The Business Case For EHR eSource In Clinical Trials

In the words of one clinical research coordinator,

“Entire Monday mornings and the better part of afternoons – depending on the number of subjects on study that weekend – were dedicated to pulling data for the multiple subjects over multiple days.”

She went on to observe, “Most of this data already exists in the subject’s EHR but we wind up spending a lot of time to find that data and then copy it in the study’s EDC.”

There has to be a better way than the manual collection and abstraction of clinical data from medical records.

• It’s expensive.
• It’s a bottleneck.
• It’s further exacerbated by human errors that require additional investments in data cleaning and validation.
• It increases stress and burnout for clinical research coordinators.
• It lengthens the time required to acquire study data and increases the risk of comprised data.

I’m betting you intuitively know this, but if you’re the kind of person who needs proof, we have that too.

For the first four months of an adaptive platform trial of repurposed therapeutics for patients hospitalized with a severe infectious disease, a digital link between the EHR and the electronic data capture (EDC) system did not exist.

The introduction of eSource EHR integration at month four enabled the study sponsors to evaluate the impact. In short, there were massive time savings as well as a reduction of data errors and downstream costs associated with cleaning, source data verification (SDV) and validation.

As Amy MK Rovitelli, Critical Care Research Coordinator at the University of Rochester, shared:

“The switch from manual data entry to digital data transfer enabled hours of data collection work on some of the most tedious and I would argue probably some of the most queried data to be completely accurate in just minutes, reducing 60 minutes of manual entry into five minutes of downloading source data. The subsequent monitoring visits went so much quicker, and the number of queries dropped dramatically.”

To review the numbers, and dive deeper in the business case for EHR eSource, download the case study below.