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Applied Clinical Trials
By leveraging EHR data, the industry can transform how it conducts clinical research and delivers health care in the future.
Though the comprehensiveness of electronic health records varies globally, EHRs contain a wealth of longitudinal real-world data-including demographics, clinical data, pharmacy and billing claims, and other patient information-to create a multifaceted picture of health, care-seeking behaviors and pharmaceutical consumption across broad populations. By leveraging EHR data, the industry can transform how it conducts clinical research and delivers health care in the future.
Identify qualified patients for clinical research
Prescreening individuals according to specific demographic and medical data can expedite the patient recruitment process in clinical trials. Jeff Wendel, President of Advarra, articulates EHR’s wide-ranging potential: “The ability to mine information in EHRs will allow us to identify potential patients, expose them to the opportunity of participating in research, and then connect them with physicians they may be familiar with, including their own physician.” EHRs can help identify, reach, and serve a broader patient population, to benefit the patient and further research.
Optimize patient safety
Changing the current mindset to advance health care requires a bridge from EHR data into clinical trials, according to Jeff Beeler, solution executive at IBM Watson Health. Without the integration of data from electronic records, he says, the disparate data will not be as robust and complete. For example, in a clinical trial, patients may inadvertently fail to report information such as an adverse event. By unlocking pharmacy and claims data as well as other information from electronic records, however, clinical researchers can help ensure patient safety and identify whether treatments result in improved health outcomes.
Streamline reporting and data capture
In “Overcoming Challenges to Using EHR Prospectively for Clinical Research Studies,” Rebecca Kush, PhD, Scientific Innovation Officer at Elligo Health Research, discusses how the use of EHRs resulted in significantly faster drug-related adverse event reporting-from 35 minutes to less than one minute. In addition, using EHRs to auto-populate electronic case report forms, as opposed to manual data entry, resulted in time savings of 37 percent for data capture. The potential for EHR to improve efficiencies in clinical trial conduct is vast, and these recent studies have made strides in quantifying the ROI.
Bridge clinical research and health care
The data in electronic health records overlaps with the types of data collected for clinical research. This provides opportunities for data sharing and reuse without reentry or transcription, thus supporting open science and learning health systems. Building better bridges between research and health care offers limitless possibilities for facilitating research and improving health care delivery.
Komathi Stem, MSE, founder and CEO of monARC Bionetworks, speaks to the possibilities: “The sheer tsunami of health care data available from medical records and the growing use of mobile and digital sensor technologies to collect health data, combined with rising online patient engagement in health care and research, present an unprecedented opportunity to modernize clinical trials through greater collaboration with patients and their clinical care systems.”
Data harmonization and next steps
To unlock, access, and leverage the multitude of data from EHRs requires harmonization of data standards and data models. TransCelerate’s Clinical Data Standards Initiative, in collaboration with the standards development organization, CDISC, as well as C-Path, NCI-EVS and FDA as part of CFAST, aims to develop industrywide data standards to support the exchange and submission of clinical research data. The implementation of these standards will enable data aggregation, cross-study analysis and end-to-end data flow, as well as facilitate analysis from multiple disparate data sources. Consistent data collection in clinical trials will ultimately lead to more efficient research with higher-quality data.
Regulatory guidance on using EHR and applying artificial intelligence to enhance patient recruitment are also key issues to explore to advance the state of clinical research. Through collaboration between multiple stakeholders-including pharma, biotech, CROs, health care organizations, advocacy groups, and regulatory agencies-we can ultimately develop solutions to the industry’s most critical questions.
Joan Chambers, Senior Strategic Advisor; Naomi Fujimoto, Senior Copywriter, both with SCORR Marketing and Bridging Clinical Research & Clinical Health Care Collaborative