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New Policy Will Help EHRs Improve Clinical Studies: 5 Things to Know


FDA’s new guidance provides a roadmap for health executives on incorporating EHRs into clinical trials.



Healthcare executives now have a roadmap to incorporating EHRs into clinical trials and product submissions, including use of patient medical histories and pharmacy records, with FDA’s issuing of a new policy.

According to the FDA, with the widespread use of EHRs, there are opportunities to improve data accuracy and promote clinical trial efficiency when EHRs are used in clinical investigations. “EHRs may enable clinical investigators and study personnel to have access to many types of data (e.g., clinical notes, physician orders, radiology, laboratory, and pharmacy records) that can be combined, aggregated, and analyzed. EHRs may have the potential to provide clinical investigators and study personnel access to real-time data for review and can facilitate post-trial follow-up on patients to assess long-term safety and effectiveness of medical products,” according to the FDA.

The guidance also encourages stakeholders to work toward interoperability between EHR and electronic data capture (EDC) systems, as well as makes non-binding recommendations on:

  • When and how to use EHRs as a data source in a clinical investigation.
  • How to use EHRs that are interoperable with EDCs in clinical investigations.
  • How to ensure the quality and integrity of EHR data collected and used as electronic source (e-source) data in clinical investigation.
  • How to ensure that the use of EHR data collected and used as e-source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirement.

It also fulfills a requirement set by the 21st Century Cures Act to issue guidance on real-world evidence in regulatory decision making, according to Art Papier, MD, practicing dermatologist and CEO of VisualDX, a healthcare informatics company.
“The 21st Century Cures Act requires FDA to develop a framework on how to evaluate real-world evidence and to issue a guidance about the use of real-world evidence in regulatory decision making,” Papier says. “From 21st Century Cures Act, this framework is focused on real-world evidence data to support approval of new indications or to satisfy post-marketing safety studies-so not for first approval of a new chemical or biological entity. Issuing this EHR guidance gets FDA a little closer to these goals.”

Real-world data and real-world evidence are not the same thing, according to Papier, “so this guidance helps stakeholders understand the FDA’s thinking on how real-world data from EHRs can become real-world evidence to support regulatory decision making-how to ensure the real-world data is sufficiently robust for clinical investigation. Although regulators are still focused on standardized data, they are now also giving attention to standardized approaches for collecting, evaluating, and analyzing data from untraditional sources,” he says.

According to Papier, this is a very important step that:

  • Enables a more direct relationship between clinical research and healthcare services and potentially expands access to clinical research for patients and clinicians.
  • Supports the use of EHR data in clinical investigations and promotes standardization of clinical data to support interoperability and data exchange between systems.
  • Offers important recommendations around data standards that can help ensure acceptability of EHR data collected in clinical investigations.
  • Indicates that there is in fact a pathway for EHR data to be used in regulatory decision making.
  • Offers the potential to look at a more complete (although not perfect) picture of the health of a patient and conduct better science toward the ultimate goal of improving public health.

“In addition to mining real-world data from EHRs, there is also momentum to make trials less burdensome on patients by enabling a more real-world experience through clinical trial participation in their local communities,” Papier says. “Virtual trial companies like Science 37 are leveraging telemedicine to bring trials to patients in their homes. This model reaches a more diverse demographic of patients who would not otherwise have access to join a trial while also enabling data collection that is more representative of the real world.”

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