In recent years, Electronic Clinical Outcome Assessment (eCOA) has become an increasingly popular form of data collection for clinical trials. It works by electronically capturing patients’ information through various technologies. The purpose of eCOA is to measure physical symptoms, mental conditions, quality of life questions, and the effectiveness of treatments in different settings, situations, and individuals. Essentially, assisTek eCOA technologies are tools designed to understand a patient’s condition and gather the important information needed to help find a cure to better their daily lives.
Is eCOA the best choice for your clinical trials? What are the benefits of doing clinical outcome assessments electronically? How exactly do researchers conduct an eCOA? In this article, we’ll address these questions.
eCOA Clinical Trials: How Do They Work?
Researchers can conduct eCOA clinical trials in several different ways. Data collection varies depending on a patient’s condition and cognitive ability. These are the 5 main ways that eCOA clinical trials collect data:
- Patient-Reported Outcomes (PRO): Patients report their own symptoms, usually through a questionnaire.
- Observer Reported Outcome (ObsRO): A friend, parent, partner, or adult child observes and reports their observations.
- Clinical Reported Outcomes (ClinRO): A healthcare professional observes and reports symptoms.
- Performance Outcomes (PerfO): A healthcare professional asks patients to perform tasks. In turn, they will observe the patient and give information about their condition.
- Electronic Patient-Reported Outcome (ePRO): Using electronic devices such as smartphones and tablets to report symptoms.
Why Use Electronic Clinical Outcome Assessment?
There are many benefits of using electronic clinical outcome assessment for clinical trials. Here are a few of the reasons to choose eCOAs:
- By using edit checks to minimize out-of-range or missing data, eCOAs can improve reliability. How? Because data is collected at home. This means that healthcare professionals can remind patients to complete their assessments easily and effectively without asking them to make an appointment.
- Electronic data collection simplifies the process of organizing data. eCOAs stamp data with the entry date and time, making the information easily accessible in case of an audit.
- eCOAs can save you money in the long run. While they may be more expensive initially, the reliability of this form of data collection saves you from the data clarification and query process that inevitably comes from using paper forms.
- eCOAs save you time by eliminating patients’ need to travel to trial sites. Since they can do the assessment electronically from home, a healthcare professional can see the information immediately afterward. This also speeds up the process at the close of the trial. All information will be ready to be submitted to the relevant approval parties and for submission to regulators much faster than inputting all paper source documents from the life of the trial.
eCOA Clinical Trial: Is eCOA Really More Reliable?
Modern technology has made gathering accurate, organized data easier than ever. It helps to eliminate human error and allows clinical trials to move forward without a hitch. Here are some reasons an eCOA clinical trial is the most reliable clinical assessment form.
No More Inconsistencies
eCOAs use branching sequences that keep patients on task. Unlike in-person paper assessments, eCOAs don’t allow you to skip questions or enter conflicting information. Therefore, forms filled out by patients will be more consistent and sensible.
No More Transcription Errors
Human beings aren’t perfect. Sometimes we make mistakes, even when it’s our job to be precise. Electronic Clinical Outcome Assessments automate the process of transcribing data. Ultimately, researchers will be able to enter data seamlessly with an automated process.
Regulatory Standards Are Met
When eCOA is used, much of the risk is taken out of clinical trials. eCOA meets global regulatory standards and is considered Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA).
AssisTek: What is eCOA in Clinical Trials?
Do you want to learn more about eCOA? Are you looking for an eSource Company that can take you through the process and give you helpful resources? AssisTek is ready to serve! For more than 25 years, we have been assisting clients with all different experience levels to implement eCOAs.
If you’re ready to make the switch to electronic management, fill out this form. We will send you a FREE download of our whitepaper, “The Beginner’s Guide to eCOA in Clinical Research.”
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