The promise of decentralised clinical trials (DCTs) was recognised during Covid-19, but in the following years, sponsors and contract research organisations (CROs) have hit many barriers, resulting in low adoption rates of DCTs.

However, the successful execution of these trials hinges on meticulously crafted strategies and the right technological support. A significant area of concern that has been overshadowed by the surge of DCTs is the emphasis on electronic clinical outcome assessments (eCOA).

This article focuses on the common pitfalls of decentralised trials and underscores the vital role of eCOA, advocating for a balanced approach that prioritises core technologies while integrating supplementary services such as home nursing and telehealth.

Why eCOA should not be overlooked in DCTs

One of the key mistakes in DCTs is the diminished focus on eCOA, a cornerstone technology in these trials. eCOA refers to the use of electronic systems to capture patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. eCOA is the backbone of data collection in clinical trials, ensuring accuracy, compliance, and real-time monitoring of patient health metrics.

The attraction of additional features such as home nursing, telehealth services, and wearable or sensor integration has led to a disproportionate emphasis on these elements. While these services add value by enhancing patient engagement and accessibility, they should not overshadow the core technological components such as eCOA.

Home nursing and telehealth are flexible and can be quickly adapted or restructured in the event of challenges. However, if the eCOA system is flawed or inadequate, it can compromise the entire trial's data integrity and validity.

The advantages of an effective eCOA system for clinical trials

eCOA systems directly influence the quality of data collected in clinical trials. An efficient eCOA system ensures:

• Higher data accuracy by reducing manual errors associated with paper-based assessments
• Improved patient compliance with user-friendly interfaces and real-time feedback mechanisms
• Timely data capture, allowing for immediate intervention and adjustment in trial protocols if necessary
• Regulatory compliance, meeting stringent data standards set by health authorities

Strategies for prioritising eCOA in DCTs

To ensure the success of decentralised trials, sponsors and CROs must refocus on eCOA. The key strategies to achieve this are:

• Comprehensive vendor evaluation. When selecting technology vendors for DCTs, prioritise those with robust and proven eCOA solutions. Assess their track record, data security measures, and the scalability of their systems
• Integrated approach. While incorporating supplementary services such as home nursing, ensure these services are seamlessly integrated with the eCOA platform. This integration enhances patient experience without compromising data quality
• User-centric design. The eCOA system should be designed with the end-user in mind – the patients. A user-friendly interface increases patient engagement and compliance.
• Training and support. Invest in comprehensive training programs for patients and site staff to ensure effective use of the eCOA system. Continuous support and troubleshooting mechanisms are essential
• Pilot testing. Before rolling out the eCOA system in a full-scale trial, conduct pilot tests to identify and address potential issues proactively
• Continuous monitoring and evaluation. Regularly monitor the performance of the eCOA system and make adjustments as needed. This proactive approach can mitigate risks and enhance the overall quality of the trial

How to deliver successful decentralised clinical trials

In conclusion, while home nursing, telehealth, wearables, and sensors are important in enhancing the patient experience in decentralised trials, they should not eclipse the fundamental role of eCOA systems.

A successful DCT maintains a balanced focus on both core and supplementary technologies. By prioritising eCOA, sponsors and CROs can safeguard the integrity and effectiveness of clinical trials, ultimately leading to more reliable and impactful health research outcomes.