eCOA+
From bottlenecks to breakthroughs: How AI is transforming translation timelines
According to ClinicalTrials.gov, there are 3,046 multi-country trials being conducted this year. While many trials remain localized within a single country, there has been a definitive movement towards conducting trials in multiple countries, especially for larger, later-stage trials. This is driven by the positives that multi-country trials offer, like faster patient recruitment, lower costs in some regions, and the need for diverse patient populations.. However, behind the scenes, a critical bottleneck has been slowing many trials down. This bottleneck is the translation process that’s required to make trials work across multiple languages, locales, and regulatory bodies/organizations.
What is eCOA? An overview of eCOA in Clinical Trials
What is eCOA?
As FDA Principal Deputy Commissioner Janet Woodcock said in a 2015 Clinical Outcome Assessment Public Workshop, “It turns out that what is really bothering the patient and what is really bothering the doctor can be radically different things...patients are true experts in their disease.”
Clinical outcome assessments (COAs) have been key to capturing a comprehensive picture of patient experiences and treatment outcomes in today’s research landscape for decades. Integrating COAs into trial protocols bolsters our treatments' scientific integrity and enhances our ability to understand the real impact of interventions on patients.
COAs (called eCOAs when captured electronically) are essential to understanding whether a drug reduces symptoms, improves patients’ quality of life, and improves their ability to perform activities they care about.
Since the mid-2010s, electronic clinical solutions, like eCOA, have rapidly replaced their paper counterparts. Electronic Clinical Outcome Assessments comprise systematized digital methods for capturing patient-centered outcomes in clinical trials. These systems utilize validated electronic interfaces to collect, store, and analyze patient-reported data, clinician observations, and performance metrics.
Why cloud-based eCOA software is becoming the industry standard
The landscape of clinical trials is evolving rapidly, and at the forefront of this transformation is eCOA (electronic Clinical Outcome Assessment) software. This technology is streamlining data collection, enhancing patient compliance, and ensuring regulatory adherence like never before.