The Pragmatic Research and Trials Core was announced earlier this summer to expand support services for faculty on the University of Colorado Anschutz Medical Campus. R. Mark Gritz, PhD, associate professor in the Division of Health Care Policy and Research at the CU School of Medicine and ACCORDS director of operations, will lead the new core within ACCORDS.
“We have a wide variety of pragmatic research and trials going on across ACCORDS and on campus, so we have significant experience doing this work, as well as a campus-wide need,” Gritz says.
The core will assist investigators seeking advice and guidance related to pragmatic research and trials in real-world settings that need to consider perspective in the design and conduct of their research or trial. This real-world research takes place in the community, often in clinics or involving health care policies. The group will also help investigators identify and navigate additional consultations they need for a successful pragmatic study.
“I view this new core being most beneficial to junior investigators who are interested in pragmatic research and trials or more experienced investigators who are moving along that continuum toward a pragmatic type of design,” Gritz says.
The controlled to pragmatic continuum
In research and trials, investigators follow a continuum from controlled to pragmatic. The primary focus for a highly controlled setting is seeking internal validity. For example, when comparing study outcomes between two groups, the difference in results can be attributed with high confidence to the intervention being tested. On the pragmatic side, the primary focus is external validity. A pragmatic research study or trial looks to discover the effect or impact of an intervention in a real-world setting.
Similar to the Learning Health Systems Core, which ACCORDS also launched this summer, the Pragmatic Research and Trials Core will leverage expertise from existing ACCORDS cores.
“These new cores are more broadly applicable to a range of research and trials and involve almost all of our methodological cores,” Gritz says. “With the pragmatic approach, we must ask, ‘What does this mean in the real world?’ and ‘What do we need to help investigators be successful at conducting pragmatic research and trials?’”
The new core will help investigators assess and understand where they are along the controlled to pragmatic continuum, what types of issues may arise, and whom they can collaborate with at CU Anschutz.
Navigating pragmatic clinical trials in conjunction with CCTSI
The Pragmatic Research and Trials Core will closely collaborate with the Colorado Clinical and Translational Sciences Institute (CCTSI) Pragmatic Trials Navigation Service, led by Bethany Kwan, PhD, MSPH, associate professor of emergency medicine and CCTSI director of dissemination and implementation research. In addition to the Pragmatic Trials Navigation Service, CCTSI offers a Pragmatic EHR-Embedded Trials (PEET) research program.
“We’re not going to duplicate work. We're going to work collaboratively with the CCTSI on consults,” Gritz says. “If a consult request comes into ACCORDS and it fits within the PEET, my goal is to help direct investigators to the resources on campus that are best going to maximize their likelihood for having a successful project or study.”
The two centers work in partnership to navigate existing research consultations and grant awards. If an ACCORDS investigator needs help to write a K award proposal, they are referred to CCTSI, as they have a program for mock review sessions for these types of research career development awards. The reverse is true of a CCTSI investigator who requires an economic analysis component to their trial referring them to the ACCORDS Economic Analysis core. Gritz anticipates the Pragmatic Research and Trials Core will further the collaboration through alignment with the Pragmatic Trials Navigation Service.
“We can think of this as ‘No Wrong Door.’ No matter which door a person comes through, we can help get them aligned with the resources on campus that are going to make for the best project they can do,” Gritz says. “I'm viewing this as going beyond just ACCORDS and CCTSI.”
