By Melissa Mooney, director, eCOA Solutions Engineering, IQVIA.
Patient centricity has quickly become the biggest buzzword in medicine and clinical research – but it is much more than a trend. Patient centric clinical research allows the healthcare industry to deliver more holistic outcomes for patients, meaning that new treatments not only deliver the desired outcome, but also leave intact or even improve the patient’s quality of life while they are undergoing treatment. As a result of this shift, implementing strategies for capturing the patient’s voice in clinical research has become a top priority for the biopharma industry.
Patients today certainly have more advocacy and are playing a more active role in clinical trial planning and data collection as a condition of their participation, which is a major contributor to this shift. However, regulators and payers are also driving the shift by showing increasing interest in the perspectives of patients as they review submissions for new drug approvals. Electronic clinical outcomes assessments (eCOAs) have emerged as an effective approach to capturing these patient insights that can make or break the trial by giving them a structured platform for reporting their experiences and capturing those reports in measurable and meaningful ways.
What are eCOAs?
An eCOA is a digital approach to capturing patient experience data in traditional clinical trials and real-world studies. During the pandemic, eCOAs shot to prominence in the research space as sponsors sought out more agile tools to capture patient data remotely. At this critical point in time for agile research, eCOAs made it easier for investigators and sponsors to keep track of patient progress outside of the site environment’s confines and collect more patient-specific information to support the safety and efficacy of treatments and their impact on patients’ quality of life.
eCOAs are custom-built interactive assessments that clinical trial participants are prompted to respond to, through provided or personal devices. They allow patients, clinicians, and caregivers to directly report outcomes, supplying real-time insights, and high-quality data collection. These digital assessments have led the way in simplifying patient engagement and amplifying the voice and experience of patience.