Blog
So You Want Your Trial to be More Patient-Centric? Here's Why an eCOA is Best for That
How to use an eCOA to increase patient-centricity and data collection within your next trial
Melissa Mooney, Director, eCOA Solutions Engineering, IQVIA eCOA
Sep 27, 2024

Anyone familiar with clinical research understands that paper-based patient assessments are a crucial yet challenging aspect of data gathering and analysis for both participants and sponsors.

Collecting patient-reported outcomes (PROs) through these assessments or diaries is essential for capturing the patient’s perspective. PROs also provide sponsors with invaluable insights into patient behavior, adverse events, and other essential clinical trial information. However, traditional paper-based methods for collecting this data are inefficient and fraught with issues.

In trials that utilize paper assessments, patients are instructed to fill them out at significant moments during their treatment. This might involve daily reflections on their well-being or noting down specific quantitative or qualitative data at times that matter during their day.

Patients are supposed to complete the assessments clearly and according to a set schedule. Yet, adherence to these guidelines is not guaranteed. Often, they might complete the forms all at once, perhaps just before their next trial visit, or they might fail to complete them at all. Such practices can lead to gaps in the clinical trial database, impede the timely access to data for sponsors, and compromise the reliability of this inherently subjective information.

Electronic Clinical Outcomes Assessment (eCOA) solutions can address many of these issues effectively

eCOA solutions convert PROs into a digital format that gathers real-time feedback from patients about their condition, trial experience and the treatment's effect on their life quality. This offers numerous immediate advantages.

  1. Data is captured electronically, removing the need to manually transcribe notes into a digital format, which saves time and avoids the difficulty of interpreting handwritten entries.
  2. Data is collected more promptly. In some eCOA solutions, patients can fill in their diaries either online or offline, and upon submission, the information is instantly uploaded to the trial database. This provides sponsors with almost immediate insights into the patient experience, expediting data access and potentially enhancing patient safety and hastening outcomes.
  3. It promotes accountability. Some eCOA systems send reminders and alerts to encourage timely completion of surveys and inform site staff if patients consistently fail to comply. This fosters a responsible culture where patients record data as it occurs, rather than at the last minute.
  4. They eliminate the need for in-person interactions. eCOAs can be completed and submitted remotely, which has been crucial as trials moved to telehealth and virtual engagements. This method keeps patients safe, lessens their burden, and maintains a steady flow of trial data.
BYOD (Bring Your Own Device) encourages compliance.

Transitioning to an eCOA solution is more in tune with patients' lifestyles, offering a more patient-focused data collection experience. To further improve this, many sponsors are adopting a BYOD eCOA strategy.

Contrary to some beliefs, sponsors do not always need to supply specialized devices for assessments. Allowing patients to use their own devices for eCOAs can boost engagement and still adhere to data security standards.

With BYOD, patients can begin logging data immediately after downloading the app. Since people are seldom without their phones, the eCOA becomes integrated into their daily routine, providing the flexibility to complete assessments anywhere. It also makes it more difficult to overlook reminders since their personal device is typically close at hand.

The eCOA applications are secure with password protection, and data is uploaded immediately after submission. Therefore, even if a patient misplaces their phone, they can resume data entry on a new device by simply reinstalling the app.

This approach is secure, cost-effective, and centered around the patient, simplifying trial participation for all parties.

Life science companies may hesitate to integrate new technologies into their clinical research processes, but the advantages of eCOAs are undeniable. Prioritizing patient-centricity is key for trial leaders, and patients now expect their trial experiences to be as streamlined as their everyday digital interactions. eCOAs deliver this convenience, benefiting all stakeholders.

To learn more about enhancing patient-centricity in your upcoming trial with an eCOA, contact us at ecoa@iqvia.com and speak with a specialist today.

 

Related solutions

Contact Us