Aubrey Llanes, Product Director, eCOA
Technology-driven tools that transform clinical research are key to enhancing clinical trial efficiency, protecting data integrity and helping to bring new therapies to market faster. The use of patient-centric technology, such as electronic clinical outcome assessment (eCOA) tools are an important building block for collecting more reliable endpoint data. Although the benefits are clear, introducing new technology to sites and patients can create additional challenges that can be minimized if anticipated and addressed early in the study planning process.
The first step in improving the clinical research experience for both sites and patients is by reducing the burden on them—minimizing logistical challenges, designing an intuitive user experience, and ensuring these data capture devices are easily integrated into busy lives. Another crucial element to improving the clinical research experience is by anticipating, developing, and implementing comprehensive end-user support that will be needed throughout the study.
Throughout the process of evaluating and selecting a technology partner, and then implementing an eCOA platform, sponsors can sometimes miss an important opportunity to implement a comprehensive end-user support plan. We often think of end-user support as a 24/7 helpdesk. By taking a more holistic approach to end-user education and support, we can significantly reduce frustration among sites and patients—frustration that could jeopardize data quality, site satisfaction, patient compliance, patient retention, and, ultimately, on-time completion of the study. “Educated end-users always produce better outcomes,” said Michael Hughes, Senior Vice President, Product Development.
End-user education and support plans need to be considered and developed early. It is best to begin discussions with potential technology providers before you have completed clinical trial planning. Even if you have already completed your study plan, engage with your technology provider as soon as possible to plan comprehensive end-user education and support. Remember that your technology partner’s science team and project managers have a wealth of experience and knowledge that can be mined to determine the best eCOA modalities that meet your study protocol requirements and the pain points that should be anticipated and addressed for sites and patients.
Comprehensive end-user education and support should include, at minimum, the following elements:
During the feasibility and site selection process, sponsors typically evaluate a site’s capabilities for implementing specific data capture technology. By engaging the technology partner in early discussions about requirements and specifications, sponsors can determine if the site has the right IT infrastructure and internet connectivity and if those elements are available in places where patients are expected to use the patient technology. For example, technology vendors can provide the information needed to create site feasibility assessments, to assess whether the sites and patients have the interest and capabilities to use particular data capture technology.
Site training typically takes place during the Investigator Meeting, either on-site or via video conferencing. From a technology perspective, hands-on training in a face-to-face environment can be much more effective in ensuring focus, engagement, and retention. If that is not feasible, discuss other training modalities with your technology provider to ensure site staff have the information they need to effectively implement the new technology.
A lot of time may elapse between the investigator meeting and first patient in (FPI). So, it’s important for sponsors to work with their technology partners to ensure a detailed training plan is developed and refresher training is available in a variety of modalities such as on-line resources, in-person training, quick reference guides, training integrated into device setup and more. For example, the site initiation visit (SIV) may be a good opportunity to provide remote refresher training.
In addition to the obvious training on how to use the device and software, site training should include the following:
- Thorough explanation of the schedule of assessments and how they are used to contribute data towards clinical trial endpoints
- How to properly prepare the patients to use their devices
- Answers to basic patient questions about their devices and the process for receiving technical support or trial support
- 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
Another way sponsors can help ease the burden on sites and patients is to work with their technology partners to provide easy set-up instructions. Realistically, the first thing that happens is that any user guide that comes with a new device is usually set aside or thrown away. That does not mean they should not be included in the device packaging. It does mean that alternate methods should be provided in order to minimize frustration. Including set-up instructions within the software or creating an intuitive set-up process are excellent ways to ensure device set-up proceeds smoothly. The key here is to discuss these features early on with your technology provider.
Technical support for sites is a critical factor in minimizing disruption to their workflow and ensuring site satisfaction. Technical support for patients is critical in ensuring patient compliance and timely collection of data. Providing helpdesk services directly to patients ensures that resolving technical issues does not fall to site staff who are already overburdened.
Quick resolution of technical issues is key. The longer it takes to reach someone, the longer they remain non-compliant, 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 patients are likely to use their devices. Helpdesk coverage should be provided by knowledgeable staff who can assess the user’s level of comfort with technology, judge the urgency of the issue, make appropriate recommendations, and are empowered to escalate the issue to the right person, if needed.
By anticipating, developing, and implementing comprehensive end-user education and support throughout a clinical research study, sponsors can minimize the burdens created by the introduction of new eCOA technology and thereby improve site satisfaction, improve patient experience, ensure regulatory compliance, and gather more reliable data directly from patients.
Stay tuned for more big news from YPrime related to user support and eCOA solutions.