How eCOA enables high-quality clinical trial data collection
Several data collection methods are used—whether through provisioned or bring-your-own mobile data collection devices—to gather clinician-reported, patient-reported, and observer-reported outcomes. Some assessments that are collected include diaries, indication specific and quality-of-life questionnaires, and even wearables like Fitbit and activity monitors for performance outcomes.
With eCOA, the clinical trial questionnaire data collection process is improved through:
Better patient reporting
For patients, eCOA brings the convenience of entering data electronically wherever they are, minimizing recall errors and fostering sustained participation in clinical trials. Reminders for data submission help patients enter their data in real-time and can prevent data from being discarded due to inaccuracies. An early and pivotal eCOA study revealed that electronic patient outcomes reporting achieved 94% patient compliance, compared to the 11% compliance observed with paper-based methods. Since then, on average, studies using paper tend to achieve approximately 50% on-time reporting compliance.
Real-time data and insights
Site and sponsor teams get immediate visibility to patient information and data entry, which enables faster decision-making and interventions when necessary. The real-time data entry also eliminates errors associated with transcribing paper-based data into an electronic system.
Data privacy and compliance
eCOA platforms use encrypted channels to transmit patient data to study databases, protecting confidentiality and providing data protection while adhering to regulatory standards. The real-time visibility into outcomes data allows sponsors to respond promptly to data gaps and compliance issues, promoting data accuracy throughout the trial.
Subsequently, the data collected and stored in an eCOA solution can be seamlessly integrated with other eClinical technologies like Interactive Response Technology (IRT) or electronic data capture (EDC) systems—reducing data re-entry. Study teams then have better data integrity and a clean database ready for analysis. The real-time visibility also allows them to proactively monitor trial progress, making sure that the data collected is compliant before submission.
Increasing the chances of clinical trial success with eCOA
Today’s clinical trials require resilience and demand efficiency, speed, and accuracy.
Electronic patient-reported outcomes (ePROs) use is associated with improved clinical outcomes and reduced resource utilization. ePROs have become an indispensable part of clinical trials in which they provide key information about participants' health-related patient-provided information about symptoms, side effects, drug timing and other questions recorded on an electronic device during a clinical trial of life PRO systems can be accessed through computers or mobile devices and may be in the form of electronic.
1. eCOA and ePRO
and Their Use In
Clinical Trials
PRESENTER:
Soumya pottola
soumyapottola19@gmail.com |https://clinicalda.blogspot.com | +1 (972) 891-9506
2. PRO(Patient Reported Outcomes) and
ePRO(electronic Patient Reported
Outcomes)
Electronic patient-reported outcomes (ePRO) in a
clinical trial allow patients to answer questions and
report on their health through an electronic device,
such as a smartphone or tablet.
Using ePRO in a clinical trial starts with trial design.
A study team will decide what feedback they want
from patients, and the best format to capture that
information, whether through an app, e-patient
diary, or other form. Patients may use devices
provided by the trial, or install an app on their own
device.
4. There are different types of ePROs such as:
● Electronic questionnaires that periodically assess patients’ health status at
predetermined times set by the clinical trial protocol on tablets, computers, and
mobile devices
● Patient diaries or activity logs that involve data entry by the patient at any time
convenient to them which can help detect safety issues as soon as they occur
● Fitness and health trackers that automatically record data without any
intervention from the patient
● Ecological momentary assessment (EMA) that assesses a patient’s experiences,
behaviors, and moods as they occur in real-time
Electronic patient-reported outcome (ePRO) measures allow data to be entered directly by patients in an
electronic format. Like other eCOAs, ePROs also have certain distinct advantages over traditional PRO
measures such as:
● Real-time data capture which is particularly important in case of pain symptoms and safety events
that require immediate attention
● Better patient adherence because of easy-to-fill questionnaires that allow for data entry at the
time of occurrence
● Improved patient convenience as data can be collected from technologies such as smartwatches
and is transmitted directly to research teams without any change in the patient’s daily activities
5. COA(Clinical outcome assessments)and
eCOA(electronic Clinical outcome
assessments)
The United States Food and Drug
Administration (FDA) defines a clinical
outcome assessment (COA) as a
measure that describes or reflects how a
patient feels, functions, or survives.
There are various types of COAs
depending upon the person reporting
the patients’ symptoms, but the
fundamental focus is on patient health
status
7. The various types of COAs are as follows:
● Patient-reported outcome (PRO) measure:
measurement based on a report comes directly from the patient/study subject about the status of the patient’s health condition
without any amendment or interpretation by a clinician or anyone else.
● Observer-reported outcome (ObsRO) measure:
measurement based on a report of observable signs, events, or behaviors related to a patient’s health condition by someone
other than the patient or health professional such as a parent, caregiver, or someone who observes the patient in daily life.
● Clinician-reported outcome (ClinRO) measure:
measurement based on a report that comes from a trained healthcare professional after observation of a patient’s health
condition through interpretation of observable signs, behaviors or other manifestations related to the disease or condition.
