Innovations in Urology Clinical Trials and DCTs

Digital Patient Training is Essential

While the endpoints in urology clinical trials typically require the report of common patient symptoms, studies show that many commonly used terms are not uniformly or well understood by patients. At SPRIM Health, our studies show that many of the concepts associated with primary endpoints in urology studies such as a voiding diary are nebulous to patients. For example, reporting on voiding episodes, accidental leakage, urge versus stress induced events can be difficult for patients to understand how to do without the use of definitions and digital patient training to ensure comprehension and compliance with the protocol requirements. Additionally, minimization of the placebo effect through training is also a necessary component to improving the signal to noise ratio. As such, there is a critical need for digitally training patients in urology clinical trials, hybrid studies and decentralized clinical trials (DCTs).

Development and Validation of Novel ePRO

In urology trials, the primary endpoints are frequently ePRO based and involve a customized voiding eDiary that can contain more complex branching logic to capture voiding events. It is essential to develop and validate the content for voiding eDiaries using cognitive debriefing and usability testing patient interviews. Diary design needs to be simple, the content clear and engaging with minimal burden on patients. Given the routine nature of urology events, it is critical to utilize ePRO technology to facilitate compliance by using notifications, reminders and alarms. Technology can enable algorithms and central monitors to respond to potential AEs/SAEs in real and near real time. At SPRIM Health, we have considerable experience in developing and validating FDA-approved voiding eDiaries for use in large global clinical trials and DCTs.