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Explanations about eCOA & ePRO in clinical trials

An Electronic Case Report (eCOA) and an Electronic Protocol Registration and Results System (ePRO, ePARR) are two software tools intended to facilitate the communication of clinical trial data. This educational material aims to explain epro and ecoa, why they have been created, and how they work.

eCOA and ePRO, what do they do?

eCOA (electronic Clinical Outcome Assessment) and ePRO (electronic Patient Reported Outcome) are becoming increasingly important in the clinical trial industry. They are critical components of an overall trend towards electronic data capture in clinical trials.

eCOA is a system that allows patients to report their symptoms, treatment satisfaction, quality of life, and other patient-reported outcomes by capturing and storing the data directly from patients.

Patients have been reporting their outcomes on paper for many years. The problem with paper-based reporting is that it can often involve manual transcription, resulting in errors and inconsistencies. As a result, paper-based reporting is not usually included in the final database for results analysis; and therefore, the data is not considered important enough to be included in official reports.

As a result of this inaccuracy, researchers have sought out more accurate methods of collecting patient-reported outcome data. This has led to the development of eCOA (electronic Clinical Outcome Assessment). This new technology allows researchers to accurately capture and store data directly from patients without manual transcription or “middle man” involvement.

Who uses them and why?

eCOA and ePRO are digital assessments that patients can use to measure their symptoms, such as pain, fatigue, and anxiety. They can be recorded through various devices, including tablets, smartphones, or computers.

While these systems have been around for decades, they were initially difficult to use and were only used in large clinical trials. Researchers have recently started working toward making them more intuitive; a new generation of eCOA and ePRO has emerged that allows patients to record their symptoms in more detail than ever before. The results of this work are already being seen in the growing use of eCOA and ePRO—they now account for close to 10% of all patient-reported outcomes (PRO) studies.

Many research teams are turning toward eCOA and ePRO because they offer a wide range of benefits over paper-based assessments:

  • Easy to use
  • Convenient for both patients and healthcare professionals
  • More accurate data collection
  • Real-time reporting

By using these types of assessments instead of traditional surveys or diaries, researchers can better understand what’s going on with their patients and help them feel more comfortable reporting their symptoms.

Are data collected via eCOA or ePRO different from those contained traditionally?

Data collected via eCOA or ePRO are not different from those gathered traditionally. All data are derived from patients’ responses to the questionnaire. Some of the advantages of using eCOA and ePRO include:

  1. Ease of use for patients: Today, many people have become more comfortable using tablets and smartphones and prefer to use them instead of traditional paper questionnaires.
  2. Less time-consuming for patients: Compared to conventional paper questionnaires, it is much easier and faster to complete an electronic questionnaire.
  3. More convenient for patients: Electronic questionnaires can be completed anywhere, anytime, as long as there is internet access available. Patients may also be able to meet these questionnaires even if they are not physically present at their doctor’s office.
  4. Better accuracy and quality of data: It is much easier to ensure that the data is accurate when entered into a system by a computer rather than manually by a human being or by handwriting.
  5. Higher data accuracy: Since the data are directly entered into a system, there is no need for someone else (e.g., research staff) to read it and enter it into another procedure later on, which may increase the risk of errors.

How are the data collected via eCOA or ePRO managed?

Data from electronic Clinical Outcome Assessments (eCOA) or electronic Patient Reported Outcomes (ePRO) are managed similarly to the data collected via paper and pencil. The records are transferred to the clinical site and then entered into an electronic data capture system. However, there are a few differences between eCOA and ePRO data management compared to traditional methods:

  • The data is often entered directly into the eCOA or ePRO system rather than being transcribed by hand.
  • The information is transmitted securely through the web.
  • A digital trail allows users access to previous versions of completed forms.
  • Data may be approved by a monitor in real-time, making issues visible quickly to be addressed immediately.

Is eCOA or ePRO for me?

eCOA is a fantastic option for clinical trials measuring patient-reported outcomes, such as pain or quality of life. It’s also a great way to measure patient compliance and adverse events. ePRO is ideal for clinical trials measuring more objective data points, like blood pressure or cholesterol levels. Furthermore, if your study population is at high risk of missing visits and being non-compliant overall, ePRO is the better choice.

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