Benefits, Challenges of Using EHR Data for Clinical Research

BENEFITS OF EHR DATA IN CLINICAL RESEARCH

A recent JAMA op-ed written by Elham Hatef, MD, MPH, from the Johns Hopkins School of Medicine and Bloomberg School of Public Health, highlighted the superiority of EHR data for clinical research.

Conducting surveys requires manual data collection, which is burdensome and limits the data to a select group of people. Additionally, claims data is not always accurate as it is often subject to lag time from the date the provider submitted the claim to the date the claim is fulfilled.

"The use of real-time EHR data on a large population of patients, compared with the use of survey data with limited scope and claims data with the time lag, provides a source of high-volume data, the potential of which has not been fully exercised in health care systems," Hatef emphasized.

Hatef noted that the use of real-time EHR data can help support health equity research. For instance, previous studies have found a link between food insecurity and hypoglycemic events in patients with diabetes. However, these findings were limited to the direct screening of food insecurity among a select number of patients.

A recent study leveraged EHR data to examine the association between neighborhood food environment and the risk of incident type 2 diabetes across different community types, Hatef referenced.

The researchers linked the individual-level EHR data and neighborhood-level attributes with the food environment, including the proportion of total food-serving establishments that were fast-food establishments and the ratio of the total retail food outlets that were grocery stores.

Ultimately, the study found that the neighborhood food environment was associated with increased type 2 diabetes risk among veterans in multiple community types.

CHALLENGES TO EHR DATA USE FOR CLINICAL RESEARCH

A recent study published JAMIA noted several challenges to using EHR data for clinical research.

Study authors collected survey responses from the research teams of 20 pragmatic clinical trial (PCT) projects, which leverage existing data streams in EHR systems and usually involve multiple clinical sites with broad eligibility criteria to generate real-world evidence.

Based on the survey responses, researchers found that PCT project challenges revolved around a lack of structured data collection and data standardization and aggregating data across sites.

The researchers explained that using EHR system data takes effort and detracts from other health system priorities. Yet this fact seems "fundamentally unchangeable," so the alternative is to change the argument for customizable EHR systems.

"The story needs to not be about promoting research per se but rather about finding and implementing the best and most effective treatments, and continuously learning within and across health systems," the study authors wrote.

However, building the infrastructure for reusable EHR data collection in support of continual learning does not come without costs.

"It is the joint responsibility of funders, researchers, healthcare systems leaders, EHR vendors, and policymakers to work together to accomplish these goals," the researchers argued.

The study authors suggested that research stakeholders promote standards-based EHR systems to health system leaders as a necessary enabler for integrating real-world evidence-based practices to improve healthcare quality and outcomes.

However, EHR systems are usually not standardized. Of the 21 trials studied, 16 used different data sources, which creates an ongoing challenge for investigators conducting PCTs.

Clinical and health services researchers should spearhead efforts to develop and promote standards for data interoperability in support of clinical research, the authors noted.

DEIDENTIFIED EHR DATABASES

EHR vendor Cerner recently announced the launch of a new operating unit, Cerner Enviza, which aims to offer data-driven solutions and research services to advance the clinical research process.

"The true promise of the digital age is to use data to improve everyday health around the world," Cerner President & CEO David Feinberg, MD, noted in a press release at the time of the announcement.

"Healthcare is far too complex, inefficient and expensive," he continued. "We have to break down industry silos and evolve from simply accumulating data to generating meaningful insights that can accelerate therapy development."

The EHR vendor's new operating unit will also focus on broadening the availability and participation in clinical research trials. A recent study revealed that only 3 percent of physicians and patients participate in clinical trials, and only a fraction of eligible patients ultimately receive the new treatments, Cerner officials noted in the press release.

The launch of Cerner Enviza comes after the EHR vendor recently announced that Children's Health of Orange County (CHOC) has joined its Learning Health Network (LHN) to advance pediatric clinical research.

Launched in early 2020, the EHR vendor's LHN comprises a diverse group of 74 diverse health systems that are helping to fuel Cerner Real-World Data (CRWD), a national de-identified dataset including 88 million patients and 786 million clinical encounters.

The design of the nationwide network of de-identified patient health data helps health systems access representative data and research resources to accelerate clinical research and trials.

"We're thrilled to welcome CHOC to the Cerner Learning Health Network," Christy Dueck, Cerner vice president of real-world data and clinical research, said in a public statement.

"The LHN has the potential of bridging the clinical research disparities that exist today for children," Dueck continued. "It is significant to have pediatric healthcare systems like CHOC join us to advance this cause and help accelerate the discovery, development, and deployment of groundbreaking insights and medicines."

Health IT vendors PRA Health Sciences, Inc. and Veradigm have also partnered to create an EHR-based clinical research network similar to Cerner's that extends the clinical trial process into EHR workflows.

Representatives said the benefits of the network are two-fold; patients will have greater access to CRAACO, which will lead to more diverse clinical trial participation.

"The current approach to clinical trials is disconnected from healthcare delivery and requires manual data collection, which creates barriers for physicians and patients to participate," Stephanie Reisinger, vice president and general manager of Veradigm's Life Sciences Research business, said in a press release at the time of the announcement.

The network will also aid clinical trial sites and sponsors by simplifying two of the most lengthy and costly clinical trial stages: data management and monitoring.

Most of the data needed for these clinical trial stages already exists in EHR systems, representatives noted.

PRA's health IT allows for automated data transfers from Veradigm's EHRs to an electronic data capture system. Access to this data allows clients to cut back on administrative burden and mitigate transcription errors without the need for costly source data verification.

Ultimately, the vendors hope this network will lead to improved data quality and a more efficient clinical trial process from start to finish.

"Integrating clinical research and clinical care is the model for achieving the best patient outcomes and for lowering costs for sponsors, physicians, and patients alike," said Kent Thoelke, executive Vice President and Chief Scientific Officer, PRA Health Sciences.

"With this partnership and network, we are leading the industry by expanding clinical research as a care option (CRAACO) to patients who have never had an opportunity to participate," Thoelke continued. "We are evolving and modernizing the drug development paradigm by integrating it with everyday healthcare delivery."

The continued expansion of learning health networks and the implementation of data standards are expected to advance clinical research as researchers continue to look toward EHR data to fuel their studies.