3 Key Reasons to Implement an eCOA Strategy for Clinical Trials

By Kris Gustafson, Vice President and Global Head IQVIA eCOA, IQVIA

As the health industry rapidly shifts to more patient-centric approaches to care and clinical research, technology is just as quickly becoming the cornerstone to effectively engage clinical study participants. Electronic clinical outcome assessments (eCOAs) are essential to ensuring that each clinical trial is optimized for the patient’s experience by being faster, more on-demand, and more customizable. With the ability to design decentralized trials with patients’ daily lives, preferences, and needs in mind, a thoughtful strategy around eCOAs simultaneously increases the operational efficiency of trials, as well as their data integrity, regulatory compliance, and more.

The Forcing Factors for eCOA Adoption

In clinical research, gathering patient perspectives is critical in understanding patient-reported outcomes (PROs). Historically, this has been done through hand-written patient assessments, a tedious part of data collection and analysis for both the patient and the sponsor.

Trials that utilize paper-based assessments leave the possibility of holes in the database due to the various responsibilities of manual reporting by the patient. This could include daily summaries of how they are feeling, quantitative or qualitative measures timed to relevant moments in the day, or much more depending on the specificities of the study design. This not only leaves a large burden on the patient to not only complete the assessments legibly and in accordance with their respective pre-defined schedule, but also opens the possibility to delay sponsors’ access to the data if data is completed incorrectly – or worse, not at all.

The move to leverage eCOA technology stems from a need for versatility. The ability of various technologies – such as smartphones, tablets, computers, or other integrated devices – to deploy eCOAs enables better data quality and compliance in comparison to paper-based systems – giving trial participants a platform to report their experiences and increasing the likelihood of product regulatory approval for the sponsors.

Key Benefits of an eCOA Strategy 

With various trials and complex protocols, there are many challenges to engaging with and keeping qualified patients for a trial. Life sciences companies must leverage innovative technology solutions that easily integrate data and improve the trial experience. Developing strategic hybrid or decentralized trial elements and fit-for-purpose eCOA tools helps strengthen patient engagement, data quality, and efficiency.

eCOA technology converts assessments into a real-time digital asset that collects insights directly from the patient about their disease, their experience participating in the trial, and the treatment’s impact on their quality of life. This opens the door to three key benefits for clinical researchers:

  1. Maximized time and efficiency

Because data is captured electronically and eliminates the need to transcribe handwritten data into a digital database, countless hours can be saved for the onsite manual labor that must decipher and input handwritten notes. The time saved can convert to reduced trial costs and faster time to market, which can equate to better patient outcomes, a more competitive edge in the industry, and greater return on investment at large.

  1. Real-time insights that inform trial progress

An eCOA enables patients to complete their diaries online, allowing the technology to receive their submitted data instantly and upload it to the trial database. This allows trials sites and sponsors to get real-time insight into the patient experience as opposed to waiting weeks for diaries to be submitted and entered manually. The immediate access to accurate data and insights can contribute to a safer patient environment and deliver faster results on the study.

  1. Improved data quality and compliance

When patient engagement is high, there is a parallel increase in patient protocol compliance. Because eCOAs make it easier for patients to seamlessly access and send in their entries and recording details timestamps of entry, they exceed compliance levels. Paper data collection, on the other hand, has a greater chance of decreased compliance due to the lack of consistency to show effective engagement from patients and lack of controls over data entry timeliness or quality. Data quality is important because sponsors need to be confident in the reliability of the data. With real-time data streams and exact timestamping of data entries, it improves the quality of the data coming in for a given study. Additional benefits include data encryption and easier integration with other data sources.   

Adapting to the Future of Clinical Innovation

Although life sciences companies are often reluctant to introduce new strategies to their clinical research workflow, there is great value in implementing technology driven strategies like those for eCOAs. With the opportunity for trial sponsors to foster better patient centricity and experience for their patients, eCOAs alleviate wasted time and add value for all parties.

Kris Gustafson

Going forward, sponsors should look to implement an eCOA strategy to not only provide a superior and more flexible user experience for study teams and patients, but also to gain faster access to higher quality data, recruit and retain patients more easily, and improve their patient compliance. These efforts will contribute to better ROI on trials and more comprehensive study findings that lead to better treatments going to market for the patients that need them.