Traditional enrollment methods for clinical research are often manual, time-consuming and expensive, so shifting to an electronic process can accelerate recruitment while reducing costs.
Across the country, an estimated 80% of clinical trials are in jeopardy of being delayed or closed due to enrollment issues. Research project timelines are often doubled to meet enrollment goals, and nearly 40% of the total clinical trial budget is used for enrollment.
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At Cleveland Clinic, research leads estimate that study coordinators spend up to 25 hours each week identifying, contacting and recruiting potential participants. Even with this time commitment, studies are often still at risk of under-enrollment.
The same recruitment challenges impact research projects dependent on biospecimens collected from patients during their clinical care; a vital component to advancing personalized medicine.
“With these ongoing obstacles, there’s a natural progression to use technology to expand our recruitment capabilities,” says Lara Jehi, MD, Chief Research Information Officer (CRIO). “It becomes a question of why not? Why not have research keep up with the technology we’re using in every other aspect of our lives?”
Looking to accelerate recruitment efforts, Dr. Jehi worked with several teams* to develop a collaborative and comprehensive electronic health record (EHR)-based strategy.
While Dr. Jehi sees technology opportunities throughout all phases of clinical research, she also knows governance and processes are equally important.
“As CRIO, I’m responsible for data governance for research,” she explains. “When I stepped into this role, my initial priority was to establish clear guidelines on the processes of collecting, sharing and accessing data.”
Dr. Jehi worked with a diverse group of internal stakeholders and patients to create Cleveland Clinic’s data guidelines. These guiding principles help define the governance structure needed for specific research projects.
Dr. Jehi continues, “Governance is imperative to maintaining patient privacy and protecting their health information, particularly when electronic tools are used for research purposes. We adhere to a rigorous vetting process to avoid overburdening our patients.”
This process has given Dr. Jehi a heightened appreciation for being a good listener. “Research needs to work in tandem with clinical care. By listening to the study team, we can turn potential into reality. Our best outcomes stem from a shared understanding of everyone’s perspective.”
These conversations have also led to enhanced communication, streamlined resources and improved processes.
“Each research project is a journey,” notes Dr. Jehi. “The roadmap includes a collective understanding of the study team’s needs and where we can add value. Together, we can explore innovative opportunities that we didn’t think were possible.”
Enhancing technology’s value comes with governance and sustainable processes.
For Dr. Jehi, that means focusing on the bigger picture. She notes, “Technology alone is not the answer. With a broader view, there’s an increased focus on the essential components needed for success.”
Two recent initiatives illustrate this important perspective.
Enhanced electronic health record (EHR) portal recruitment: Under the governance of the Cleveland Clinic Information Technology Research Committee, study teams can use EHR-based tools to expand their recruitment reach to larger patient populations through the EHR portal. While this is a more standard approach, the study team follows specific processes to meet internal and regulatory guidelines. With EHR recruitment, 949 patients were enrolled for interventional studies from 2020-to 2021. As a comparison, traditional enrollment yielded less than 10 patients/study annually; whereas, EHR enrollment brought more than 100 patients/study.
Expanded biorepository collection: An EHR-based digital infrastructure was developed for biospecimen collection. With guidance from the BioRepository Steering Committee, study teams have access to technology applications and EHR-based tools to expedite patient identification, electronic consenting and sample collection into the clinical workflow. With this new process, 1,172 participants were enrolled and 3,565 blood and cardiac tissue samples were collected in 2021 from Cleveland Clinic Heart, Vascular and Thoracic Institute procedures. This accelerated recruitment within one year represents a 20-fold increase with a five-fold cost reduction.
Dr. Jehi concludes, “This tremendous growth was only possible with the support, time and input from multiple teams. With our shared vision, we will continue to seek opportunities that will further bridge research and technology into innovative care.”
*Cleveland Clinic teams supporting these initiatives: Center for Clinical Research, Lerner Research Institute, Information Technology Division, Pathology and Laboratory Medicine Institute, Heart, Vascular and Thoracic Institute, Anesthesia Institute, Enterprise Analytics, Institutional Review Board, Law Department, Compliance Office and Office of Patient Experience.
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