutional willingness to make the financial investment, Sampson emphasizes. “Our goal is that all the systems we are using for research will [eventually] interface with each other, so we are not having the PI name entered into 24 different systems, potentially in 24 different ways.”