The benefits of electronic clinical outcome assessment (eCOA) data collection are widely acknowledged, but it’s more than just cool technology that’s driving its global adoption. Here, Ron Sullivan, ERT’s Executive Vice President, eCOA answers questions about current eCOA trends and what we can expect from this valuable clinical research tool in the future.
What advantages does eCOA have over paper?
eCOA has repeatedly been proven to deliver higher quality data than the traditional paper-based approach. Some major advantages that eCOA data collection has over paper are that it:
- Prevents question skipping
- Expedites data collection with branching and logic
- Has time-stamping that makes it inherently attributable
- Overcomes the costs of paper-based data collection
- Reduces the time to manually enter data
- Minimizes errors that occur in manual data entry/reconciliation
- Enables more efficient data collection through integration with various medical and mHealth devices
Want to learn more about the advantages of eCOA data collection? Download our ebook “7 Reasons to Use eCOA”.
What eCOA advancements can we expect to further incite sponsors to abandon paper-based data collections?
Today’s eCOA data collection solutions involve more than just transposing a questionnaire onto an electronic device. We believe that eCOA advancements will urge others to abandon paper-based data collections for many reasons.
- The solution facilitates improved site workflow and efficiencies, e.g., utilizing a tablet for both clinician-reported outcomes (ClinRO) as well as patient-reported outcomes (PRO), inputting data from multiple avenues and analyzing data in real-time.
- We’ll also see further ‘back-end’ advancements that will enable sponsors to identify data outliers at the site and patient level, making eCOA more of a trial oversight solution.
- Lastly, we can expect to see more eCOA / device integrations (such as activity trackers as fall indicators in neurology studies or Alexa-style voice recognition for studies involving physically impaired patients) which provide greater insight into patients’ experiences during clinical development. Paper-based data collection simply can’t offer these valuable benefits.
What are some of the things sponsors need to consider when thinking about electronic implementation?
Although it may seem at first that eCOA data collection is disruptive to the traditional paper-based COA, eCOA is actually much simpler for both the patient as well as the investigative site. Sponsors who are currently transitioning from paper to electronic collection realize that it doesn’t have to be disruptive. By thinking about electronic implementation and processing during the protocol design stage, sponsors can realize a series of clinical advantages that enable them to achieve study power quickly.
What’s at risk for sponsors who aren’t yet adopting eCOA?
In the near future, one of two scenarios will occur: either regulators will set compliance standards or they will require evidence of real compliance – attributable, legible, contemporaneous, original and authentic. Sponsors using paper methods will find it is very challenging, if not impossible, to prove these attributes.
Global and regional regulatory authorities have been publishing eSource, ePRO, and eCOA guidances and reflection papers that will probably evolve to regulation at some point. Since history has shown that many regulators around the globe react significantly faster than the FDA and they don’t give sponsors much leeway when putting a new law in place, sponsors continuing to use paper COA collection risk finding themselves behind that curve.