Electronic Outcome Assessment in clinical trials
eCOA: Electronic clinical outcome assessment
What is eCOA and what does it mean in clinical research?
Electronic clinical outcome assessment (eCOA) is an electronic method for gathering self-reported health outcome information from patients, caregivers, and healthcare providers. eCOA is an umbrella term that typically encompasses the following outcome-collection instruments:
- Electronic patient-reported outcomes (ePROs): ePROs are the most frequently used type of eCOA in clinical trials. ePRO refers to outcome data reported directly from patients electronically, typically via smartphones, tablets, or web platforms.
- Electronic observer-reported outcomes (eObsRo): eObsRO are outcomes reported electronically by an observer, such as a parent, caregiver, or healthcare provider on behalf of a patient. eObsRo is typically employed in populations where study participants may have difficulty self-reporting their symptoms, behaviors or experiences, e.g. pediatric, behavioral or mental health, or rare disease or genetic disorder studies.
- Electronic clinician reported outcome (eClinRo): eClinRO are outcome data that are reported by clinicians.
- Electronic performance outcomes (ePerfO): ePerfO refers to performance outcomes measured electronically through standardized tasks or assessments that evaluate a patient’s ability to perform specific physical or cognitive activities, e.g. a grip strength test or a gait analysis.
- eDiary: An eDiary is one method to capture eCOA, specifically ePROs, as it elicits patients to report directly about their perception of their symptoms, quality of life, and other related domains.
In modern clinical trials, eCOA is a critical source of treatment efficacy data. Data for diverse clinical trial endpoints can be sourced from eCOA, giving researchers direct insight into changes in patient health status, symptomology, and functioning.
What is the difference between ePRO and eCOA?
eCOA and ePRO differ primarily in their scope of data collection.
ePRO is a subtype of eCOA. ePRO captures self-reported health outcome data directly from patients as opposed to caregivers, healthcare providers, or other observers. eCOA, as a broad term, encompasses other types of outcome data, such as eObsRO and ePerfO, which elicit outcome information from other parties involved in a clinical trial.
In sum, ePROs are always a type of eCOA, but not all eCOA is an ePRO.
eCOA & ePRO vs. Paper
The benefits of eCOA and ePRO in clinical trials
eCOA and ePRO systems are designed to improve patient engagement, streamline data capture, reduce errors, and enhance data accuracy. Modern systems include features like automated email reminders and progress trackers to help patients stay on track with their assessments.
Additionally, ePRO systems can offer personalized questionnaires tailored to a patient’s condition or treatment, boosting compliance and the relevance of the data. Integration with mobile devices and wearables enables continuous monitoring, providing a more complete picture of the patient’s progress.
Characteristics of ePRO and eCOA
Objective & integrated
Patient-reported outcome measures for an objective assessment of a patients’ quality of life, can integrated into clinical workflows
Standardized & validated
Validated generic as well as disease specific questionnaires, available in different languages
Electronic & automated
Electronic recording and automated analysis of outcomes, reduces hospital visits and the administrative burden for clinic staff as well as researchers