Ready for Remote: eCOA Adapts to a Hybrid World

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Ready for Remote: eCOA Adapts to a Hybrid World

Due to the global health impact of COVID-19, many aspects of daily life have been moved to a hybrid model, meaning a mix of in-person and technology-enabled interactions. Of course, the same has happened in medical research and clinical trials. As a result, the use of electronic clinical outcome assessments (eCOAs) has dramatically increased as sponsors seek out new and innovative ways to capture patient data in a hybrid environment.

Let’s get into why eCOAs are especially well-suited for hybrid clinical trials.

First, what’s the difference between virtual, hybrid, and decentralized clinical trials?

Although these are all relatively new terms with somewhat fluid definitions, there is basic agreement on the fundamentals for each type of clinical trial:

Virtual Clinical Trial

- The entire trial is remote and mediated by technology, meaning there are no physical locations or face-to-face interactions

Hybrid Clinical Trial

- Includes a mix of onsite, face-to-face interactions, in addition to remote, technology-enabled communications and data collection

Decentralized Clinical Trial

- These trials can be either entirely virtual or hybrid, employing whichever technology best suits the protocol, be it Televisits, eCOA, remote consents (TeleConsent), Bring Your Own Device (BYOD), among many more

- Operations of a clinical trial that are decentralized, using technology to communicate with study participants and collect data

- As there is no “centralized” location, researchers can also choose to partner with sites near patients for onsite visits and face-to-face care anywhere in the world, which means a more inclusive, equitable future for medicine is possible

So, why are eCOAs particularly well suited to hybrid clinical trials?

When it comes to collecting COAs, new technology enables expansive freedom for researchers, allowing for reliable data capture both in-office and remote. A few brief examples include:

- Measuring clinician reported outcomes (ClinRO) over a Televisit

- Measuring patient reported outcomes (PRO) with patient directed surveys on mobile apps

- Measuring observer reported outcomes (ObsRO) on mobile apps with a care partner’s assistance at home

- Generating performance outcomes (PerfO) with device data

- Wearables like watches, wristbands, rings, and connected patches are now more affordable and available

- Patient reported data – such as walking speed, sleep amounts, and heart rate – can be reliably and frequently captured remotely

The built-in flexibility offered by eCOAs allows researchers to now collect more data, more frequently, thereby enhancing the ability to add endpoints that help capture a more complete picture of trial results, as well as assess health-related quality-of-life impacts.

In addition, the modular and highly scalable nature of eCOAs also allows for the addition of measurements that may be needed for a specific clinical trial, as well as longitudinal data collection that may be analyzed to provide early warning of declining health and adverse events. Since this remote monitoring can be done at scale in a modular fashion, it could potentially improve retention as patients may receive more personalized care and attention.

Regulatory Agencies and eCOAs

The use of eCOAs can also make for a smoother regulatory submission process. As we’ve discussed in previous articles, the FDA and EMA have both published guidance supporting the use of electronic data capture. The FDA also provides clear guidance on the use of electronic forms and signatures in relation to Good Clinical Practice (GCP), as stipulated in 12 CFR Part 11.  

In fact, regulatory agencies prefer eCOAs, because they provide superior data collection and quality compared to paper-based COAs. This in turn supports a clinical trial’s ALCOA compliance, which is the fundamental principles that allow for paper and electronic data integrity.

ALCOA is an acronym for:

- Attributable

- Legible

- Contemporaneous

- Original

- Accurate

Given the preference of regulatory agencies for the superior data collection provided by eCOAs, sponsors now have much greater flexibility in how healthcare and clinical trial services can be provided.

How do I know if an eCOA works for my study?

The feasibility of eCOAs depends on many factors and demands an in-depth understanding of the disease and the condition, followed by evaluating which COAs are needed for the protocol—and then determining which COAs are suitable for technology-enabled remote capture.

An in exhaustive list of factors to consider includes:

  • Therapeutic area
  • Disease
  • Disease stage
  • Disease prevalence
  • Patient preference
  • Access to technology
  • Privacy
  • Safety

Customizing to Meet the Needs of Patients and Protocols

Regardless of modality, an important requirement of remote eCOAs is that they provide valid, reliable and meaningful endpoints equivalent to onsite COAs. In other words, to be considered as endpoints, eCOAs must meet the fundamental requirements for an informative measure that addresses how patients feel, function, or survive.

In addition, they should be adaptable and able to meet both patient and protocol needs. For example, strong demand from patients for Televisits spurred the development of Medable TeleCOA, which can connect with patients on any device to engage and enable participation in the clinical trial, from recruitment forward. As most patients would prefer to stay home rather than conduct onsite visits, studies with fewer onsite visits are likely to engage and retain more patients, which ultimately translates to more data for the clinical trial.

Ready to get started with eCOAs? We’re the experts in eCOAs and hybrid clinical trials, and we’re excited to partner with you. Contact us today!