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Three Ways that eCOA Improves Data Quality

Dallas Miles

In recent years, many in the research industry have transitioned from manual, paper-based clinical outcome assessment (COA) strategies to the digital alternative (eCOA), discovering the benefits and advantages – both for patients and study teams – of eCOA over paper. A key advantage of eCOA is the facilitation of more accurate and reliable data collection, leading to better quality study data overall. Despite this, some researchers continue to rely on labor-intensive manual methods for collecting COA data.

The following is a quick guide to the key ways that eCOA works to help all study stakeholders (patients, caregivers, study teams, etc.) produce better data:

#1. eCOA Brings the Study to the Patient

Clinical trial participation can be difficult for patients in several ways. Perhaps the biggest challenge is the travel demands on participants and their families related to getting to and from clinical trial sites. This is particularly true for patients with mobility issues or those with suppressed immune systems who want (or need) to avoid any situations that put them at risk for catching other illnesses, as we saw with COVID-19. eCOA can help reduce the need for some clinic visits while making necessary visits less intense for patients by eliminating the need for lengthy assessment interviews.

Clinical teams can also engage patients via eCOA – often as part of a Telehealth visit – to collect data between visits, which can lead to critical participant insights. Easy-to-use eCOA apps allow many participants, or their caregivers, to submit data remotely from a device of their choice (computer, smartphone, tablet, etc.) or a device provisioned by the study team. Apps that feature reminders and alerts, along with simple data submission guides, help patients to submit data accurately and as frequently as needed according to the study protocol. For patients who may require more assistance, eCOA can be utilized alongside Telehealth visits with clinicians or during home nursing visits. The flexibility afforded by eCOA helps patients to remain safe and comfortable in their homes more often while providing study teams with reliable, accurate, and near real-time outcomes data.

#2. eCOA is More Easily Tailored and Scaled for Specific Patient Groups

To make studies work better, we must all do a better job of listening to patients. Collecting their perceptions and insights can help researchers build studies that address their needs, setting patients up to be successful clinical trial participants. Patient-centric eCOA strategies help to achieve this by using insights gathered from patients through a combination of traditional qualitative methods like interviews and innovative, data-driven technologies that reveal the full scope of support needed by a given population of patients. Outcome assessments are then crafted that address the unique circumstances of these patients, considering their challenges – both medical and lifestyle-related. These assessments, then, can be scaled globally via eCOA strategies that meet the cultural and language requirements of all patients while maintaining compliance with all countries represented in the trial.

Attempting to manage necessary data transcriptions from paper to the source database can be difficult and labor-intense, adding to costs and slowing the study down. As an increasing number of clinical trials go global in order to build more inclusive and representative studies and make studies more accessible for broader groups of patients, eCOA is better suited than paper-based COA strategies for navigating the complexities of global studies, allowing study teams to quickly deploy assessment programs spanning multiple languages and cultures.

#3. eCOA Facilitates Reliable and Accurate Data Sharing

It is no secret that manual data recording processes are subject to human error. In the world of COA, the quality of paper data collection varies widely. We’ve all heard patients filling out diaries in the parking lot before walking into the hospital for a study visit. For paper patient-reported outcome assessments (PRO) and observer/caregiver assessments (ObsRO), the accuracy and thoroughness of the data can always be in question. Even paper-based clinician assessments (ClinRO) pose opportunities for errors, whether in transcription, misunderstandings during interviews, or cases where paper records are lost.

With eCOA, patient-centered assessments walk the user through the process, allowing them to quickly and easily submit data. Easy-to-understand prompts help the patient, caregiver, or clinician to submit all data accurately. This data is immediately uploaded to the study team for review and stored securely, eliminating any chance of transcription errors or data loss.

Why eCOA Makes Sense for All Clinical Trials

Moving to eCOA is not only more patient-centric, but regulators like the FDA are also recommending eCOA over traditional, paper-based methods because of the clear benefits in terms of data accuracy. Further, eCOA can help make study experiences better and less burdensome for many patients, which is critical if we wish to reach broader, more diverse populations. Add the fact that eCOA allows us to build and quickly scale more patient-centered outcome strategies leading to more engaged patients and, ultimately, better data, there is little reason for continuing to cling to tedious, time-consuming, and risky paper processes,

For more information about Patient-Centered eCOA, visit THREAD.