Clinical trials are vital to the health care system. They help translate lab discoveries into real-world changes that improve the lives of patients. But they don’t happen in a vacuum. These trials require teams of established investigators, communication across multiple research sites, and a network of ultra-organized staff who contribute expertise in study design, database development, data management, quality assurance, reporting, statistical analysis, and technology support.
“Supporting clinical trials can be a big job,” says biostatistician Kathryn Colborn, PhD, MSPH, professor of health care policy and research at the University of Colorado Anschutz Department of Medicine, who directs the data coordinating center (DCC) of the Data Informatics and Statistics Core (DISC) at the Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS) and the DCC for the new campus clinical trials initiative.
As the CU Anschutz School of Medicine accelerates its focus on clinical trials, Colborn’s role as DCC director continues to serve a vital purpose for research collaborators on campus and at other academic research institutions across the country.
“You really must have a handle on key components of study design, helping people choose how they're going to approach their study, data management, and quality monitoring. Where are we going to keep the data? How are we going to collect the data? These are things we think about,” Colborn says. “At ACCORDS, we have 15 data analysts and five PhD biostatisticians, and we support multi-site trials by helping investigators with the design, building electronic databases for data collection, performing quality monitoring, analyzing data, and more.”
Among Colborn’s current focus areas include a consortium on palliative care based at CU Anschutz, a Patient-Centered Outcomes Research Institute-funded DCC for a phased large award for comparative effectiveness research (PLACER), and efforts to build capacity to support DCC work for more clinical trials.
Last August, the CU Anschutz School of Medicine was selected as the prime award institution for a $64 million award from the National Institutes of Health (NIH) to establish a consortium focused on palliative care research. The consortium, called the Advancing the Science of Palliative Care Research Across the Lifespan (ASCENT) Consortium, is being led by Department of Medicine Distinguished Professor Jean Kutner, MD, MSPH, and will feature additional principal investigators (PIs) from four other academic centers across the country and more than 40 key personnel from 20 institutions.
Kutner says this interdisciplinary approach is integral to palliative care. To achieve the consortium’s goals, Colborn and her team are stepping up.
For a decade, Colborn has co-directed the DISC of the Palliative Care Research Cooperative Group (PCRC), an interdisciplinary research community made up of more than 600 members across the country. ASCENT grew from this community, and while Colborn and her team don’t need to build databases or oversee regulatory compliance for the consortium, “we do have tools that we’re trying to bring together for investigators across our network that they can utilize in their studies,” she says. “That’s where the common data elements and data repository come in. In this case, the DCC is about being a resource to the community.”
The CU Anschutz campus has over 3,800 active research studies with more than 15,000 people participating in them, and while not all studies require a DCC — various factors, including U.S. Food and Drug Administration regulations, can influence the need for one — a growing commitment to multi-site clinical trials means the DCC will be an important piece of successfully executing these research endeavors.
The work is lively and almost every project is a little different, Colborn says. It allows her and her team to continuously learn new things, from what species of mosquitos transmit different pathogens to the types of interventions that are most successful for improving quality of life in cancer patients.
“It’s rewarding to know so many people across this campus and be able to help them,” Colborn says. “We wouldn't have anything to do if there weren't these awesome clinical research coordinating teams. They find the patients, recruit them, tell them about the study, help them complete the clinical research forms, and take all the biological measurements.
“The clinicians and the PIs are of course critically important, as they design and lead the studies,” she adds. “Multi-site studies are the ultimate form of team science. Their success relies on each person to do great work.”