So You Want Your Trial to be More Patient-Centric? Here's Why an eCOA is Best for That

Anyone who’s been involved in clinical research knows that hand-written patient assessments can be an important but frustrating part of the data collection and analysis process for both the patient and the sponsor.

Gathering patient reported outcomes through these assessments or diaries ensures the patient perspective is recorded as part of the trial data environment. It also gives sponsors relevant insights into patient behavior as well as the influence and efficacy of the treatment. But the manual methods often used to capture this data are cumbersome and rife with problems.

When trials use paper-based assessments, they direct patients to complete them at key points in their treatment journey. That may include daily summaries of how they are feeling or recording quantitative or qualitative measures timed to relevant moments in the day.

Patients are expected to complete the assessments legibly and in accordance with a pre-defined schedule – but patients don’t always follow the rules. In many cases, they fill them out all at once, sometimes in the parking lot outside their next trial appointment. Or worse, they neglect to fill them out altogether. This approach can create holes in the clinical trial database, delay sponsors’ access to the data, and make this already subjective information less reliable.

Electronic Clinical Outcomes Assessments (eCOAs) can solve many of these challenges.

eCOAs transform the paper-based assessment into a real-time digital tool that collects insights directly from the patient about their disease, the trial experience, and the treatment’s impact on their quality of life. This brings several immediate benefits.

The data is captured electronically. This eliminates the need to transcribe handwritten data into a digital database – saving site staff hours of manual labor and eliminating the challenge of trying to decipher handwritten notes.
The data is collected sooner. Patients can complete their diaries online or offline, and as soon as they submit their data, it is uploaded to the trial database. This means sites and sponsors get near real-time insights into the patient experience, rather than waiting weeks for diaries to be submitted and entered at the site. This accelerates sponsor’s access to data, which can lead to a safer patient environment and faster results.
It creates accountability. IQVIA’s eCOA platform sends reminders and alerts prompting patients to complete survey questions on schedule and can let site staff know if patients consistently fail to meet requirements. This creates a culture of accountability for patients to record data as it happens, rather than retrospectively in the moments before an appointment.
They don’t require face-to-face contact. eCOAs are completed and shared remotely, which has become especially important during the pandemic, when trials shifted to telemedicine and virtual interactions. Giving patients a way to share updates without going to an office keeps them safe and reduces the patient burden, while ensuring trial data continues to flow.

BYOD encourages compliance

Replacing paper with an eCOA also aligns more naturally with the patient’s life, creating a patient-centric data collection experience. To amplify these benefits, many sponsors are embracing a Bring Your Own Device (BYOD) approach to their eCOA practice.

Many sponsors assume they need to provide specialized medical devices to patients in order to complete these assessments in a safe and regulated manner. However, we have found that allowing patients to use their own devices to complete eCOAs increases patient engagement with the process, while meeting all data safety requirements.

When sponsors adopt BYOD, patients can start recording data as soon as they download the app. Because they are rarely away from their phones, the eCOA is woven into their daily lives, giving them the flexibility to complete assessments anywhere. It also makes it harder to ignore reminders and alerts because their personal device is usually by their side.

The eCOA apps are password protected, and the data is uploaded as soon as they submit it, which means even if a patient loses their phone, as soon as they replace it, they can download the app and continue where they left off.

It’s a safe, cost-effective and patient-centric approach that makes trial participation easier for everyone involved.

Life sciences companies are often wary of introducing new technologies to their clinical research workflow, but the payoff of using an eCOA can’t be ignored. Patient-centricity has become a priority for trial leaders, and patients expect their trial experiences to be as seamless as their consumer interactions. eCOAs offer that ease of use, adding value for everyone involved.

Explore how you can be more patient-centric in your next trial by using an eCOA by reaching out to us at ecoa@iqvia.com and connecting with an expert today.

eCOA

Fast, flexible and proven, IQVIA’s industry-leading electronic clinical outcome assessment (eCOA) platform ramps up efficiencies, delivers real-time data, and sharpens insights through best-in-class technology and a better patient experience.

eCOA FAQ

Explore our Frequently Asked Questions (FAQ) page to learn more about general industry eCOA topics and also specific details about our IQVIA eCOA solution.

eCOA Demo Videos

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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