By Susan M. Dallabrida, Ph.D., Vice President, eCOA Clinical Science & Consulting, ERT
Use of Technology Increases Patient-Site Communication and Candor
As more and more questions arise about improving patient engagement in clinical trials, many sponsors are finding that the answers may lie in the use of technology. Most pharmaceutical companies are considering methods for implementing novel technologies, e.g., activity trackers and mHealth devices in their trials, in order to maintain better, more consistent interaction with study subjects. Many of these devices are still in proof of concept testing. Whether they will find their place in clinical research will be the global regulators’ decision as consumer devices must satisfy FDA guidelines as a medical device when used to collect endpoint data within a clinical trial.
What many sponsors may not realize is they already have access to regulatory-approved technology that can address current patient engagement challenges. Researchers will find that the use of electronic clinical outcome assessments (eCOA) not only improves data quality, but also offers the potential to improve patient engagement during clinical development.
The benefits of capturing high quality clinical trial data via eCOA have been widely recognized for more than a decade. Researchers have documented significant improvements in patient protocol compliance and data quality, a reduction of missing data and data ‘noise,’ and most importantly, increased study power with fewer patients.(1)
Here we review some of the well-established literature demonstrating how eCOA can also improve patient/clinician communication and candor vs. traditional paper-based COA, helping sponsors to keep patients better engaged during clinical development.
eCOA Increases Patient/Clinician Interactions
eCOA prompts and increases patient/clinician interactions and enables subjects to think through their symptoms prior to meeting with site staff. As a result, patients are more likely to bring up clinical events in discussions with the clinical site, since the eCOA completion prompts their memory of additional details. For example,
eCOA Prompts Increase Patient Candor and Reporting of More (and More Severe) Events
eCOA has been proven to increase patient candor. Patients are more likely to report more severe and more events electronically than on paper. This principle applies across a spectrum of indications and is generally applicable to patient-reported data. Patient reporting on diverse topics such as medication compliance and blood glucose levels are common examples.
eCOA Increases Patient Candor in Suicidal Ideation and Behavior
Self-reported electronic data capture enables increased patient candor in suicidal ideation and behavior. Patients are more likely to reveal a higher frequency and severity of symptoms than ascertained by site interviewers. These phenomena are also well documented for topics including sex, drug/alcohol abuse, obesity, HIV, and mental health.
There is a wealth of evidence demonstrating the value of eCOA in fostering better communication and increasing candor between patients and clinical site staff, as well as in improving clinical outcomes.
By providing regulatory-approved technology that enables better patient: physician communication during a trial, sponsors will reap the benefits of higher quality data collection — and also improve patient engagement during clinical development.
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