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eCOA

The Benefits of Using eCOA in Clinical Trials

Dallas Miles

Clinical Outcome Assessments (COA) are a standard part of any clinical trial. Electronic clinical outcome assessments (eCOA) are not new. Still, despite being recommended by regulatory authorities like the U.S. Food & Drug Administration (FDA), many study teams still choose to collect assessment data the old-fashioned way, with pen and paper. With trials becoming more advanced and the industry acknowledging the need to reach more diverse and widely dispersed populations of patients, paper COAs add unnecessary risk.

Why Not Paper?

While there are some types of COA, such as specific behavioral assessments, that still must be done by paper, switching to eCOA is appropriate in most cases because:

  • Paper can easily get lost, damaged, or destroyed
  • There is no way to verify when a paper assessment is filled out – did the patient fill it out when they were supposed to, or did they hastily jot things down in the parking lot before entering the clinic?
  • It is more challenging to control bias with paper assessments; for example, assessors may have the ability to view previous responses for comparison, which may impact how they record data
  • Data recorded on paper still needs to be entered, at some point, into a digital format, taking time and opening the door for human transcription errors

eCOA Helps Improve Patient Experiences

Making clinical trials more accessible to broader and more inclusive populations of patients means looking beyond trial site geography. Travel burdens associated with clinical trial visits remain among the most common obstacles to potential study participants. Frequent travel, long-distance travel, and even extended relocation make it difficult to impossible for many patients. Pressure remains to reach more patients, particularly in communities and cultures traditionally underrepresented in clinical research. Using eCOA, study teams can allow patients to participate at least remotely, reducing the need for some in-clinic visits. Patients via ePRO (electronic patient-reported outcome assessments) or caregivers via ObsRO (observer-reported outcome assessments) can utilize intuitive technologies to fill out assessments quickly and confidently with minimal disruption to their lives.

eCOA Helps Make Trials More Efficient

Whereas paper COAs can leave a lot of opportunity for error, eCOA strategies can be closely aligned with the study protocol and the needs of the patients to collect data with a high degree of accuracy and reliability. eCOA data can be immediately uploaded into the study management platform, giving study teams near real-time visibility into patient status. No time is lost waiting for paper COAs to be delivered to the study team, which can sometimes occur days after the event. Nor does the study team need to use valuable time manually entering paper COA data into a digital system. This allows patient issues to be identified quickly so that study team members can intervene. Whether a patient has recorded an adverse event, has come down with a secondary illness, or is struggling in some other way, eCOA helps get that information to study teams much more quickly than paper COA.

eCOA Can Help Contain Costs

One of the most common reasons researchers choose to stick with paper COA is the perception that it is cheaper than eCOA. Yet, there are hidden costs to paper COA that eCOA avoids, such as:

  • Labor in collecting, compiling, and storing paper COAs
  • Labor in entering COA data into the study management platform
  • Time and labor associated with correcting errors or following necessary procedures for record loss, such as the completion of deviation forms
  • Time and labor associated with data verification and ensuring regulatory compliance

eCOA, on the other hand, collects the data directly from the source and enters it immediately into the study management platform. This saves time and allows study team members to be more efficient and focus on other essential tasks.

The demands of modern clinical trials are too great to risk relying on traditional approaches to data collection. Applying patient-centered eCOA strategies can help to enhance patient engagement and improve trial efficiency, leading to higher quality data, all while providing a more predictable and containable cost structure versus paper.

For more information about getting started with a patient-centered eCOA strategy, visit THREADResearch.com.