The benefits of electronic clinical outcome assessment (eCOA) data collection are widely acknowledged, but it’s more than just today’s advanced technology that’s driving its global adoption. Here, David Elario, 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 do you feel is the single most important benefit electronic data collection brings to clinical trials today?
Without a doubt, I’d say that the greatest benefit of capturing data electronically is the ability to improve data quality compared to traditional, paper-based methods. A growing majority of clinical trial stakeholders including sponsors, CROs and regulators consider eCOA to be the most effective way to capture high-quality and reliable clinical trial data. It’s been proven time and time again that collecting data electronically:
- Improves patient compliance (Figure 1)
- Prevents inconsistent or conflicting data
- Eliminates illegible answers
- Eliminates transcription errors
- Meets global regulatory standards
What about clinical trial efficiencies. How are today’s eCOA solutions helping drive study efficiencies for sponsors?
Today’s eCOA solutions are continuously evolving to further boost trial efficiencies for study sponsors and CRO’s. For example, we’re seeing site personnel using one tablet for both clinician- and patient-reported outcomes (ClinRO / PRO), eCOA devices capturing data from multiple medical and consumer devices and sensors, and algorithms being used to flag erroneous/incorrect data so that sponsors can ultimately analyze data in real-time. All of this helps to reduce the time and costs needed for clinical trial data collection and analysis. Ultimately this technology is helping speed up trials and bringing new drugs to market faster.
Where do you see growth coming from in the collection of eCOA data?
I expect to see many more sponsors and CROs deciding to switch from paper collection to more compliant and reliable electronic data capture solutions for both PROs and ClinRO. Regulatory authorities such as the FDA and EMA clearly recognize the benefits of electronic data capture.
Let’s take an example. Oncology trials represent 30% of all clinical trials conducted globally. ePRO is increasingly becoming an important aspect in oncology drug development and much of this comes from the FDA recommending the collection of secondary endpoint data to measure quality of life, as survivability endpoints are no longer enough to justify market differentiation.
Finally, Dave, what future innovations will drive further adoption of eCOA?
Backend eCOA advancements will enable sponsors to identify data outliers at the site and patient level, making eCOA much more of a trial oversight solution. I also envision continued eCOA integrations with many other devices and biosensors as the Internet of Things expands. Here I’m talking about, for example, activity trackers and fall indicators. When data gathered by these devices are added to data submitted by the patient, clinical trial sponsors gain better insight into the context of the data and better visibility into patient experiences while on therapy.
On the frontend, I see the use of BYOD [Bring-Your-Own-Device] expanding so patients will use their own cellphones and tablets– and soon, voice technologies such as Siri, Alexa, and Google Assistant.
Most of these innovations are already in development and will undoubtedly enable sponsors to operate more efficiently, improve patient recruitment and retention, and capture higher quality COA data.
David Elario is the Executive Vice President of eCOA at ERT.