Electronic Health Reporter

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.

Amplifying the patient voice

Through eCOA implementation, there is an opportunity to significantly improve how clinicians, patients, and caregivers record insights about the patient’s condition, their trial experience, and the treatment’s impact on their quality of life. Researchers can gather valuable insights to help sponsors increase trial efficiencies, reduce study start up timelines, and improve data quality and compliance, ultimately leading to a better trial for both the sponsor and the patient. These benefits include:

• Device accessibility
  • Dedicated provisioned study devices are not necessary for patients to complete assessments. Patients can use their own devices to complete assessments, which increases patient compliance with the completion of patient reported outcomes (PROs). Patients’ daily lives and physical conditions vary and are affected by their disease. This means some diseases may hinder patients’ mobility, sight, or other functions, making tool accessibility for all critical. By offering bring your own device (BYOD) options, this allows patients to engage in the trial using their own devices.
• Tailored solutions
  • Every patient population is different, so leveraging eCOA solutions ensures that the clinical outcome assessment (COA) strategy is fit for purpose and aligns with the targeted patient population. Using COAs helps adjust to specific needs for patients based on study objectives/endpoints such as appropriate usability features to accommodate challenges that may hinder a patient’s ability to complete assessments and consideration for logistics, demographics, and socio-economic status. Collectively these considerations ensure the best success in capturing accurate patient perspectives.
• Accelerated patient experience
  • The seamless data collection that eCOAs enable creates an enhanced patient experience. This reduces the burden of trial participation and promotes better patient outcomes that integrate into existing daily routines to drive compliance. Examples of this can include a more intuitive user interface or the ability to log patient information online or offline.

Building a better future

Looking forward, patient centricity will continue to stay center stage for both trial leaders and patients as creating eCOA solution that integrate seamlessly into the patient’s daily routine – – become a prerequisite for patient participation in clinical research. In this evolution, the use of eCOAs will continue to be in the bedrock of patient-centric experience while enabling more holistic takeaways from clinical studies.

Using eCOA-generated insights ultimately offers a greater opportunity for patients to be heard while providing sponsors with patient-relevant endpoint data that enable a better understanding of the impact and efficacy of a treatment. These critical new capabilities in the space will allow researchers to design trials that patients want to be part of and deliver treatments to market that take their experience into account.