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FDA Issues Final Guidance on Integrating EHR Data in Clinical Studies

by Hugh Levaux, on Aug 22, 2018 8:23:20 AM


The greatest innovations throughout history caused a game-changing shift in industries generally stuck in their ways. The invention of email put peer-to-peer communication into hyper speed. Similarly, the printing press streamlined mankind’s ability to document and distribute information, paving the way for knowledge to be shared across the globe.

In the clinical research space, improvements to EHR and EDC systems may not provide the same world-altering changes as the examples above, but they are providing a new shift in the paradigm, by making trials more cost-efficient and drastically reducing timelines. By streamlining the data entry process, we now have the ability to reduce operational redundancies and almost completely eliminate transcription errors too. The problem is, due to long-held objections against EHR data quality, coupled with slow adoption of new technology, these benefits have yet to permeate clinical research.

The FDA released new guidelines last month, calling for sponsors and CROs to embrace new technologies which increase the collaboration between EHR and EDC, in order to improve overall trial accuracy and efficiency.

Use of Electronic Health Record Data in Clinical Investigations (FDA Procedural Guidance for Industry, July 2018)

The FDA first published a draft of the now finalized guidelines in 2016, providing recommendations to sponsors, clinical investigators and CROs on expected EHR data use in clinical investigations. The guidelines provide recommendations and best practices to:

  • Promote interoperability between EHR systems and EDC systems
  • Relay the FDA’s expectation of how and when EHR systems should be used
  • Ensure the data collected is kept to the highest standards of quality and integrity
  • Ensure that EHR data collected meets all inspection, recordkeeping and retention requirements

While EHR systems themselves are not directly regulated by FDA, it’s clear that the agency believes they are the way of the future. The FDA’s goals, "…are to modernize and streamline clinical investigations through the use of EHR data and the inclusion of real world data in clinical investigations.” Technology has made what sounded far-fetched two years ago actually possible, and we believe that the FDA is nudging the industry in the right direction – towards a more ideal environment.

The Case for Interoperability

The most significant message from the FDA is promoting compatibility between EHRs and EDCs. Their guidance recommends the exchange of structured data between the two systems, so that data can be entered once at the point-of-care and accessed without unnecessary, redundant and time consuming manual double entry or source data verification.

“Every clinical use of a product produces data that can help better inform us about its safety and efficacy,” said the FDA’s Jacqueline Corrigan-Curay, director of the Office of Medical Policy in Center for Drug Evaluation and Research. “The FDA is committed to developing policies and tools to help researchers access and use data collected from all sources to support a finding of safety and efficacy.”

By urging for EHR and EDC interoperability, the FDA is making it clear they want to see an increase in efficiency and innovation in clinical trials.

EHR systems have made major strides in data quality over the last decade, a lack of interoperability with EDC systems has been the one perceived deterrent preventing wide scale adoption. That’s where Clinical Pipe (CP) comes in.

CP is a first-in-class, stand-alone, system-agnostic adapter, connecting any EHR to any EDC. Rather than your sites manually transcribing EHR data to EDC, it’s automatically transferred with just a few clicks.

On top of its ease-of-use and simple integration (we can configure an entire eCRF casebook and the associated EHR mappings in as little as a day), CP is 21 CFR Part 11 compliant and meets HIPAA and related patient privacy standards.

What this all adds up to is an EHR to EDC integration app that checks all the boxes laid out in the FDA’s guidance. Tapping into the power of EHR to EDC interoperability with CP streamlines data capture, resulting in zero redundancy, expedited timelines and reduced costs.

A Change in the Industry

The FDA’s efficiency-focused guidelines come at a time when the effect of drug prices on consumers is making for some unfavorable headlines.

Public outrage and government scrutiny regarding drug prices has never been higher. Feeling the heat, the likes of Pfizer, Merck, AZ, Novartis, Novo Nordisk and Sanofi have announced an unprecedented pledge to cap increases in drug prices in the U.S. for at least the next year.

We applaud this pledge taken by Pharma leaders and see it as a move in the right direction for the industry. However, if the pricing cap and its goodwill are to be maintained, then all industry stakeholders need to find ways to decrease operating costs, in an effort to curtail price increases without effecting the bottom line.

By ensuring fewer redundancies, accurate data capture and shorter timelines, CP’s streamlined process will help our customers achieve cost savings without sacrificing care to their research subjects and study participants.

We’d love to tell you more about Clinical Pipe and our vision for the connected future of EHR and EDC systems.

Set up a Demo today! REQUEST DEMO



Topics:EHRClinical StudiesFDA