Two such tools – electronic patient-reported outcomes (ePRO) and electronic clinical outcomes assessments (eCOA) – are often mentioned together. However, they serve distinct purposes and come with different considerations for clinical trial sponsors and contract research organisations (CROs). Understanding these differences is vital for selecting the right technology and provider to meet your trial needs.

What is ePRO?

ePRO systems are designed to electronically collect data directly from patients about their health condition, quality of life, and treatment experience without mediator interpretation. This technology enables patients to report outcomes using devices such as smartphones, tablets, or computers, ensuring that data collection is more immediate and reflects the patient’s perspective.

However, ePRO is far more than just digitising patient surveys. It is a scientific approach that demands careful consideration of the patient’s journey, the usability of the technology, and the methodological rigour in the design and validation of the questionnaires. An effective ePRO system needs to account for the patient population’s technological literacy, the accessibility of devices, and must maintain the integrity and security of the data collected.

What is eCOA?

eCOA encompasses a broader spectrum of assessments, including ePRO, as well as clinician-reported outcomes (ClinROs), observer-reported outcomes (ObsROs), and performance outcomes (PerfOs). eCOA systems are used to electronically capture all these data types, making it a more comprehensive tool than ePRO.

The complexity of eCOA systems extends beyond just technology. It involves the integration of multiple types of assessments, each potentially requiring different technological and methodological approaches. For instance, while an ePRO might require a simple interface for patient input, a ClinRO could necessitate more complex features – such as integration with clinical management systems or tools for healthcare providers.

Choosing between ePRO and eCOA providers

It’s crucial to recognise that not all ePRO providers are equipped to offer eCOA services. The latter requires handling a broader array of data types and more complex system integrations. Critical questions sponsors and CROs should ask when considering an eCOA or ePRO vendor are:

  • Expertise and experience: Does the vendor have a proven track record with the specific type of data collection you need (ePRO, ClinRO, ObsRO, PerfO)?
  • System compatibility: Can their system integrate seamlessly with your existing clinical trial management systems?
  • Compliance and security: Does the system comply with regulatory requirements? How does the vendor ensure data privacy and security?
  • Support and training: What level of technical support and training does the vendor offer?

Additional Considerations for eCOA

Choosing an eCOA provider often involves more complexities than selecting an ePRO provider. Additional factors that must be considered are:

  • Translation and localisation: Clinical trials are global, necessitating the translation of assessment tools into multiple languages. Sponsors should inquire about the vendor’s capabilities and timelines for translating and localizing content, which can significantly impact trial timelines
  • Licensing of assessments: Unlike some homegrown ePRO measures, many COAs are proprietary scales that require licensing. It’s important to understand the costs and the process involved in licensing these assessments from the developers

Why take ePRO seriously?

While ePRO might seem simpler compared to eCOA, it demands a rigorous scientific approach. The design of ePRO systems must consider factors like questionnaire design, the timing of assessments, and the patient’s ability to use the technology. Missteps in any of these areas can lead to unreliable data, potentially compromising the trial’s outcomes.

In conclusion, while ePRO and eCOA are pivotal in modern clinical trials, they serve distinct roles with different complexities. Understanding these nuances helps in making informed decisions about the appropriate systems and providers, ensuring the successful collection of accurate and reliable data in clinical trials.

To learn more about platforms that can improve patient engagement in clinical trials, download the document below.