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eCOA and ePRO
and Their Use In
Clinical Trials
PRESENTER:
Soumya pottola
soumyapottola19@gmail.com |https://clinicalda.blogspot.com | +1 (972) 891-9506
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.
Various measures by Pro
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
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
Types of Clinical Outcome Assessment (COA)
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.
Difference between ePRO and eCOA

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eCOA and ePRO and their use in Clinical trials

  • 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
  • 6. Types of Clinical Outcome Assessment (COA)
  • 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.