Unlocking new possibilities in clinical trials with eCOA

In today’s clinical research, technology is being used to revolutionize clinical trial operations and enable new types of studies, better patient accessibility, and improved data quality and reliability. This last point is specifically addressed by eCOAs, which stands for electronic clinical outcome assessments.

What is eCOA in a clinical trial?

Electronic clinical outcome assessments, or eCOAs, refer to clinical outcome assessments (COAs) that are collected through electronic means. Clinical outcomes are indicators of how a patient is feeling or responding to treatment throughout a trial, and they are used to determine the effectiveness of the intervention being studied.

COAs are typically collected by physicians and investigators during in-person study visits, whereas eCOAs work by enabling the collection of this data remotely, without the patient needing to visit the study center.

What is the difference between eCOA and ePRO?

Electronic patient-reported outcomes (ePRO) are one type of eCOA wherein patients report on their health outcomes themselves (how they’re feeling, symptom evaluations, taking at-home measurements, etc.) via electronic means. Both ePRO and eCOA are digital data collection methods that enable remote and real-time collection of health outcomes, but eCOA encompasses ePRO as well as other types of electronic data collection such as eClinRO (electronic clinician-reported outcomes) and eObsRO (electronic observer-reported outcomes).

What are the benefits of eCOA in clinical trials for sites and sponsors?

eCOAs are one way to introduce decentralization to clinical trials - eCOAs effectively decentralize the process of health outcome data collection, which would normally occur at trial sites – typically resulting in higher burden for both patients and trial sites alike.

If the study design involves endpoints that can be digitized, then collecting patient outcome data can be one of the simplest aspects of a trial to decentralize by leveraging eCOA tools, which are offered by numerous providers, as we will discuss toward the end of this article.

eCOA can offer many benefits, to investigators and patients alike including:

Increased reliability and organization of clinical outcome data

The consistent and electronic nature of eCOA methods can:

• Reduce bias caused by participants trying to remember how they felt at specific time points in the past (i.e., “parking lot syndrome” where participants fill out their health outcome surveys in the parking lot immediately before a visit), or by fluctuations in measurements due to feeling uncomfortable in clinical settings (i.e., “whitecoat syndrome” where blood pressure can increase in clinical settings)
• Allow for automatic reminders to be sent to patients to fill-in their surveys if they have missed them or are about to miss the deadline (reduces missing data)
• Allow for data validation to be built-in to a certain degree
• Improve data organization as it is collected in a consistent fashion and stored in central or cloud-based servers, as well as data security (as long as appropriate security precautions are implemented)
• Reduce transcription errors from manual data entry

Better patient experience

eCOA allows patients to input or report study data from the comfort of their home, and with more flexibility in terms of time. This reduces travel time, inconveniences including taking time off work and arranging childcare, and also travel costs. Therefore, eCOA is often an important component of patient-centric trials. Patient interactions with the study platform can further be made interactive, to make their trial tasks more enjoyable and feel like less of a burden.

Improved regulatory compliance

eCOA can effectively guarantee each of the attributes the FDA applies to ensuring data integrity through the ALCOA principles:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

Data collected by approved eCOA methods is highly likely to be attributable, legible, contemporaneous, original, and accurate, and in many cases this may make additional data validation steps unnecessary, saving associated time and costs.

Faster and more efficient trials

There are important benefits of the real-time data collection enabled by eCOA:

• Allows for faster response to potential adverse events (AEs)
• Saves time relative to paper-based survey collection during separate in-person visits for each participant
• Shortens the time required between data collection and analysis by ensuring data organization, increasing the speed of its collection, and through built-in quality checks
• Overall, this supports faster clinical trials, which eventually translates into life-saving treatments being made available to patients sooner

Are there any potential challenges involved in adopting eCOA? Is it always possible to switch to eCOA?

Although eCOA are well-established and increasingly common, with numerous third-party vendors offering eCOA services or toolkits and the FDA openly promoting the adoption of such technologies, their adoption still represents an adjustment for sponsors and trial sites from long-standing traditional methods. Further, there are cases where it is simply not feasible to switch to electronic data-collection methods, such as trials measuring complex health endpoints, for example those requiring recurrent MRI scans. Here are some other potential challenges:

Validation of digital endpoints

Electronic surveys need to be checked on the various potential devices participants may use to respond, as it is important that they are displayed consistently between devices and participants, and without errors. Health endpoints need to be validated as well. It is important for time-sensitive measurements to be accurate since they can’t be repeated, and wearable devices and at-home measurement devices should be simple to operate and reliable. It is a good idea to have a support team available to address any issues patients may have as quickly as possible, to avoid missing data points.

Data security and consistency

Databases need to be checked for consistency, both within the server and between the different clinical trial sites, to prevent problems arising from data asynchronicity or corrupted data. Further, data security becomes increasingly important when data is stored on cloud-based servers, as most information collected will be sensitive and thus needs to be appropriately protected in the online environment.

Learning curve for sites and staff during the transition to eCOA methods

The transition to new technologies and digital tools requires additional planning and foresight in terms of setup, validation, and integration into existing systems. It also implies a (potentially significant) adjustment for trial sites and researchers, who may have been using legacy methods. Thus, it is important to acknowledge the potential difficulties in this transition, and to provide adequate time and support for the transition.

Due to the high availability of eCOA solutions on the market, the transition to electronic clinical outcome collection methods can be made much smoother by contracting a third-party vendor and taking advantage of their tested and ready-to-go solutions, including their customer support lines, to help get you started quickly and also to allow for easy troubleshooting of any issues, should they arise. In the next section, we will name some of the top eCOA providers.

5 established eCOA solutions to improve data reliability, patient experience, and the efficiency of your trials

There are companies offering specialized eCOA toolkits that are tried and tested and which can bring the aforementioned benefits of eCOA to your trials with minimal hassle. Let’s take a quick look at the unique features that make these top eCOA providers stand out, so you can make an informed decision and choose a technology that matches the needs of your trial. Note that these companies are not ranked in any particular order.

IQVIA

Currently operating in over 50 countries, IQVIA’s eCOA platform offers more than 1700 ready-to-go eCOA models, and has gathered over 11 million subject responses so far. IQVIA is a trusted leader in the industry and may be a good provider for a wide variety of sponsors.

Signant SmartSignals eCOA

Signant Health’s comprehensive, end-to-end, globally equipped eCOA solution offers various types of eCOA, including ePRO and “complex eClinRO,” counting on more than 50 full-time experts available to help monitor and guide your trial, which may be attractive for sponsors looking for custom solutions. SmartSignals ensures that the data collected in your trial is legible, logical, attributable, accurate, and timely.

Clario eCOA Digital Solutions

With assessments available in over 114 languages and a multi-lingual support desk across numerous time zones, Clario has proven their expertise in bringing decentralized trial solutions to sponsors. They emphasize their rapid setup capacities and fast deployment to help get your trial up-and-running as quickly as possible, and offer an eConsent solution (for electronic informed consent forms, eICFs) and their own “connected devices” for remote collection of some common health outcome endpoints. This may be ideal for sponsors requiring patients to take measurements at home that require specialized devices.

Medable

Medable boasts over 90% reported patient satisfaction over the 1 million patients they have helped in clinical trials. They have completed over 150 studies, and are Fully CFR part 11, GDPR & HIPAA compliant. Their Medable TeleCOA is designed to be maximally flexible to match the needs of your individual study, allowing for any degree of decentralized/hybridized data collection, which makes them a solid partner for sponsors needing customizable solutions.

Medidata Rave eCOA

Medidata offers its unified clinical development platform, for clients and non-clients alike, in a single-system deployment model. The platform, called Rave eCOA, offers the world’s first “standardized eCOA library,” which ecompasses author approval, IRB/ethics packages, and translations, and is fully compliant with ISPOR and CDISC industry standards. Rave eCOA connects easily with Medidata’s other services, such as Rave EDC, Rave eConsent, and their own wearable sensors to provide a truly unified solution that caters to decentralized, hybrid, and site-based trials, making them a great option for sponsors looking for a single-solution provider integrating numerous functions.

Conclusions

In most cases, eCOA reduces burden for sponsors and trial sites, and makes clinical outcome reporting and the overall trial experience better for participants. Although not feasible in 100% of cases, eCOA is already widespread, with services and solutions available that have been extensively tested in real trials and increasing recognition under regulatory frameworks. As one aspect of decentralized clinical trials, eCOA are steadily becoming the “norm,” so partnering with a supplier that fits your needs or developing your own eCOA methodologies is a smart step toward keeping up with the leading trends in clinical research.