There has been significant research documenting the benefits of using electronic clinical outcome assessments (eCOA) in clinical trials. The first blog in this series gives an overview of how eCOA improves data quality, as compared to traditional paper-based COA methods.
But, you may not be aware that eCOA delivers many other benefits as a result of its ability to capture data in real-time. For example, flagging any adverse effects patients might be experiencing.
Read on or watch this short video to learn more about the benefits of electronic data collection.
Real-time Insights into Patient Safety
With (eCOA), access to real-time data enables early detection of potential patient safety concerns, including symptom worsening, extreme patient dosages and adverse effects. Study administrators can pre-configure key risk indicators (KRIs) and set data thresholds that enable them to proactively mitigate risks throughout a trial.
If a patient assessment is flagged for a potential KRI, the eCOA system automatically triggers a notification and immediately alerts designated users at the site via automated emails. Site personnel can then take appropriate corrective action and intervene, per the trial protocol.
With paper-based COA, however, you’ll find yourself looking in the rear-view mirror at retrospective data, which leaves your trial open to risks and vulnerable to more substantial issues.
Real-time Insights into Study Performance
Unlike paper methods, electronic data capture allows you to leverage real-time data to better manage and predict trial performance. You can view early and interim study results and gain actionable intelligence across studies, sites and patients, then use these real-time insights to plan improvements or remedial actions, assign tasks to project team members, and track status to ensure appropriate steps are being taken. For example, interim analysis reports can identify underperforming sites to help you get them back on track or to monitor compliance and encourage patient participation where necessary.
More Efficient and Shorter Studies
The higher-quality and real-time nature of electronic data collection leads to operational efficiencies and, ultimately, shorter study timelines. For example, if you rely on paper-based COA data collection, before closing out a study, you must wait for manual data transcription, quality checks and verification that not only require additional resources but tend to be more error-prone.
eCOA eliminates the need for data transcription, significantly reduces the amount of quality checks / verification throughout a study and decreases the time from last patient, last visit (LPLV) to final data transfer, getting you to study close-out sooner. And, you’ll have access to documentation that meets regulatory requirements.
Investigative sites also benefit from the reduced burden that eCOA delivers. Simple log-in procedures, easy patient set-up and streamlined visit management are just a few of the workflow efficiencies that eCOA offers. And as an added bonus, real-time data collection, centralized data management and wireless information exchange with integrated medical devices and wearables dramatically reduces site workload and the volume of queries generated throughout a trial.
Continued reliance on outdated, error-prone paper diaries may introduce unnecessary risk into your clinical trials. Avoid these risks and benefit from significant improvements in data quality, patient safety and site performance by implementing eCOA in your next study.
Learn more about the benefits of eCOA in ‘7 Reasons to Implement Electronic Data Collection in Your Next Clinical Trial.’ And, check back soon for our last installment to this series, which reviews how eCOA keeps patients more engaged and compliant throughout clinical studies.
Dee Zepf is a Senior Director of eCOA Product Management at ERT.