Researchers at the University of Colorado Anschutz Medical Campus have partnered with UCHealth to pilot a streamlined way to conduct clinical trials that could cut down on costs, time and extra lab work, while enabling patients to more easily enroll in research studies.
“Clinical research is the way we drive discoveries, but cost, resources and accessibility can be a barrier,” said Thomas Flaig, MD, an oncologist and vice chancellor for research at the CU Anschutz Medical Campus. “We believe there must be a better, more efficient way to conduct these trials directly within the electronic health record and routine care.”
CU Researchers and partners at UCHealth collaborated to develop a first-of-its kind clinical trial that is conducted almost entirely electronically. The team recently launched a randomized pragmatic study to analyze how the drug metformin, typically used in the treatment of type-2 diabetes or for diabetes prevention, combined with lifestyle modification, affects prostate cancer and metabolic outcomes.
“This study gives researchers a new way to identify and approach potential trial participants,” said Cecilia Low Wang, MD, the study’s co-investigator and a professor of endocrinology at the University of Colorado School of Medicine. “Our unique approach allows researchers to screen the electronic health record for patients that fit the trial’s criteria. Participants can then opt in and receive study educational materials directly through their patient portal.”
Once a participant is enrolled, researchers can use data gathered during regular clinical visits to study the impact of metformin and factors like weight, exercise and blood pressure in addition to cancer survival rates. Unlike traditional clinical trials, the study largely avoids special visits or lab work, making it far less invasive and time-consuming for patients and providers alike.
“Our partnership with the UCHealth system is invaluable in making this happen,” said Flaig. “If successful, the experience gained from this pilot has the potential to significantly streamline the scientific discovery process for research teams nationwide, leading to faster answers to pressing scientific questions.”
As an integrated medical campus, CU Anschutz is uniquely positioned to utilize the electronic health record (EHR) in partnership with UCHealth to conduct clinical trials. The collaboration resulted in a new architecture to capture and cross reference data, streamlining information-sharing between the patients, providers and researchers. The threefold project goal – to augment the patient experience, care and clinical research – required significant collaboration, innovation and investment.
“This new capability was designed to be convenient and easy to use for patients, physicians and researchers. Even with these very complex uses, simplicity and seamlessness is always the goal,” said Steve Hess, UCHealth chief information officer. “Additionally, the team always focuses on how we can scale our solutions. We anticipate we can use the design to meet other research needs moving forward and impact many more patients.”
To develop the trial, the research team sought input from the Institutional Review Board (IRB) and campus partners to develop an ethical study design and ensure compliance with FDA regulations and best practices in electronic health records (EHR). The pilot will help to determine if this novel approach is feasible, as well as the scalability and resources needed for future EHR-based research studies.