Improving patient and trial outcomes using eCOA to connect trial data

Author: Andrés Escallón, VP eCOA Practice

Snapshot: 

• Stigma Slows eCOA Adoption: Sponsor concerns around complexity, cost, and implementation issues impede eCOA adoption and more accurate reporting. 

• eCOA to Track Diverse Data: eCOA can help collect different data types, providing sponsors comprehensive report of patient outcomes throughout trials. 

• Value in Vendor Collaboration: Simplified eCOA design and streamlined technology allows sponsors and sites to focus on critical science and patient care. 

Electronic Clinical Outcome Assessments (eCOA) have become an established tool in modern clinical trials, offering a digitized method to capture outcomes data critical for the evaluation of new treatments and therapies.  

Despite its widespread adoption, eCOA still carries a stigma among sponsors and CROs–that it is complex, expensive, and always on the critical path of clinical studies. Part of the stigma stems from many vendors’ limited expertise in data science, technology implementation, licensing, and localization. Limited regulatory guidance on eCOA applications also creates challenges, as sponsors, CROs, and vendors have to cut through confusion for valid implementations.  

These concerns about eCOA, although not entirely unfounded, are potentially holding the pharmaceutical and clinical trial sectors back from efficiently capturing high quality data and using that data to bring new medicines to patients in need.  

Drawing on examples from dermatology, this blog explores how eCOA can improve data collection, and even more importantly, can be a tool to connect various types of data in clinical trials to improve patient and trial outcomes.  

The promise of eCOA: connecting diverse data types across a clinical trial 

Dermatology clinical trials collect many types of data to assess the effectiveness of new therapies. For example, data on patient symptoms and experiences are often collected through patient questionnaires, like the Itch-Numerical Rating Scale (Itch-NRS) and the Dermatology Life Quality Index (DLQI). In addition to these Patient Reported Outcomes (PROs), clinicians generate their own data about the extent of the patient symptoms on scales such as the Eczema Area and Severity Index (EASI), and digital photographic images of patients' skin are both accessible and particularly helpful for evaluating treatment effectiveness. 

Taken individually, each data collection method has challenges. Patient questionnaires, usually subjective in nature, may lead to variability across an entire set of trial participants. At the same time, dermatological symptoms can fluctuate significantly over a period of days, making it challenging to capture consistent and accurate data if questionnaires are only collected at visits that are separated by weeks. Clinicians observe patients’ conditions but do not experience those symptoms themselves, and images provide objective documentation without the subjective experience of patients. 

Well-implemented eCOA solutions can help sites and sponsors mitigate these data accuracy challenges, by allowing for frequent, real-time data collection through digital devices and standardizing the data collection process across study sites. More importantly, eCOA can also be a tool to connect these various types of data to create a more complete picture of patient outcomes in response to novel treatments. 

Using eCOA to strengthen analysis across multiple data types 

eCOA systems can also play a role in connecting data reported by patients or clinicians, passive data collection from wearable devices, and benchmark data. 

For example, while wearables offer continuous, objective data, they don't tell the whole story. Understanding both the physical activity data and its impact on patients' quality of life is crucial. This is why questionnaires remain essential in clinical trials today. 

The opportunity for eCOA solutions lies in their potential to combine these data types, providing context and deeper insights. For instance, anecdotal evidence around pain studies suggests that wearables and patient-completed diaries may show different results, but when combined tell a consistent story. In pain studies, data from wearables may show an increase in sedentary behavior. In diaries, participants who move less often report less pain—that is, they can sit still and relax. By combining these two types of data, clinicians and study sponsors seem to be able to more comprehensively understand patient outcomes. 

eCOA systems can help connect these data points, using standard measures like the Patient Global Impression of Change (PGIC) as benchmarks. Collecting benchmark assessments like the PGIC allows researchers to interpret the significance of changes in various measures, whether from questionnaires or wearable devices, in the context of the patient's overall experience. eCOA can connect other questionnaires and data points to determine the significance of change, helping clinicians and sponsors to understand how important a particular change is based on the patient's overall condition. 

By facilitating this connection between diverse data types, eCOA can provide a more comprehensive view of patient outcomes, enabling more nuanced and accurate analysis in clinical trials. 

Vendor collaboration for smoother clinical trials 

As a clinical trial technology vendor, Suvoda aims to streamline trials for sponsors and CROs. Most eCOA solutions suffer from significant over-design, and this has been a big factor adding to the stigma that eCOA is hard and the data analysis is complex. However, by simplifying eCOA design and focusing on collecting only the data that truly matters to measure study endpoints, we have an opportunity to combine traditional eCOA questionnaires and new data collection methods in ways that simplify. That just work.  

Doing all of that requires collaboration to create cohesive solutions. Our goal as technology vendors should be to create an integrated technology environment that functions smoothly, allowing sponsors to focus on their critical scientific work and patient care. By working together to create more compatible and complementary technologies, we can help create a more seamless experience for sponsors, CROs, and sites. 

Ultimately, when eCOA fulfills its potential to collect and connect data, and when vendors effectively collaborate, researchers can stay focused on conducting high-quality clinical research to bring essential medicines to patients faster. 

ON-DEMAND WEBINAR

Author

Andrés Escallón
VP eCOA Practice
Suvoda

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