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How eCOA Improves Patient Experience

The Importance of a Good Patient Experience

It is critical to ensure clinical trials are truly patient-centered. Although the intention to incorporate patient input and feedback can be seen throughout the clinical research industry, clinical research studies often don’t rise to that challenge. In order for clinical trials to be designed in a way that is truly patient-centric, sponsors and contract research organizations (CROs) must acknowledge that every patient comes in with differing needs, expectations and backgrounds. Although it may not be possible for today’s clinical research studies to efficiently and effectively address each patient individually, there’s opportunity to better incorporate patient voice throughout a trial. Sponsors and CROs should take the first step to identify individual needs and find a common thread that can align an entire patient group. Messaging, recruitment, study design and protocol mandates can all be adjusted with the patient voice in mind.

What is eCOA?

eCOA is defined as a method for the electronic capture of clinical outcome assessment data from the source (the participant, a caregiver, a clinician, etc.), utilizing technologies including smartphones, tablets and web-based applications. It replaces traditional paper-based recording in order to increase study efficiency, decrease risk of user error, reduce site monitoring burden and reduce costs by providing the flexibility to collect data digitally in the clinic or remotely.

How eCOA Can Help

eCOA may encompass patient-reported outcome assessments (PRO), clinician reported outcome assessments (ClinRO), observer reported outcome assessments (ObsRO) and performance outcome assessments (PerfO). All of these assessments employ technology to allow users to enter and submit health outcome data remotely.

eCOA can be conducted in a variety of ways while maintaining the “fit-for-purpose” validation requirements set by regulators (1). For example, the eCOA data collection can be done within the participants own environment on a handheld device. Such services are device agnostic, do not require provisioned devices, and allow the users (participants, caregivers, home health nurses, etc.) to be anywhere while conducting assessments. Where required, eCOA collection can also be facilitated by using virtual tele-health visits in place of on site visits. This adds flexibility to the process while meeting all eCOA license holder requirements around content, interface specifications, form factor restrictions, and process steps. eCOA, combined with specialized tele-health platforms can digitally recreate much of the in-person visit experience (1). Using the video and audio recording capabilities of a user handheld device, for example, assessments of participant movement and vocal characteristics can be made remotely, which then can be assessed and reviewed by the study team.

An advantage of study specific participant applications, which can be accessed on a handheld device, is the ability to house a wealth of easily accessible support content. Participants can access content like videos, diagrams, or text on a variety of topics, such as device and application training, answers to frequently asked questions, education on their condition and symptoms, and when to and how to schedule a tele-health visit. Handheld devices, such as smartphones and tablets, are particularly useful at providing bite-sized content. This utility is a perfect fit for providing clinical trial participants and other users of eCOA applications, with easily accessible resources to support them over the course of a study. This helps them to address potential issues before they become problems and can help reduce the need for clinical team outreach, saving time and cost.

eCOA is a flexible solution that allows for the remote collection of patient, clinician, and observer reported outcome data. The use of eCOA, therefore, should be standard for most of today’s decentralized studies, including hybrid studies that blend site-based study approaches with remote data collection and submission capabilities that do not require site visits.

Our eCOA report covers this topic extensively. For more information about eCOA, click here to read the full report.


(1) Perspectives and Guidance for Effective eCOA in Global DCTs

Chris Watson

Director, Consulting at THREAD

Chris is an experienced Product leader and clinical system specialist with over 21 years’ experience of product management. Combining practical experience of roles within clinical development with a keen interest in leveraging technology, a thought leader in eCOA solutions and patient-facing technologies, Chris is helping shape the direction and application of global eClinical solutions