Once your team has made the decision to collect digital measures in your clinical trial and selected a fit-for-purpose digital health technology (DHT), it’s time to prepare to go live. This step is critical because failures during DHT deployment can result in poor data collection, ultimately limiting your insight into participants’ health and behavior during the study. To avoid common pitfalls and ensure deployment runs smoothly, it's important to plan carefully and engage your technology partner in the process.
Clinical research sites are a crucial element of the operational process, and they have the ability to make or break the success of technology deployment. However, with ever increasing levels of site complexity comes a higher likelihood that digital measures can become deprioritized. When research sites get excited about this data, that enthusiasm is passed along to study participants, thereby encouraging protocol adherence.
The first step to aligning with clinical research sites on your wearable DHT goals is proper training. Make sure the site team fully understands what the technology is measuring, why these measures are important, and how to operate the devices before they are assigned to participants. Technology training materials for both sites and participants should be simple and customized to each study protocol. In-person hands-on demos with the site team are preferred, as it makes it easier for them to understand how and why the technology is being used. It’s also helpful to provide the sites with supporting materials, such as relevant white papers that demonstrate how these digital measures will benefit the participants.
During deployment, issues or questions from participants may arise, so the sites should be prepared to address them. Typically, the wearable technology partner will provide technical support for deployed devices, but in many cases the site will be participants’ first point of contact. Setting time aside during site visits to discuss any concerns will help optimize participant adherence. Site teams should also be equipped with the appropriate FAQs and contact information to address any questions or issues.