Setting Sites Up for Success: The Critical First Steps in eCOA Implementation

Leveraging user-friendly technology in clinical trials—particularly electronic clinical outcome assessment (eCOA)—is imperative to enhance data capture and ultimately improve overall trial outcomes. The benefits are clear—eCOA not only improves the efficacy of clinical trials but also enables data integrity by improving user experience. However, the integration of eCOA into existing, often crowded clinical site workflows can be challenging, leading to site and sponsor frustration. It is essential to approach eCOA implementation strategically to mitigate risk and ease the burden on sites. 

Challenges can be mitigated when they are anticipated and addressed early in the study planning process. A critical element in enhancing the research experience lies in the ability to predict, develop, and implement robust end-user support systems throughout the study lifecycle. By embracing a comprehensive approach to end-user education and support, we can significantly reduce potential disruptions, thereby minimizing frustration among sites as they integrate new eCOA technology. This proactive strategy not only facilitates smoother implementation but also cultivates an environment of confidence and collaboration, ultimately leading to more successful clinical outcomes. This article offers solutions to address these challenges and enable successful eCOA implementation.  

Improve Timely Completion with Early Engagement and a Comprehensive Plan

Engage with your technology provider as early as possible to identify the optimal eCOA modalities for your study protocol. Work with your provider to review and prepare for any challenges related to eCOA adoption and implementation. A comprehensive end-user support plan can enhance data quality, reduce site and participant burden, and support participant retention and engagement. At minimum, this plan should include the following elements. 

Site Preparedness

During the feasibility and site selection process, sponsors typically evaluate a site’s capabilities for implementing specific data capture technology. Include your technology partner in early discussions about requirements and specifications to assist you in determining if the site possesses the appropriate IT infrastructure and internet connectivity. Make sure these elements are available in places where participants are expected to use the patient technology. For instance, technology vendors can supply the information required to craft site feasibility assessments and evaluate whether the sites possess the interest and capabilities to employ specific data capture technology.  

Site Training

Site training generally occurs during the investigator meeting, whether on-site or via video conferencing. From a technology standpoint, hands-on training in a face-to-face environment can be far more effective in ensuring focus and technology adoption. With virtual meetings the new norm, remote sessions with a demo of the software can instill confidence in site staff. A hands-on training approach ensures site staff understand the necessary technology specific to study activities and can answer questions to provide support to participants. Site staff knowledge and confidence of the technology is crucial to the adoption and successful use of the systems.  

A significant amount of time may pass between the investigator meeting and the first participant in (FPI). Sponsors must collaborate with their technology partner to ensure a detailed training plan is developed and refresher training is available in various modalities, such as online resources, in-person training, quick reference guides, training integrated into device setup, and more. For instance, the site initiation visit (SIV) may be a great opportunity to provide remote refresher training. 

In addition to the evident training on how to use the device and software, site training should include: 

A comprehensive explanation of the schedule of assessments and how they contribute data toward clinical trial endpoints 

Instructions on how to properly prepare the participants to use their devices 

Answers to basic patient inquiries about their devices and the process for receiving technical support or trial support

Guidance on how to use reports and alerts to monitor patient compliance and to remediate compliance issues

Regular updates, feedback, and tips on any recurring issues with patient compliance 

Setup Instructions 

Another method sponsors can utilize to alleviate the burden on sites and participants is collaborating with their technology partners to provide straightforward setup instructions. Generally, any user guide that comes with a new device is typically set aside or discarded—that doesn’t mean they should be excluded from the device packaging. It implies that alternative methods should be provided to reduce frustration. Including setup instructions within the software or creating an instinctive setup process are effective ways to ensure the device runs seamlessly. The first interaction with the hardware for both the site personnel and the participant is a critical step in the user experience and is consistently overlooked. A thoughtful approach to training and initial device interactions ensures a smooth onboarding process and eliminates stress and anxiety associated with unfamiliar hardware.   

Technical Support 

Technical support for sites is a decisive factor in minimizing disruption to their workflow and ensuring site satisfaction. Technical support for participants is crucial to ensure participant compliance and timely data collection. Offering helpdesk services directly to participants ensures resolving technical issues do not fall on site staff, who are oftentimes already overwhelmed. 

Swift resolution of technical issues is vital. The longer it takes to reach someone, the longer they remain non-compliant and the more stress builds. If 24/7 helpdesk coverage is not possible, it is important to ensure coverage is available during data entry windows specified in the protocol and when participants are likely to use their devices. Helpdesk coverage should be provided by knowledgeable staff who can assess the user’s comfort level with technology, judge the issue’s urgency, make appropriate recommendations, and be empowered to escalate the matter to the right person if required. 

By predicting, formulating, and executing comprehensive end-user education and support throughout a clinical research study, sponsors can offset the potential burdens created by introducing new eCOA technology—ultimately improving site satisfaction, enhancing participant experience, ensuring regulatory compliance, and gathering more reliable data directly from participants. 

Exploring and evaluating new eCOA solutions can be a daunting task. Learn more about the right questions to ask eCOA vendors in our eCOA checklist.