Beyond the Pandemic: Why eCOAs are here to stay

Electronic Clinical Outcome Assessments (eCOAs) were already an essential and fast-growing part of clinical research prior to the pandemic. eCOAs are digital tools that sponsors use to remotely capture patient experience data, giving sponsors the ability to obtain near real-time data and access to study trends. These tools brought new data and insights to the research landscape while reducing the data collection burden for patients and site staff.

During the pandemic, when patients could no longer visit trial sites, eCOA quickly became the ‘go to’ measure for collecting patient data in vaccine trials and helped sites maintain compliance through the crisis. These electronic tools are being used to track patients’ drug and protocol compliance and monitor the quality of life measures and the day-to-day behavior conditions.

This experience showed sponsors and sites just how valuable eCOAs can be over paper data collection. The constant, real-time flow of data brings many key benefits to trials that go beyond crisis mitigation:

Deliver almost instant access to patient data, which accelerates sponsors’ ability to identify trends and make decisions.
Provide a constant flow of data rather than a single snapshot in time, which gives sponsors and investigators a more robust picture of the patient’s condition over time.
Ability to alert investigators to issues in real-time, lowering the potential impact of some adverse events, and accelerating response for patients in need.
Bolsters the verity of the data because patients report outcomes as they occur, rather than weeks later at a clinic appointment.
Eliminates manual data transfer tasks, cutting time and cost from the trial and reducing potential for errors.

These benefits were always part of the eCOA value proposition, but for sponsors slow to adopt eCOAs as part of their trial process, their use during the pandemic has been eye-opening. Now that investigators and sponsors see how easy it is to gather more data, faster with fewer related tasks, and less burden to patients, they aren’t likely to give that up.

Along with the time and potential cost savings, the permanent adoption of eCOA is a natural step in the industry-wide effort to create a more patient-centric clinical trial experience.

eCOA tools reduce the burden of participation for patients while increasing the quality and quantity of data that investigators capture in their treatment journey. Additionally, they amplify the patient’s relevant information -- such as: how they feel, whether they can participate in physical activity and whether they can return to work and other activities. These tools highlight the quality of life measures and provide sponsors with data about how treatment impacts life quality while maintaining the integrity of trials. These data points are becoming increasingly important to regulators as part of the approval process and may impact prescription and adherence trends.

Going forward, eCOA and other direct-to-patient technology options will only get more sophisticated, bringing a steady stream of useful data to the trial environment. The current generation of mobile phones and commercial devices already make data collection a seamless part of patients’ lives. These devices capture important health and well-being data from patients remotely with no effort required through gadgets such as watches that count steps and track heart rates to continuous glucose monitors.

Patient centricity goes digital

While virtual trials reduce the need for on-site visits for patients, many trials will still require patients to attend site visits at certain points through the duration of the trial. However, integrating eCOAs into the trial design can make those visits less frequent. This reduces the travel burden, which can help bolster recruiting and retention goals.

When patients come to trial sites, investigators can use that time to have more meaningful conversations about the treatment and answer questions about their experience – rather than capturing PROs. This will make these visits more valuable for everyone involved.

And if another crisis occurs that shuts trial sites down again in the future, investigators and sponsors will have the experience and confidence to leverage eCOA technology to keep their trials on track. Interestingly, it took a pandemic forcing patients to stay away from the clinic to prove digital tools can humanize the trial experience. eCOAs may require less face-to-face interactions, but they make the trials easier and more engaging, which is critical to creating a more patient-centric experience.

eCOA and other digital health tools were well suited to accommodate the rapid rise in virtual and telehealth shifts due to the pandemic. And there’s no going back. These will continue to be an integral part of the clinical trial environment moving forward – ultimately benefiting all who are involved in bringing new therapies to market from sponsors to individual patients.

To learn more about how to use an eCOA in your next clinical trial, reach out to an IQVIA eCOA expert at ecoa@iqvia.com.

eCOA

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In these short demo videos, learn more about some of the key capabilities within the IQVIA eCOA platform including how to easily create an assessment, utilize the AI design tool, access automated screenshots and documentation, export/import translations, and view study data and reports.

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