eCOA in Clinical Trials: Enhancing Data Quality & Outcome

What is eCOA?

eCOA stands for electronic capture of clinical outcome assessments, COAs. COAs are measures of how a patient feels, functions or survives. There are four types of COA that we see in clinical trials:

• Patient-reported outcome (PRO). This is a report of the status of a patient's health condition that is made directly by the patient, without interpretation by a clinician or anyone else. An example might include asking a patient to record their symptoms severity on a daily basis, or responding to questions evaluating their quality of life.
• Clinician-reported outcome (ClinRO). This is a report that comes directly from a trained healthcare professional after observation of a patient’s condition. An example might be a psychiatric interview of a patient to score the severity of depression using a validated measure such as the Hamilton Depression Rating Scale.
• Observer-reported outcome (ObsRO). This is measurement based on an observation by someone other than the patient or a healthcare professional, such as a parent or spouse. An example might be assessing the restlessness and irritability of a child suffering from a condition causing pain.
• Performance Outcome (PerfO). This is a measurement based on a standardized task completed by the patient. An example might be the distance a patient is able to walk in a six-minute time interval following a corridor circuit at the investigational site (six-minute walk test, 6MWT).

Collecting COA data electronically, using eCOA, drives high data quality, and enables effective patient oversight between clinic visits.

Are eCOA primary endpoints?

Clinical outcome assessments (COAs) are used to derive important clinical endpoints in clinical trials and to support regulatory new drug applications (NDAs). In some disease areas, COAs are primary study endpoints. For example, clinician ratings (ClinROs) often represent the primary endpoints in many psychiatry and neurology disease trials, including depression, anxiety, schizophrenia and Alzheimer’s disease. In other diseases, patient-reported outcomes (PROs) may be primary endpoints. Examples include migraine, epilepsy, hemophilia and chronic pain.

COA data are often also represented as important secondary endpoints in many clinical trials, including oncology studies.

Is eCOA data used in labeling claims?

Information from COA data are an increasingly important element of treatment decision making by patients with their doctors. A growing number of drugs across a wide range of disease areas include patient-reported outcomes (PROs) and other COA data on the medication labelling, and this includes data captured using ePRO and eCOA solutions.

Is eCOA used in pricing and reimbursement decision making?

COAs are an essential component of health economic evaluations required by many health technology assessment (HTA) organizations, including quality-adjusted life years (QALYs), and health economic models.

What is ePRO?

ePRO is the electronic capture of patient-reported outcomes, usually using a smartphone app or via the web. ePRO solutions enable high quality data to be captured from patients both at home and at site during clinic visits. ePRO apps also contain important features to drive on-time completion, including alarms and in-app notifications to remind patients when assessments are due.

eCOA high quality data

ePRO and eCOA solutions drive high data integrity and high data quality, especially compared to using pen and paper.

ePRO solutions improve data quality compared to paper data collection in a number of ways, including:

• In-built logic and error checks to eliminate ambiguous or invalid data
• Time and date stamped entries to measure data integrity
• Completion windows to drive timely entries and accurate recall
• Completion reminders to limit missing assessments