What Is eCOA? Improving Clinical Trial Data Quality

The Language of eCOAs

Capturing how a patient functions, feels, and survives is a key part of understanding the benefits that a treatment has to offer during the development of new therapies. This type of information is captured with clinical outcome assessments, known as COAs.

Read on to learn more about COAs, and their electronic counterparts, eCOAs.

The four types of COAs

• Patient-reported outcomes (PRO)

• Based on a report that comes directly from the patient about the status of their health condition, without interpretation from a clinician or anyone else.
• Symptoms or other concepts that are not observable and known only to the patient (for example, pain severity or headache intensity) can only be measured with PROs.

• Clinician reported outcomes (ClinRO)

• Based on a report that comes from a trained healthcare professional after observation of a patient’s health condition.

• Observer reported outcomes (ObsRO)

• Based on the report of observable signs, events, or behaviors related to a patient’s health condition by someone other than the patient or a healthcare professional.
• ObsROs are most commonly reported by a parent or caregiver (who is not a healthcare professional), or someone who observes the patient in their daily life.
• Importantly, they do not include medical judgement or interpretation.  

• Performance outcomes (PerfO)

• Based on standardized tasks performed by patients that can be administered and evaluated by an appropriately trained individual or completed independently (for example, word recall or timed walking tests).

Benefits of eCOAs to clinical trials

Within the clinical trials industry, COAs have been traditionally completed with paper and pencil. However, capturing COAs on an electronic device, such as a smartphone, tablet, laptop, or desktop computer, is now commonplace. Known as eCOAs, these can be collected both onsite or remotely, and include ePROs, eClinRos, eObsROs, and ePerfOs.

The use of eCOAs provides many benefits to clinical trials, including improved data integrity and quality, reduced site and CRO burden, as well as the inclusion of a more diverse population of participants on account of the increased flexibility and reduced travel burden. Plus, they are an integral part of decentralized clinical trials (DCT), which don’t have a centralized location and instead meet patients where they are through telehealth or other remote solutions, allowing researchers to greatly expand who they can reach.

You can read more about how eCOAs benefit clinical trials and patients here.

If you are ready to get started with eCOAs, contact Medable today, your expert eCOA clinical trial partner.